Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-01 @ 12:51 PM
Study NCT ID:
NCT01804660
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2013-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Normal Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum, plasma and PBMC.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-19', 'studyFirstSubmitDate': '2013-03-04', 'studyFirstSubmitQcDate': '2013-03-04', 'lastUpdatePostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establish a control value for the levels of MSRV expression in the normal population over time', 'timeFrame': '1 year', 'description': 'Establish a control value for the levels of MSRV expression in the normal population over time using 3 approaches:\n\n* MSRV transcripts in PBMC;\n* MSRV transcripts in plasma;\n* MSRV-Env protein in serum.'}], 'secondaryOutcomes': [{'measure': 'Inflammatory markers and reverse transcriptase activity in blood.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis (MS)', 'Multiple Sclerosis associated RetroVirus (MSRV)', 'MSRV envelop protein (MSRV-Env)', 'Temelimab'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This study intends to explore the levels of MSRV expression by analyzing the levels of MSRV transcripts in blood, as well as the levels of the MSRV-Env protein in serum in the normal population. This study is important for establishing a baseline to analyze results obtained in MS patients (another dedicated study is performed in parallel in MS patients). The study will be conducted over one year in a cohort of healthy subjects. The MSRV RNA level, MSRV-Env protein levels, reverse transcriptase activity, inflammatory markers assessed by cytokines levels will be analysed to define control levels in the normal population and their variation during one year. The data obtained in this study in healthy controls will be compared to those obtained in a parallel similar study, GN-E-002, conducted in different types of MS patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Blood donors coming for regular blood draw in the center of transfusion.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signature of an informed consent;\n* Male or female between 18 and 60 years of age.\n\nExclusion Criteria:\n\n* Positive serology for hepatitis B or C or HIV;\n* Acute infection at inclusion;\n* Severe psychiatric disorder, neurological, inflammatory, or autoimmune disease;\n* Pregnancy or breastfeeding;\n* Heavy smokers i.e. more than 10 cigarettes per day;\n* History of alcohol or drug abuse in the last 3 years;\n* Participation in a clinical trial (within the last 3 months).'}, 'identificationModule': {'nctId': 'NCT01804660', 'acronym': 'CONTROL', 'briefTitle': 'Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Normal Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'GeNeuro SA'}, 'officialTitle': 'A One Year Longitudinal Therapeutically Non-Interventional Study of MSRV-Env Burden in Normal Population as Assessed by PCR and ELISA in Blood', 'orgStudyIdInfo': {'id': 'GN-E-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': '25 healthy volunteers', 'description': 'No study treatments administered', 'interventionNames': ['Other: No study treatments administered']}], 'interventions': [{'name': 'No study treatments administered', 'type': 'OTHER', 'armGroupLabels': ['25 healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74100', 'city': 'Annemasse', 'country': 'France', 'facility': 'Etablissement Français du Sang Rhône Alpes - 1 route de Taninges', 'geoPoint': {'lat': 46.19439, 'lon': 6.23775}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GeNeuro Innovation SAS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}