Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-10
Brief Title:
Systemic Lupus Erythematosus and Chlordecone Impregnation in Martinique
Sponsor:
University Hospital Center of Martinique
Organization:
University Hospital Center of Martinique
Study Overview
Official Title:
Systemic Lupus Erythematosus and Chlordecone Impregnation in Martinique
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LUNEK
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 05 gg or 24-hour proteinuria greater than 05g
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
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 05 gg or 24-hour proteinuria greater than 05g
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None