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临床试验/NCT07411651
NCT07411651尚未招募不适用

Confirmation of the Link Between Endocrine Disruptors Exposure and Breast Cancer and Identification of Biological Response Biomarkers

Poitiers University Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
42
试验地点
1
主要终点
To determine the exposure profile to BPA and its chlorinated derivatives, BPS, BPF and parabens in women with breast lesions according to 2 profiles (cancerous and overlapping lesions and benign lesions)

研究概览

简要总结

A wide variety of chemicals are constantly being introduced in our environment. The toxicological consequences related to the exposure to these compounds and their impact on public health ar of growing concern. It is now accepted that the occurrence of some non-communicable chronic diseases (diabetes, cancer, cardiovascular diseases…) is the result of complex interactions between environmental factors (chemical, physical and biological) and genetic factors. These non-communicable diseases have significantly increased in recent decades et have become the world's leading cause of deaths. Among these environmental factors, and in particular chemicals, the class of endocrine disruptors (EDs) is of particular concern. EDs are found ubiquitously in our environment. They are found in the natural environment (water, air, soil, etc.) as well as in everyday objects and our food. As a result, the general population is widely exposed to these EDs, which can be measured in a variety of biological media. The collection of biological matrices is essential for studying the exposure of populations to EDs. The choice of biological matrices depends on the physicochemical characteristics of the EDs studied and the type of exposure being assessed. Internal exposure to EDs is most often assessed through blood or urine concentrations in spot samples. Measuring urinary EDs concentrations remains a reference method for biomonitoring bisphenols and parabens. In order to assess long-term exposure to EDs, it was proposed to determine EDs concentrations in hair. In addition to these biological matrices for assessing general short-term and long-term exposure, the use of breast adipose tissue will enable in situ assessment of EDs exposure in the patients included. Moreover, adipose tissue represents an interesting biological matrix for determining exposure to pollutants with short half-lives, such as bisphenols and parabens, particularly when the latter have lipophilic characteristics. In addition, the use of this matrix will enable a non-targeted metabolomics approach to identify possible markers of biological response to EDs exposure, and to determine links between this exposure and carcinogenesis processes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Age ≥ 18 years
  • Female sex
  • Patient with scheduled surgical procedure for removal of a breast lesion
  • Patient who was informed by the surgeon at the preoperative consultation and having signed the consent form
  • Free subject, without guardianship, curatorship or subordination
  • Patients benefiting from a social security scheme or benefiting from such a scheme through a third party

排除标准

  • Persons benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by judicial or administrative decision, people staying in a health or social establishment, adults under legal protection and patients in emergency situations
  • Pregnant or breast-feeding women.

研究组 & 干预措施

Cancerous or overlapping breast lesion

Other

Patients with cancerous lesion or overlapping breast lesion based on anatomopathological data

干预措施: Collection of biological and clinical data (Other)

Benign breast lesion

Other

Patients with benign breast lesion based on anatomopathological data

干预措施: Collection of biological and clinical data (Other)

结局指标

主要结局

To determine the exposure profile to BPA and its chlorinated derivatives, BPS, BPF and parabens in women with breast lesions according to 2 profiles (cancerous and overlapping lesions and benign lesions)

时间窗: J1 - The day of the surgery

To mesure exposure profil based of concentrations of BPA and chlorinated derivatives, BPS, BPF, parabens (methyl-, ethyl-, propyl-, and butylparaben) in several biological matrices (UHPLC-MS/MS): * Breast adipose tissue: assessment of in situ exposure as close as possible to the breast lesion * Urine: assessment of short-term exposure * Hair: assessment of long-term exposure

次要结局

  • Carrying out a metabolomics approach on breast adipose tissue samples to determine biomarkers of biological response to endocrine disruptors exposure(J1 - the day of the surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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