Exposure to Organochlorine Pollutants and Impact on Development in the Peripubertal Age in Guadeloupe

NCT06653660 | Recruiting

• 1 other identifier: PAP_RI2_2019/11
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

In the context of environmental pollution of the French West Indies by chlordecone and questions about health consequences, monitoring at the peripubertal age of children born alive in the TIMOUN cohort is justified in several respects: - existence of an already established mother-child cohort whose live-born children will reach peripubertal ages during the period 2020-2022; - opportunity to verify hypotheses put forward on the basis of toxicological data acquired in laboratory animals and the hormonal characteristics of chlordecone (endocrine disruptor); - strong societal demand for such research to be carried out because of concerns about the sensitivity of children and adolescents to the effects of environmental xenobiotics, in particular on sexual development and the age of puberty; - recommendation of the Scientific Council Chlordecone Inserm - InVS; specific action of the National Plan Chlordecone IV.

Conditions

Prenatal Exposure; Postnatal Exposure

Keywords

Prenatal Exposure; Postnatal Exposure; Chlordecone; Persistent Organic Pollutants; Endocrine disruptors; Puberty; Development; Guadeloupe; French West Indies

Outcome Measures

Primary Outcomes (1)

• Scores from cognitive development tests estimating verbal comprehension verbal comprehension, perceptual reasoning and working memory

  : Cognitive tests (25 min for the 3 Wechsler Intelligence Scale for Children V subscales). The Wechsler Intelligence Scale for Children-V is the most scientifically valid intelligence test for children and adolescents. It can be used to determine a child's or teenager's intelligence quotient (IQ), to obtain their complete cognitive profile and the level of the 5 main components of cognitive intelligence

  At the start of the study (inclusion visit)

Secondary Outcomes (1)

• Age at onset of pubertal development (onset of accelerated growth acceleration of growth rate, modeled on growth curves)

  At the start of the study (inclusion visit).

Other Outcomes (4)

• Age at established puberty (period for girls, molting for boys)

  At the start of the study (inclusion visit) or through study completion, an average of two years, for girls who had their period and boys molted.

• Plasma concentrations of steroid hormones

  At the start of the study (inclusion visit).

• Blood pressure

  At the start of the study (inclusion visit).

Study Arms (1)

peripubertal children

Children born from a mother whose pregnancy was included in the Timoun cohort (2004 -2007).

Other: Clinical examination

Interventions

Clinical examination OTHER

For the aim of the present study, we will follow-up children born alive in the TIMOUN cohort at peripubertal age. Questionnaires will be administered to parents on the child's health and lifestyle. Stature-weight anthropometric and cardio-dynamic measurements of the child will be obtained. Scores on three cognitive tests will be obtained. Furthermore, steroid hormones and chlordecone in the child's peripheral blood will be determined.

Also known as: Blood collection,, cognitive tests

peripubertal children

Eligibility Criteria

• Age: 16 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Be born to a mother whose pregnancy was included in the Timoun cohort (2004 - 2007)

You may qualify if:

• Be born to a mother whose pregnancy was included in the Timoun cohort (2004 - 2007) and whose parents agreed to be contacted later.
• Residing in Guadeloupe at the peripubertal age
• Affiliation to a social security scheme
• Agreement to participate in the study and informed consent signed by the minor
• Study participation agreement and informed consent signed by the parents

You may not qualify if:

• Refusal to participate in the research

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

CHU of Guadeloupe

Pointe-à-Pitre, Guadeloupe, 97159, Guadeloupe

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

samples

MeSH Terms

Interventions

Restraint, Physical; Blood Specimen Collection; Neuropsychological Tests

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Gulen AYHAN

  CHU of Guadeloupe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie HAMONY-SOTER

CONTACT

+590 590 93 46 77; valerie.soter@chu-guadeloupe.fr

Eunice NUBRET

CONTACT

+590 590 93 46 86; eunice.nubret@chu-guadeloupe.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: October 22, 2024
• Study Start: December 19, 2022
• Primary Completion (Estimated): December 19, 2026
• Study Completion (Estimated): December 19, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

GU (1)