Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-29 @ 1:43 AM
Study NCT ID:
NCT01157468
Status:
COMPLETED
Last Update Posted:
2016-09-08
First Post:
2010-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Catalytic Antibodies and Lupus in Martinique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* For the "case" means the research will be done on a blood sample of 7 ml, reclassified from treatement to research, collected from the blood sampling usually prescribed by doctors to treat the patient come to be diagnosed a lupus or for continuing care.\n* For the "control" means research will be done on a blood sample of 7 ml collected from people coming to donate blood at thethe French Blood Establishment of Martinique.\n\nThe volume does not exceed the maximum amount allowed by French regulations for blood donation.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-07', 'studyFirstSubmitDate': '2010-07-05', 'studyFirstSubmitQcDate': '2010-07-06', 'lastUpdatePostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of hydrolase and DNase activities', 'timeFrame': '2 years', 'description': 'Estimate the presence of a significant enzymatic activity by calculating the frequency of the hydrolase and DNase activities in lupus in Martinique(French west-indies)'}], 'secondaryOutcomes': [{'measure': 'Association of disease activity and catalytic activity', 'timeFrame': '2 years', 'description': 'Evaluate the strength of the association of disease activity and catalytic activity of antibodies (quiescent / active and control / patient)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Systemic Lupus Erythematosus in Martinique', 'Hydrolase and DNase activities'], 'conditions': ['Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': '* The Martinique island (French West-Indies) is an area of high prevalence and incidence for Systemic Lupus Erythematosus (SLE), respectively 64,2/ 100000 and 4,7/ 100000. In many cases, this disease concerns Afro Caribbean women, whose auto-antibodies are excessively high; also, organic damages are frequent. The disease can be fatal.\n* Studies have shown that some cytotoxic auto-antibodies may have a responsibility in the hydrolysing of DNA. This study will focus on the DNA activity and also on the overwhelm hydrolase activity dealing with the Lupus disease in order to measure the link between the disease activity and the catalytic activity. Patients concerned by this study will be Martinique people.', 'detailedDescription': 'This study will be conducted as an case-control survey.\n\n* The first group with patients: 60 SLE patients, 30 patients with a quiescent lupus and 30 patients with an active lupus. Patients that will be included are followed by the University hospital of Fort-de-France.\n* The second group is the control group: subjects will be recruited by the French organisation responsible for donation of blood.\n\nTest will be done at the UMRS 872 laboratory of the INSERM - Laboratory of Immunopathology and Therapeutic immunointervention - in Paris ; two catalytic activities will be tested: the DNase activity and the hydrolase activity.\n\nMeans to analyse the two activities: digestion of plasmid and Affinity-linked Oligonucleotide Nuclease Assay for DNase activity and hydrolysis of a peptide PFR-MCA for hydrolase activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cases are patients with Systemic Lupus Erythematosus treated at the Centre Hospitalier of Fort de France (Martinique): patients with a quiescent lupus and patients with an active lupus.\n\nControles are people coming to donate blood samples at the French Blood Establishment of Martinique.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor patients:\n\n* Presence of systemic lupus erythematosus according to the criteria of the modified 1997 ARA 1982 Lupus systemic evolution: Rates of anti DNA\\> 100 U/L in ELISA and SLEDAI\\> 7. Quiescent systemic Lupus: SLEDAI \\<7\n* Be aged 18 years and over\n* Patient who has his main home in Martinique\n* Patient who gave his agreement to participate in this clinical study\n\nFor control subjects:\n\n* Voluntary donor who gave freely his agreement to participate in this study\n* Be aged 18 years and over\n* Patient who has his main home in Martinique\n* Voluntary who gave his agreement to participate in this clinical study\n\nExclusion Criteria:\n\nFor patients:\n\n* Presence of mixed connective tissue disease, Hashimoto\n* Patients with other diseases: cancer, current infection\n* Patient pregnant or breast-feeding\n* Patient who refuse to participate in the study\n* Patient not affiliated with a social security scheme (beneficiary or beneficiary)\n* Specially Protected Persons (or under guardianship)\n* Patient who has not his main home in Martinique\n\nFor control subjects:\n\n* Voluntary donor who refused to participate in this study\n* Voluntary who has not main home in Martinique'}, 'identificationModule': {'nctId': 'NCT01157468', 'acronym': 'LUMAB2', 'briefTitle': 'Catalytic Antibodies and Lupus in Martinique', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Center of Martinique'}, 'officialTitle': 'Study of Catalytic Antibodies in a Cohort Population of Martinique', 'orgStudyIdInfo': {'id': '10/E/12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'The "Case" group is constituted with patients with Systemic Lupus Erythematosus from Martinique, divided en 2:\n\n* 30 patients with a quiescent lupus\n* 30 patients with an active lupus'}, {'label': 'Controles', 'description': 'The "Control" group is constituted by people coming to give blood to the French Blood Establishment of Martinique.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97261', 'city': 'Fort de France', 'state': 'Martinique', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Fort de France'}], 'overallOfficials': [{'name': 'Christophe DELIGNY, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Médecine Interne - Centre Hospitalier Universiatire de Fort de France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Center of Martinique', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}