Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-29 @ 7:47 AM
Study NCT ID:
NCT06365359
Status:
RECRUITING
Last Update Posted:
2025-03-31
First Post:
2024-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systemic Lupus Erythematosus and Chlordecone Impregnation in Martinique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], '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'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital 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_WITHOUT_DNA', 'description': 'Blood cell collection'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-09-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2024-04-10', 'studyFirstSubmitQcDate': '2024-04-10', 'lastUpdatePostDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To estimate the risk of presenting a renal complication of lupus disease based on the level of impregnation with chlordecone in the lupus patients seen at the Martinique University Hospital.', 'timeFrame': '18 months', 'description': 'Calculation of the Odds ratio (OR) of having lupus kidney disease according to the plasma chlordecone concentration at baseline.\n\nPatients classified "M+ = Suffering from lupus kidney disease" will be those for whom the diagnosis was suspected based on a proteinuria to creatininuria ratio greater than 0.5 g/g (or 24-hour proteinuria greater than 0.5g) and confirmed by a kidney biopsy which allows the formal diagnosis of lupus kidney damage, but also its categorization into several classes, depending on the cell proliferation observed.\n\nThe biomarker of exposure to chlordecone will, at a minimum, be dichotomized into two classes according to the median value of the distribution of plasma chlordecone concentration (E-/E+).'}], 'secondaryOutcomes': [{'measure': 'To compare the activity of lupus according to the level of impregnation with chlordecone.', 'timeFrame': '18 months', 'description': 'Average of SELENA-SLEDAI lupus activity score retrospectively assessed from diagnosis to patient inclusion + number of disease flares since the first diagnostic flare.'}, {'measure': 'To compare the after-effects of lupus according to the level of impregnation with chlordecone.', 'timeFrame': '18 months', 'description': 'SLICC/SDI lupus after-effects score in the retrospective analysis of the history of the disease.'}, {'measure': 'To describe the distribution of the plasma concentration of chlordecone in lupus patients followed by the internal medicine department of the Martinique University Hospital.', 'timeFrame': '18 months', 'description': "Distribution of plasma chlordecone concentration and of other organochlorine compounds such as: p,p'-DDE, βHCH, γHCH, PCB 153."}, {'measure': "To describe the distribution of the plasma concentration of p,p'-DDE in lupus patients followed by the internal medicine department of the Martinique University Hospital.", 'timeFrame': '18 months', 'description': "Distribution of plasma p,p'-DDE concentration"}, {'measure': 'To describe the distribution of the plasma concentration of βHCH in lupus patients followed by the internal medicine department of the Martinique University Hospital.', 'timeFrame': '18 months', 'description': 'Distribution of plasma βHCH concentration'}, {'measure': 'To describe the distribution of the plasma concentration of γHCH in lupus patients followed by the internal medicine department of the Martinique University Hospital.', 'timeFrame': '18 months', 'description': 'Distribution of plasma γHCH concentration'}, {'measure': 'To describe the distribution of the plasma concentration of PCB 153 in lupus patients followed by the internal medicine department of the Martinique University Hospital.', 'timeFrame': '18 months', 'description': 'Distribution of plasma PCB 153 concentration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Systemic Lupus Erythematosus', 'Chlordecone impregnation', "Organochlorine pesticide (chlordecone, p,p'-DDE, βHCH, γHCH, PCB 153)", 'Renal Disease'], 'conditions': ['Systemic Lupus Erythematosus', 'Renal Disease']}, 'descriptionModule': {'briefSummary': 'Chlordecone, an organochlorine pesticide, was widely used on banana farms in the French West Indies. Studies by Inserm and health authorities have confirmed the contamination of the food chain and the majority of the population of the French West Indies by chlordecone.\n\nEpidemiological studies conducted in the French West Indies have shown that exposure to chlordecone at the levels observed is associated with an increased risk of developing several diseases, including premature birth and prostate cancer. Many of the adverse effects associated with chlordecone could be explained by its estrogenic hormonal properties, and systemic lupus erythematosus (SLE) is an autoimmune disease whose sensitivity to estrogen is well known and is reflected by 1) its clear predominance in women, 2) its predominance in women of childbearing age, 3) its risk of exacerbation in the event of pregnancy.