- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07251036
Serum Chordecone Concentration in Guadeloupean Population: Impact of a Multidisciplinary Support Program on the Reduction of the Contamination Level. (ChlorGua)
Study Overview
Detailed Description
The target populations will receive an invitation letter with an information notice and a consent form. The referral physician will explain the program and the research project and prescribe a standardized blood sample test.
Blood samples will be taken in one of the biology laboratories participating in the project. Serum chordecone test will be performed by the Pasteur Institute of Guadeloupe. Blood samples for biological collection will be sent to the Biological Resource Center, Karubiotec™. The result of the chlordécone level will be sent back to each subject with a recommendation note based on the chlordécone level value. Phone contact information for those who consented to the study will be forwarded to the research assistant for the questionnaire.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Valérie HAMONY-SOTER
- Phone Number: +590590934686
- Email: valerie.soter@chu-guadeloupe.fr
Study Contact Backup
- Name: Eunice NUBRET
- Email: eunice.nubret@chu-guadeloupe.fr
Study Locations
-
-
Guadeloupe
-
Pointe-à-Pitre, Guadeloupe, Guadeloupe, 97159
- Recruiting
- Centre Hospitalier Universitaire de la Guadeloupe
-
Contact:
- Eunice NUBRET
- Email: eunice.nubret@chu-guadeloupe.fr
-
Contact:
- Valérie SOTER
- Phone Number: +590590934686
- Email: valerie.soter@chu-guadeloupe.fr
-
Principal Investigator:
- Jacqueline DELOUMEAUX, Doctor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
- All subject overs 18 years of age residing in Guadeloupe invited to participate to the program by the Regional Health Agency or subjects who requested a test from their doctor in the framework of the ministerial measure.
- Subjects who have read the information note and signed the consent to participate in the study
- Subjects with social security coverage
Exclusion Criteria:
- Refusal to participate
- Person not affiliated with a social security scheme
- Person under legal protection (safeguard of justice, guardianship, curatorship, etc.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: guadeloupean subject
All subject overs 18 years of age residing in Guadeloupe invited to participate to the program
|
The target populations will receive an invitation letter with an information notice and a consent form. The referral physician will explain the program and the research project and prescribe a standardized blood sample test. Blood samples will be taken in one of the biology laboratories participating in the project. Serum chordecone test will be performed by the Pasteur Institute of Guadeloupe. Blood samples for biological collection will be sent to the Biological Resource Center, Karubiotec™. The result of the chlordécone level will be sent back to each subject with a recommendation note based on the chlordécone level value. Phone contact information for |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
chlordecone level
Time Frame: between Day0 to Day15
|
ug/l
|
between Day0 to Day15
|
|
risk factors
Time Frame: between day 15 and day 45 ,
|
chlordeconemia survey
|
between day 15 and day 45 ,
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
chlordecone level
Time Frame: At 9 months after intervention
|
ug/l
|
At 9 months after intervention
|
|
chlordecone level
Time Frame: At 18 months after intervention
|
ug/l
|
At 18 months after intervention
|
|
chlordecone level
Time Frame: at delivery for pregnant women
|
ug/l
|
at delivery for pregnant women
|
|
impact of an intervention
Time Frame: between day 15 to day 45, at month 9 and month 18
|
chlordeconemia survey
|
between day 15 to day 45, at month 9 and month 18
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jacqueline DELOUMEAUX, Doctor, CHU de la Guadeloupe
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PAP_RIPH2_2022/01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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