Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-28 @ 3:58 AM
Study NCT ID:
NCT03981003
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2019-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Neurofilament-light Chain and GFAP Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'C537987', 'term': 'Charcot-Marie-Tooth disease, Type 1F'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-13', 'studyFirstSubmitDate': '2019-05-23', 'studyFirstSubmitQcDate': '2019-06-07', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with evolving disease compared to those with stable disease', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with evolving disease compared to those with stable disease', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease', 'timeFrame': '12 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with evolving disease compared to those with stable disease', 'timeFrame': '12 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with evolving disease compared to those with stable disease', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with evolving disease compared to those with stable disease', 'timeFrame': '3 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with evolving disease compared to those with stable disease', 'timeFrame': '4 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with evolving disease compared to those with stable disease', 'timeFrame': '5 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with evolving disease compared to those with stable disease', 'timeFrame': '6 years', 'description': 'pg/mL; measured by digital ELISA'}], 'secondaryOutcomes': [{'measure': 'Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.', 'timeFrame': '3 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.', 'timeFrame': '4 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.', 'timeFrame': '5 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.', 'timeFrame': '6 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with relapse compared to stable patients', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with relapse compared to stable patients', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with relapse compared to stable patients', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with relapse compared to stable patients', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with relapse compared to stable patients', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with relapse compared to stable patients', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with relapse compared to stable patients', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with relapse compared to stable patients', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with relapse compared to stable patients', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with isolated MRI activity compared to stable patients', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'GFAP level in patients with isolated MRI activity compared to stable patients', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity compared to stable patients', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity compared to stable patients', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity compared to stable patients', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients', 'timeFrame': '2 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients', 'timeFrame': '2 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with disease activity (relapse or MRI activity)', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with disease activity (relapse, or MRI activity)', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with disease activity (relapse, or MRI activity)', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with disease activity (relapse or MRI activity)', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with disease activity (relapse or MRI activity)', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with disease activity (relapse or MRI activity)', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with relapses', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with relapses', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with relapses', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with relapses', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with relapses', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with relapses', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with relapses', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with relapses', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with relapses', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with relapses', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with MRI activity', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with MRI activity', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with MRI activity', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with MRI activity', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with MRI activity', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with MRI activity', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with MRI activity', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with MRI activity', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with MRI activity', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with MRI activity', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement', 'timeFrame': '6 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement', 'timeFrame': '1 year', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement', 'timeFrame': '18 months', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement', 'timeFrame': '2 years', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Level of disability', 'timeFrame': 'Inclusion', 'description': 'Expanded Disability Status Scale (EDSS); scale 1= no disability to 10 = death from multiple sclerosis'}, {'measure': 'Level of disability', 'timeFrame': 'Relapse (measured up to 2 years)', 'description': 'Expanded Disability Status Scale (EDSS); scale 1= no disability to 10 = death from multiple sclerosis'}, {'measure': 'Severity of multiple sclerosis', 'timeFrame': 'EDSS progression (measured up to 2 years)', 'description': 'Multiple Sclerosis Functional Composite'}, {'measure': 'Severity of multiple sclerosis', 'timeFrame': 'Active MRI (measured up to 2 years)', 'description': 'Multiple Sclerosis Functional Composite'}, {'measure': 'Generic health status', 'timeFrame': 'Inclusion', 'description': 'EuroQol 5 dimension questionnaire (EQ-5D)'}, {'measure': 'Generic health status', 'timeFrame': 'Relapse (measured up to 2 years)', 'description': 'EuroQol 5 dimension questionnaire (EQ-5D)'}, {'measure': 'Generic health status', 'timeFrame': 'EDSS progression (measured up