\n\nChlordecone has the potential to modify the activity of SLE through mechanisms other than its pro-estrogenic effects. In rats, chlordecone was observed to induce alterations such as a reduction in lymphocyte count, thymic atrophy, and a decrease in splenic germinal centers and NK cells.\n\nIn a mouse model of systemic lupus erythematosus (SLE), exposure to chlordecone results in increased production of immune complexes and anti-DNA antibodies, which are markers of disease activity and monitoring.\n\nChlordecone also has a cellular effect that reduces the apoptosis of potentially auto-reactive lymphocytes and stimulates the production of GM-CSF, IL-2, TNF-alpha, and IFN-gamma. The latter is central to the pathophysiology of SLE. While experimental studies suggest a potential impact of chlordecone on SLE, no human studies have been conducted to date, and the chlordecone impregnation of lupus patients in Martinique remains unknown.\n\nThe most serious and feared complication of SLE is kidney damage. Kidney damage from the disease and the necessary immunosuppressive treatments can lead to significant morbidity and mortality, including death and end-stage chronic renal failure. Therefore, it is important to manage the disease carefully. Suspected lupus nephritis is confirmed by a renal biopsy, which allows for formal diagnosis and categorization into several classes. Suspected cases are identified by a proteinuria to creatininuria ratio greater than 0.5 g/g (or 24-hour proteinuria greater than 0.5g).\n\nThe objective of this project is to determine whether there is a positive association between lupus nephritis occurrence in patients followed by the internal medicine department of the Martinique University Hospital and organochlorine pesticide chlordecone impregnation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with systemic lupus erythematosus according to the ACR 1997 or ACR/EULAR 2019 criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with systemic lupus erythematosus according to the ACR 1997 or ACR/EULAR 2019 criteria,\n* Present in the active line of the internal medicine department of the Martinique University Hospital since 2005,\n* Whose illness has been progressing for at least 3 years,\n* Living in Martinique or Guadeloupe for at least 1 year,\n* Patients who have given their free, informed and written consent.\n\nExclusion Criteria:\n\n* Patients for whom kidney disease cannot be authenticated or ruled out (refusal, contraindication or impossibility of renal biopsy),\n* Patients without social security coverage,\n* Current legal protection,\n* Patients who have not given their consent to the use of their data,\n* Pregnant or breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT06365359', 'acronym': 'LUNEK', 'briefTitle': 'Systemic Lupus Erythematosus and Chlordecone Impregnation in Martinique', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Center of Martinique'}, 'officialTitle': 'Systemic Lupus Erythematosus and Chlordecone Impregnation in Martinique', 'orgStudyIdInfo': {'id': '23_RIPH2-12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lupus patients who consult the Martinique University Hospital', 'interventionNames': ['Other: Blood sample for analysis of plasma of organochlorine pesticides concentration', 'Other: Blood sample for cell collection']}], 'interventions': [{'name': 'Blood sample for analysis of plasma of organochlorine pesticides concentration', 'type': 'OTHER', 'description': "A 20 mL blood sample will be taken up to 6 months after inclusion of the patient for the analysis of chlordecone and the following organochlorine compounds: p,p'-DDE, βHCH, γHCH, PCB 153. This analysis will be carried out at the Institut Pasteur of Guadeloupe (IPG).", 'armGroupLabels': ['Lupus patients who consult the Martinique University Hospital']}, {'name': 'Blood sample for cell collection', 'type': 'OTHER', 'description': 'A 20 mL blood sample will be taken up to 6 months after inclusion of the patient for the cell collection which will be kept at the CeRBiM.\n\nThis collection will be used for subsequent studies on the immunotoxicity of chlordecone, by studying the cytokine, apoptotic and autoreactive functions of PBMC (Peripheral Blood Mononuclear Cells).', 'armGroupLabels': ['Lupus patients who consult the Martinique University Hospital']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97261', 'city': 'Fort-de-France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yann MOPSUS, MSc', 'role': 'CONTACT', 'email': 'yann.mopsus@chu-martinique.fr'}, {'name': 'Benoît SUZON, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Center of Martinique'}], 'centralContacts': [{'name': 'Benoît SUZON, PhD', 'role': 'CONTACT', 'email': 'benoit.suzon@chu-martinique.fr', 'phone': '05 96 55 97 05', 'phoneExt': '+596'}], 'overallOfficials': [{'name': 'Benoît SUZON, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Center of Martinique'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Center of Martinique', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut Pasteur de Guadeloupe', 'class': 'UNKNOWN'}, {'name': 'Centre de Ressources Biologiques de la Martinique (CeRBiM)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}