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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPoitiers University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Collection of biological and clinical data

    Other intervention

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

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Cancerous or overlapping breast lesionOther 1 intervention
Group B: Benign breast lesionOther 1 intervention

Trial outcomes

Primary outcomes

1

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)

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

Time frame
J1 - The day of the surgery

Secondary outcomes

1

Carrying out a metabolomics approach on breast adipose tissue samples to determine biomarkers of biological response to endocrine disruptors exposure

Mass spectrometry (GC-MS/MS and LC-MS/MS) on samples of breast adipose tissue

Time frame
J1 - the day of the surgery

Other outcomes

Sponsors and contacts

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