Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:46 AM
Study NCT ID:
NCT07411651
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2025-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Confirmation of the Link Between Endocrine Disruptors Exposure and Breast Cancer and Identification of Biological Response Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-06', 'studyFirstSubmitDate': '2025-04-14', 'studyFirstSubmitQcDate': '2026-02-06', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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)', 'timeFrame': 'J1 - The day of the surgery', 'description': '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):\n\n* Breast adipose tissue: assessment of in situ exposure as close as possible to the breast lesion\n* Urine: assessment of short-term exposure\n* Hair: assessment of long-term exposure'}], 'secondaryOutcomes': [{'measure': 'Carrying out a metabolomics approach on breast adipose tissue samples to determine biomarkers of biological response to endocrine disruptors exposure', 'timeFrame': 'J1 - the day of the surgery', 'description': 'Mass spectrometry (GC-MS/MS and LC-MS/MS) on samples of breast adipose tissue'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Endocrine Disruptors', 'Metabolomics', 'Breast Lesions']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Female sex\n* Patient with scheduled surgical procedure for removal of a breast lesion\n* Patient who was informed by the surgeon at the preoperative consultation and having signed the consent form\n* Free subject, without guardianship, curatorship or subordination\n* Patients benefiting from a social security scheme or benefiting from such a scheme through a third party\n\nExclusion Criteria:\n\n* 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\n* Pregnant or breast-feeding women.'}, 'identificationModule': {'nctId': 'NCT07411651', 'acronym': 'EXPOSAL', 'briefTitle': 'Confirmation of the Link Between Endocrine Disruptors Exposure and Breast Cancer and Identification of Biological Response Biomarkers', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Confirmation of the Link Between Endocrine Disruptors Exposure and Breast Cancer and Identification of Biological Response Biomarkers', 'orgStudyIdInfo': {'id': '2024-A01658-39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cancerous or overlapping breast lesion', 'description': 'Patients with cancerous lesion or overlapping breast lesion based on anatomopathological data', 'interventionNames': ['Other: Collection of biological and clinical data']}, {'type': 'OTHER', 'label': 'Benign breast lesion', 'description': 'Patients with benign breast lesion based on anatomopathological data', 'interventionNames': ['Other: Collection of biological and clinical data']}], 'interventions': [{'name': 'Collection of biological and clinical data', 'type': 'OTHER', 'description': 'Collection of biological samples (hair, urine, breast adipose tissue) Collection of clinical and paraclinical data', 'armGroupLabels': ['Benign breast lesion', 'Cancerous or overlapping breast lesion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Poitiers University Hospital', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'centralContacts': [{'name': 'Guillaume Binson, PharmD, PhD', 'role': 'CONTACT', 'email': 'guillaume.binson@chu-poitiers.fr', 'phone': '+33 (5) 49 44 44 44'}, {'name': 'Nicolas Venisse, PharmD, PhD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Guillaume Binson, PharmD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Poitiers University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}