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

February 6, 2026 updated by: Poitiers University Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Nicolas Venisse, PharmD, PhD

Study Locations

  • France
      • Poitiers, France, 86021
        • Poitiers University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cancerous or overlapping breast lesion
Patients with cancerous lesion or overlapping breast lesion based on anatomopathological data
Other: Collection of biological and clinical data
Collection of biological samples (hair, urine, breast adipose tissue) Collection of clinical and paraclinical data
Other: Benign breast lesion
Patients with benign breast lesion based on anatomopathological data
Other: Collection of biological and clinical data
Collection of biological samples (hair, urine, breast adipose tissue) Collection of clinical and paraclinical data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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
J1 - The day of the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Mass spectrometry (GC-MS/MS and LC-MS/MS) on samples of breast adipose tissue
J1 - the day of the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Investigators

  • Study Director: Guillaume Binson, PharmD, PhD, Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A01658-39

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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