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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07411651
Acronym
EXPOSAL
Enrollment
42
Registered
2026-02-17
Start date
2026-06-01
Completion date
2027-02-01
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Breast Lesions, Endocrine Disruptors, Metabolomics

Brief summary

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

OTHERCollection of biological and clinical data

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

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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)J1 - The day of the surgeryTo 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

Secondary

MeasureTime frameDescription
Carrying out a metabolomics approach on breast adipose tissue samples to determine biomarkers of biological response to endocrine disruptors exposureJ1 - the day of the surgeryMass spectrometry (GC-MS/MS and LC-MS/MS) on samples of breast adipose tissue

Countries

France

Contacts

CONTACTGuillaume Binson, PharmD, PhD
guillaume.binson@chu-poitiers.fr+33 (5) 49 44 44 44
CONTACTNicolas Venisse, PharmD, PhD
STUDY_DIRECTORGuillaume Binson, PharmD, PhD

Poitiers University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026