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

Обзор

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.

Вмешательства

• Другое Collection of biological and clinical data
  Collection of biological samples (hair, urine, breast adipose tissue) Collection of clinical and paraclinical data

Первичные конечные точки

• 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) [Срок оценки: J1 - The day of the surgery]

Вторичные конечные точки (1)

• Carrying out a metabolomics approach on breast adipose tissue samples to determine biomarkers of biological response to endocrine disruptors exposure [Срок оценки: J1 - the day of the surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Poitiers University Hospital — Poitiers

Идентификаторы

NCT: NCT07411651 · 2024-A01658-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