to 2 years)', 'description': 'EuroQol 5 dimension questionnaire (EQ-5D)'}, {'measure': 'Generic health status', 'timeFrame': 'active MRI (measured up to 2 years)', 'description': 'EuroQol 5 dimension questionnaire (EQ-5D)'}, {'measure': 'Use of Disease Modifying Drugs', 'timeFrame': 'Inclusion', 'description': 'Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)'}, {'measure': 'Use of Disease Modifying Drugs', 'timeFrame': '6 monrths', 'description': 'Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)'}, {'measure': 'Use of Disease Modifying Drugs', 'timeFrame': '1 year', 'description': 'Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)'}, {'measure': 'Use of Disease Modifying Drugs', 'timeFrame': '18 months', 'description': 'Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)'}, {'measure': 'Use of Disease Modifying Drugs', 'timeFrame': '2 years', 'description': 'Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)'}, {'measure': 'Serum Neurofilament Light Chain in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients', 'timeFrame': 'Month 6', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients', 'timeFrame': 'Month 6', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion', 'timeFrame': 'Inclusion', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum Neurofilament Light Chain in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion', 'timeFrame': 'Month 6', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Serum GFAP in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion', 'timeFrame': 'Month 6', 'description': 'pg/mL; measured by digital ELISA'}, {'measure': 'Create biobank', 'timeFrame': 'Inclusion', 'description': 'Blood samples'}, {'measure': 'Create biobank', 'timeFrame': '6 months', 'description': 'Blood samples'}, {'measure': 'Create biobank', 'timeFrame': '1 year', 'description': 'Blood samples'}, {'measure': 'Create biobank', 'timeFrame': '18 months', 'description': 'Blood samples'}, {'measure': 'Create biobank', 'timeFrame': '2 years', 'description': 'Blood samples'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neurofilament-light chain', 'Glial fibrillary Acidic Protein (GFAP)'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that serum neurofilament-light chain (NfL) levels can provide information about the level of activity and progression of Multiple Sclerosis at different stages and landmarks of the disease.\n\nIn addition, Glial Fibrillary Acidic Protein (GFAP) has also been identified as another serum biomarker of disability in MS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is composed of consecutive patients over 15 years of age, of both sexes, recruited during consultations for a CIS, RRMS or progressive MS at the Neurology department of 30 OFSEP centres and of Nîmes and Nantes University Hospitals. The patients recruited will have an EDSS score comprised between 0 - 7.0.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient has been correctly informed.\n* The patient must have given their informed and signed consent.\n* The patient must be insured or beneficiary of a health insurance plan.\n* The patient is at least (≥)15 years old.\n* The patient has MS according to diagnosis criteria (Thompson et al. 2017) and:\n\n * Participates to the OFSEP-HD cohort (ancillary study);\n * Has a Expanded Disability Status Scale score comprised between 0 - 7.0;\n * With or without Disease Modifying Drug;\n * For Work Package 3: patients enrolled in any OFSEP-HD centre that meet landmark criteria for an active MS (relapse, or Expanded Disability Status Scale progression, or active MRI) during follow-up;\n * For Work Package 4: patients with a stable disease enrolled in OFSEP-HD study in Nîmes or Nantes University Hospitals.\n\nExclusion Criteria:\n\n* Within the past three months, the patient has participated in another interventional study that may interfere with the results or conclusions of this study.\n* The patient is in an exclusion period determined by a previous study.\n* The patient is under judicial protection.\n* The patient refuses to sign the consent.\n* It is impossible to correctly inform the patient (inability to understand the study, language problem).\n* The patient is pregnant or breast-feeding.\n* The patient is under 15 years old.\n* Inability to answer questionnaires.\n* Clinically isolated syndrome (CIS) that does not meet the criteria of MS.\n* Radiologically isolated syndrome (RIS).\n* Patient with Neuromyelitis optica spectrum disorder.'}, 'identificationModule': {'nctId': 'NCT03981003', 'acronym': 'NeurofilMS', 'briefTitle': 'Serum Neurofilament-light Chain and GFAP Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Serum Neurofilament-light Chain and Glial Fibrillary Acidic Proten (GFAP) Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'CIVI/2018/ET-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MS Patients', 'interventionNames': ['Diagnostic Test: Blood sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'DIAGNOSTIC_TEST', 'description': '2 x 4 ml tubes blood to screen for serum Neurofilament Light Chain and GFAP levels', 'armGroupLabels': ['MS Patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Abdullatif AL KHEDR', 'role': 'CONTACT', 'email': 'AlKhedr.Abdullatif@chu-amiens.fr'}, {'name': 'Abdullatif AL KHEDR', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CHU d'Amiens", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Besançon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eric BERGER', 'role': 'CONTACT', 'email': 'eberger@chu-besancon.fr'}, {'name': 'Eric BERGER', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Besancon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Bordeaux', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bruno BROCHET', 'role': 'CONTACT', 'email': 'bruno.brochet@chu-bordeaux.fr'}, {'name': 'Bruno BROCHET', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Aurélie RUET', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Caen', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nathalie DERACHE', 'role': 'CONTACT', 'email': 'derache-n@chu-caen.fr', 'phone': '02 31 06 46 17'}, {'name': 'Nathalie DERACHE', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gilles DEFER', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Clermont-Ferrand', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre CLAVELOU', 'role': 'CONTACT', 'email': 'pclavelou@chu-clermontferrand.fr', 'phone': '04 73 75 22 01'}, {'name': 'Pierre CLAVELOU', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dominique AUFAUVRE', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Frédéric TAITHE', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xavier MOISSET', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Clermont Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Créteil', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alain