NCT06365359 Systemic Lupus Erythematosus and Chlordecone Impregnation in Martinique
| NCT ID | NCT06365359 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Center of Martinique |
| Condition | Systemic Lupus Erythematosus |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-01-02 |
| Primary Completion | 2026-07-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-01-02 with a primary completion date of 2026-07-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. Epidemiological 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. Chlordecone 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. In 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. Chlordecone 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. The 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). The 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.
Eligibility Criteria
Inclusion Criteria: * Patients with systemic lupus erythematosus according to the ACR 1997 or ACR/EULAR 2019 criteria, * Present in the active line of the internal medicine department of the Martinique University Hospital since 2005, * Whose illness has been progressing for at least 3 years, * Living in Martinique or Guadeloupe for at least 1 year, * Patients who have given their free, informed and written consent. Exclusion Criteria: * Patients for whom kidney disease cannot be authenticated or ruled out (refusal, contraindication or impossibility of renal biopsy), * Patients without social security coverage, * Current legal protection, * Patients who have not given their consent to the use of their data, * Pregnant or breastfeeding women.
Contact & Investigator
Benoît SUZON, PhD
PRINCIPAL INVESTIGATOR
University Hospital Center of Martinique
Frequently Asked Questions
Who can join the NCT06365359 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06365359 currently recruiting?
Yes, NCT06365359 is actively recruiting participants. Contact the research team at benoit.suzon@chu-martinique.fr for enrollment information.
Where is the NCT06365359 trial being conducted?
This trial is being conducted at Fort-de-France, France.
Who is sponsoring the NCT06365359 clinical trial?
NCT06365359 is sponsored by University Hospital Center of Martinique. The principal investigator is Benoît SUZON, PhD at University Hospital Center of Martinique. The trial plans to enroll 200 participants.
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