跳至主要内容
临床试验/NCT07251036
NCT07251036招募中不适用

Serum Chordecone Concentration in Guadeloupean Population: Impact of a Multidisciplinary Support Program on the Reduction of the Contamination Level.

Centre Hospitalier Universitaire de la Guadeloupe1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2022年6月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
3,000
试验地点
1
主要终点
chlordecone level

研究概览

简要总结

The French West Indies (Guadeloupe, Martinique) are characterized by a major use of pesticides in bananas plantation from the 1950s. These crops used organochlorine insecticides and especially chlordecone (CLD) from 1972 to 1993. The lack of biotic and abiotic degradation of CLD led to persistent soil pollution, contamination of surface and deep waters, of numerous plant and animal, and of the population. The extent and persistence of CLD contamination over time is a major issue for these territories. An internal reference value (0.4μg/l) was recently determined. Although useful for a population approach, it must be used with caution for the interpretation of an individual result. In response to the strong social demand expressed by the population for access to free chlordecone blood tests, a screening program for blood chlordecone test was authorized by the 2019 French Finance Act.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Refusal to participate
  • Person not affiliated with a social security scheme
  • Person under legal protection (safeguard of justice, guardianship, curatorship, etc.

结局指标

主要结局

chlordecone level

时间窗: between Day0 to Day15

ug/l

risk factors

时间窗: between day 15 and day 45 ,

chlordeconemia survey

chlordecone level

时间窗: between Day0 to Day15

ug/l

risk factors

时间窗: between day 15 and day 45 ,

chlordeconemia survey

次要结局

  • chlordecone level(at delivery for pregnant women)
  • chlordecone level(At 9 months after intervention)
  • chlordecone level(At 18 months after intervention)
  • chlordecone level(at delivery for pregnant women)
  • impact of an intervention(between day 15 to day 45, at month 9 and month 18)

研究者

发起方
Centre Hospitalier Universitaire de la Guadeloupe
申办方类型
Other
责任方
Sponsor

研究点 (1)

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