CREANGE', 'role': 'CONTACT', 'email': 'alain.creange@hmn.aphp.fr'}, {'name': 'Alain CREANGE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Dijon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thibault MOREAU', 'role': 'CONTACT', 'email': 'thibault.moreau@chu-dijon.fr', 'phone': '03 80 29 55 84'}, {'name': 'Thibault MOREAU', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Agnès FROMONT', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dominique AUDRY', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gwendoline DUPONT', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Grenoble', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier CASEZ', 'role': 'CONTACT', 'email': 'ocasez@chu-grenoble.fr', 'phone': '04 76 76 58 71'}, {'name': 'Olivier CASEZ', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mathieu VAILLANT', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hélène ZEPHIR', 'role': 'CONTACT', 'email': 'helene.zephir@chru-lille.fr', 'phone': '03 20 44 60 53'}, {'name': 'Helene ZEPHIR', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Limoges', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent MAGY', 'role': 'CONTACT', 'email': 'laurent.magy@unilim.fr', 'phone': '05 55 05 65 61'}, {'name': 'Laurent MAGY', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alexis MONTCUQUET', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Lyon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sandra VUKUSIC', 'role': 'CONTACT', 'email': 'sandra.vukusic@chu-lyon.fr', 'phone': '04.72.35.75.22'}, {'name': 'Sandra VUKUSIC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Françoise DURAND-DUBIEF', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean PELLETIER', 'role': 'CONTACT', 'email': 'jean.pelletier@ap-hm.fr'}, {'name': 'Jean PELLETIER', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montpellier', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre LABAUGE', 'role': 'CONTACT', 'email': 'labauge@yahoo.fr'}, {'name': 'Pierre LABAUGE', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xavier AYRIGNAC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Clarisse CARRA', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nancy', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc DEBOUVERIE', 'role': 'CONTACT', 'email': 'm.debouverie@chu-nancy.fr'}, {'name': 'Marc DEBOUVERIE', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sophie PITTION VOUYOVITCH', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Nice', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christine Lebrun-Frenay', 'role': 'CONTACT', 'email': 'lebrun.c@chu-nice.fr', 'phone': '04 92 03 78 98'}, {'name': 'Christine Lebrun-Frenay', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Veronique Bourg', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mikaël Cohen', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '30029', 'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anissa Megzari', 'role': 'CONTACT', 'email': 'drc@chu-nimes.fr', 'phone': '04.66.68.42.36'}, {'name': 'Eric Thouvenot, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier GOUT', 'role': 'CONTACT', 'email': 'ogout@fo-rothschild.fr'}, {'name': 'Olivier GOUT', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Romain DESCHAMPS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fondation Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine LUBETZKI', 'role': 'CONTACT', 'email': 'catherine.lubetzki@psl.aphp.fr'}, {'name': 'Catherine LUBETZKI', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Caroline PAPEIX', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hopital Pitie Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bruno Prénom Bruno Bruno STANKOFF', 'role': 'CONTACT', 'email': 'bruno.stankoff@sat.aphp.fr'}, {'name': 'Bruno STANKOFF', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Poissy', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier HEINZLEF', 'role': 'CONTACT', 'email': 'oheinzlef@chi-poissy-st-germain.fr', 'phone': '01 39 27 41 81'}, {'name': 'Olivier HEINZLEF', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH de Poissy', 'geoPoint': {'lat': 48.92902, 'lon': 2.04952}}, {'city': 'Potiers', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean Philippe NEAU', 'role': 'CONTACT', 'email': 'jean-philippe.neau@chu-poitiers.fr', 'phone': '05 49 44 44 46'}, {'name': 'Jean Philippe NEAU', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lauriane CHAMBRIER', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nicolas MAUBEUGE', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fanny SOURDRILLE', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Potiers', 'geoPoint': {'lat': 49.40483, 'lon': 0.39166}}, {'city': 'Rennes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emanuelle LE PAGE', 'role': 'CONTACT', 'email': 'infirmieres.recherche-clinique@chu-rennes.Fr'}, {'name': 'Emanuelle LE PAGE', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gilles EDAN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dr MICHEL', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bertrand BOURRE', 'role': 'CONTACT', 'email': 'bertrand.bourre@chu-rouen.fr', 'phone': '02 32 88 33 99'}, {'name': 'Bertrand BOURRE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Saint-Etienne', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean Philippe CAMDESSANCHE', 'role': 'CONTACT', 'email': 'j.philippe.camdessanche@chu-st-etienne.fr', 'phone': '04 77 12 78 05'}, {'name': 'Jean Philippe CAMDESSANCHE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Strasbourg', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérôme DE SEZE', 'role': 'CONTACT', 'email': 'jerome.de.seze@chru-strasbourg.fr', 'phone': '03 88 12 85 44'}, {'name': 'Jérôme DE SEZE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Damien BIOTTI', 'role': 'CONTACT', 'email': 'biotti.d@chu-toulouse.fr'}, {'name': 'Damien BIOTTI', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jonathan CIRON', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne-Marie GUENNOC', 'role': 'CONTACT', 'email': 'guennoc@univ-tours.fr', 'phone': '02 47 47 80 23'}, {'name': 'Anne-Marie GUENNOC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Fort-de-France', 'status': 'NOT_YET_RECRUITING', 'country': 'Martinique', 'contacts': [{'name': 'Philippe CABRE', 'role': 'CONTACT', 'email': 'pcabre_fr@yahoo.fr'}, {'name': 'Philippe CABRE', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Emeline Berthelot', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Martinique', 'geoPoint': {'lat': 14.60365, 'lon': -61.07418}}], 'centralContacts': [{'name': 'Eric Thouvenot', 'role': 'CONTACT', 'email': 'eric.thouvenot@chu-nimes.fr', 'phone': '+33.(0)4.66.68.32.61'}], 'overallOfficials': [{'name': 'Eric Thouvenot', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Nimes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}