Systemic Lupus ErythematosusLUNEKNCT06365359
Systemic Lupus Erythematosus and Chlordecone Impregnation in Martinique
An observational study of Systemic Lupus Erythematosus and Renal Disease, run by University Hospital Center of Martinique at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Renal Disease
- What is being tested?
- Blood sample for analysis of plasma of organochlorine pesticides concentration and Blood sample for cell collection
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2025to 2 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with systemic lupus erythematosus according to the ACR 1997 or ACR/EULAR 2019 criteria
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital Center of Martinique
Fort-de-France, 97261
Yann MOPSUS, MSc, yann.mopsus@chu-martinique.fr
Benoît SUZON, PhD
About this study
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.
Read more
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.
- Conditions
- Systemic Lupus Erythematosus, Renal Disease
- Being tested
- Blood sample for analysis of plasma of organochlorine pesticides concentration, Blood sample for cell collection
- Keywords
- Systemic Lupus Erythematosus, Chlordecone impregnation, Organochlorine pesticide (chlordecone, p,p'-DDE, βHCH, γHCH, PCB 153), Renal Disease
- Medical subject headings
- Lupus Erythematosus, Systemic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample for analysis of plasma of organochlorine pesticides concentrationOther
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).
Blood sample for cell collectionOther
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.
This 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).
| Study group | Role | What they receive |
|---|---|---|
| Lupus patients who consult the Martinique University Hospital | Not described Receives: Other: Blood sample for analysis of plasma of organochlorine pesticides concentration; Other: Blood sample for cell collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Calculation of the Odds ratio (OR) of having lupus kidney disease according to the plasma chlordecone concentration at baseline.
Patients 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.
The 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+).
Measured: 18 months
Secondary outcomes (7)
To compare the activity of lupus according to the level of impregnation with chlordecone.
Average of SELENA-SLEDAI lupus activity score retrospectively assessed from diagnosis to patient inclusion + number of disease flares since the first diagnostic flare.
Measured: 18 months
To compare the after-effects of lupus according to the level of impregnation with chlordecone.
SLICC/SDI lupus after-effects score in the retrospective analysis of the history of the disease.
Measured: 18 months
To describe the distribution of the plasma concentration of chlordecone in lupus patients followed by the internal medicine department of the Martinique University Hospital.
Distribution of plasma chlordecone concentration and of other organochlorine compounds such as: p,p'-DDE, βHCH, γHCH, PCB 153.
Measured: 18 months
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.
Distribution of plasma p,p'-DDE concentration
Measured: 18 months
To describe the distribution of the plasma concentration of βHCH in lupus patients followed by the internal medicine department of the Martinique University Hospital.
Distribution of plasma βHCH concentration
Measured: 18 months
To describe the distribution of the plasma concentration of γHCH in lupus patients followed by the internal medicine department of the Martinique University Hospital.
Distribution of plasma γHCH concentration
Measured: 18 months
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.
Distribution of plasma PCB 153 concentration
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start2 Jan 2025
- Primary completion2 Jul 2026 (estimated)
- Study completion2 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur de Guadeloupe, Centre de Ressources Biologiques de la Martinique (CeRBiM)
- Responsible party
- Sponsor
- Investigators
- Benoît SUZON, PhD, Principal investigator, University Hospital Center of Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365359
- Sponsor's protocol ID
- 23_RIPH2-12
- Acronym
- LUNEK
- Status last verified
- Mar 2025
- First submitted
- 10 Apr 2024
- Last updated
- 31 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Lupus Erythematosus and Chlordecone Impregnation in Martinique
- ClinicalTrials.gov ID
- NCT06365359
- Acronym / sponsor ID
- LUNEK / 23_RIPH2-12
- Conditions
- Systemic Lupus Erythematosus, Renal Disease
- Keywords
- Systemic Lupus Erythematosus, Chlordecone impregnation, Organochlorine pesticide (chlordecone, p,p'-DDE, βHCH, γHCH, PCB 153), Renal Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- Institut Pasteur de Guadeloupe, Centre de Ressources Biologiques de la Martinique (CeRBiM)
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 2 Jul 2026 (estimated)
- Study completion
- 2 Sep 2026 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lupus patients who consult the Martinique University Hospital | – | Other: Blood sample for analysis of plasma of organochlorine pesticides concentration, Other: Blood sample for cell collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with systemic lupus erythematosus according to the ACR 1997 or ACR/EULAR 2019 criteria
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample for analysis of plasma of organochlorine pesticides concentrationA 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). | Other | Lupus patients who consult the Martinique University Hospital |
| Blood sample for cell collectionA 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. This 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). | Other | Lupus patients who consult the Martinique University Hospital |
Primary outcome
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.
Time frame: 18 months
Calculation of the Odds ratio (OR) of having lupus kidney disease according to the plasma chlordecone concentration at baseline. Patients 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. The 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+).
7 secondary outcomes
To compare the activity of lupus according to the level of impregnation with chlordecone.
Time frame: 18 months
To compare the after-effects of lupus according to the level of impregnation with chlordecone.
Time frame: 18 months
To describe the distribution of the plasma concentration of chlordecone in lupus patients followed by the internal medicine department of the Martinique University Hospital.
Time frame: 18 months
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.
Time frame: 18 months
To describe the distribution of the plasma concentration of βHCH in lupus patients followed by the internal medicine department of the Martinique University Hospital.
Time frame: 18 months
To describe the distribution of the plasma concentration of γHCH in lupus patients followed by the internal medicine department of the Martinique University Hospital.
Time frame: 18 months
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.
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benoît SUZON, PhD principal investigator
University Hospital Center of Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus and Renal Disease, run by University Hospital Center of Martinique at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benoît SUZON, PhD (05 96 55 97 05 ext. +596, benoit.suzon@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2025.