Confirmation of the Link Between Endocrine Disruptors Exposure and Breast Cancer and Identification of Biological Response Biomarkers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Collection of biological and clinical data.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Endocrine Disruptors, Metabolomics, Breast Lesions. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Collection of biological and clinical data
Collection of biological samples (hair, urine, breast adipose tissue) Collection of clinical and paraclinical data
Primary outcome measures
- 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) [Time frame: J1 - The day of the surgery]
Secondary outcome measures (1)
- Carrying out a metabolomics approach on breast adipose tissue samples to determine biomarkers of biological response to endocrine disruptors exposure [Time frame: J1 - the day of the surgery]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Poitiers University Hospital — Poitiers
Identifiers
NCT: NCT07411651 · 2024-A01658-39