NCT06365359: LUNEK

Systemic Lupus Erythematosus and Chlordecone Impregnation in Martinique

Recruiting now Last updated 31 March 2025

What this trial tests

trial testing Blood sample for analysis of plasma of organochlorine pesticides concentration in Systemic Lupus Erythematosus in 200 participants. Currently enrolling.

Timeline

2 January 2025

Primary endpoint
2 July 2026

2 September 2026

Quick facts

Lead sponsor	University Hospital Center of Martinique
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	200
Start date	2 January 2025
Primary completion	2 July 2026
Estimated completion	2 September 2026
Sites	1 location across France

Drugs / interventions tested

• Blood sample for analysis of plasma of organochlorine pesticides concentration
• Blood sample for cell collection

Conditions studied

• Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →
• Renal Disease — all drugs for Renal Disease →

Sponsor

University Hospital Center of Martinique

Who can join

18 and older, any sex, with Systemic Lupus Erythematosus or Renal Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.