Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2026-01-03 @ 8:40 PM
Study NCT ID:
NCT02890095
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-07
First Post:
2016-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Persistent Organic Pollutants and Breast Cancers (POPCASE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019651', 'term': 'Plastic Surgery Procedures'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 769}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2034-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-05', 'studyFirstSubmitDate': '2016-08-31', 'studyFirstSubmitQcDate': '2016-08-31', 'lastUpdatePostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation between the individual risk of breast cancer and persistent chemical contaminants', 'timeFrame': '10 years after surgery', 'description': 'The main objective is to establish a correlation between the individual risk of breast cancer and persistent chemical contaminants (POPs) respectively measured in adipose tissue (i.e. storage compartment) and blood (i.e. circulating compartment).\n\n=\\> Comparison of the assay in the body of a set of chemical pollutants in the environment between the following two groups:\n\n* Group A: women receiving breast cancer surgery,\n* Group B: women receiving breast surgery for the purpose of plastic surgery (control) This contamination profile is "exposure of interest" in this study. The quantification of this exposure is based on a targeted measure, by mass spectrometry, an expanded set of representative substances of the main families of lipophilic POPs (pesticides, PCBs, dioxins and polybrominated compounds) present to trace (femtomol).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Exposure to certain classes of chemical contaminants, including certain persistent organic pollutants (POPs) with a character of endocrine disruptors, could be one of the factors that lead to increase incidence of breast cancer in the Western world .\n\nHowever, the causal role of POPs in the onset of breast cancer remains nowadays unproven. Preliminary epidemiological studies on the impact of these environmental factors in breast cancer etiology have ignored the critical periods of exposure. Similarly, they have considered a limited number of pollutants (not including possible joint or synergistic effects between individual compounds) and did not distinguish the different breast cancer subtypes may have different etiologies or even of genetic susceptibility factors (POP polymorphism of detoxification enzymes).\n\nThus, POPCASE study examines the association between the presence of breast cancer and the levels and exposure profiles to a group of POPs measured in adipose tissue (AT) and blood, in particular using spectrometric methods developed by the team LABERCA (Nantes, France). These internal levels of POPs (organochlorine pesticides, dioxins, PCBs, brominated flame retardants) will be measured both quantitatively (tissue concentrations) and qualitative (relative proportions of different pollutants sought).', 'detailedDescription': 'Exposure to certain classes of chemical contaminants, including certain persistent organic pollutants (POPs) with a character of endocrine disruptors, could be one of the factors that lead to increase incidence of breast cancer in the Western world .\n\nHowever, the causal role of POPs in the onset of breast cancer remains nowadays unproven. Preliminary epidemiological studies on the impact of these environmental factors in breast cancer etiology have ignored the critical periods of exposure. Similarly, they have considered a limited number of pollutants (not including possible joint or synergistic effects between individual compounds) and did not distinguish the different breast cancer subtypes may have different etiologies or even of genetic susceptibility factors (POP polymorphism of detoxification enzymes).\n\nFinally, this demonstration has not been done for 2 reasons:\n\n* Multidisciplinary Issues,\n* Need innovative tools for statistical analysis and interpretation of these more integrated environmental data.\n\nThus, POPCASE study examines the association between the presence of breast cancer and the levels and exposure profiles to a group of POPs measured in adipose tissue (AT) and blood, in particular using spectrometric methods developed by the team LABERCA (Nantes, France). These internal levels of POPs (organochlorine pesticides, dioxins, PCBs, brominated flame retardants) will be measured both quantitatively (tissue concentrations) and qualitative (relative proportions of different pollutants sought).\n\nIt is therefore to improve the level of knowledge between environmental chemical exposure and increased incidence of breast cancer (in its environmental, genetic and molecular components) within the general population, in response to a public health issue, the question of the actual impact on the health of major classes of chemical pollutants present in our environment and our staying power behind debates and being associated with high stakes, both scientists but economic and societal.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women ≥ 18 and \\<75 years\n2. According to the arm:\n\n * Arm A: histologically confirmed diagnosis of invasive breast cancer (only), unilateral or bilateral, outside off recurrence and relapse. Patients who have been supported for a contralateral breast cancer can be included if a period of at least 2-years between the last systemic treatment of inclusion in the study.\n * Arm B: Any woman operated on for breast plastic surgery (breast lift and breast reduction cure only)\n3. Performance status (WHO) ≤ 1\n\n5\\. Patient affiliated to a social security scheme, 6. Patient who signed and dated informed consent form 7. Arm A only: unifocal lesion 8. Arm A only: Clinical stage M0\n\nExclusion Criteria:\n\n1. Patient with uncontrolled infection\n2. Patient pregnant or lactating\n3. Patient with a viral infection (HIV, Hepatitis B, Hepatitis C)\n4. Patient cannot be regularly monitored for psychological reasons, social, family or geographical.\n5. Patient Private of liberty or under a guardianship authority / curatorship.\n6. Arm A only: Patient to benefit from neoadjuvant therapy for breast cancer\n7. Arm A only Patient with metastatic breast cancer\n8. Arm A only Patient diagnosed cancer in situ (intra ductal)\n9. Arm A only Patient with BRCA1 or BRCA2 known\n10. Arm B only: previous breast plastic surgery, regardless of the type of intervention'}, 'identificationModule': {'nctId': 'NCT02890095', 'acronym': 'POPCASE', 'briefTitle': 'Persistent Organic Pollutants and Breast Cancers (POPCASE)', 'organization': {'class': 'OTHER', 'fullName': "Institut Cancerologie de l'Ouest"}, 'officialTitle': 'Prospective, Multicenter, Epidemiological Case-control Study, to Establish a Possible Correlation Between Persistent Chemical Contaminants (POPs) and Breast Cancer.', 'orgStudyIdInfo': {'id': 'ICO-N-2014-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A = Breast Cancer surgery', 'description': 'Arm A : women undergoing breast cancer surgery.', 'interventionNames': ['Procedure: Breast cancer surgery']}, {'type': 'OTHER', 'label': 'Arm B = Control (plastic surgery)', 'description': 'Arm B : women undergoing breast surgery for the purpose of plastic surgery', 'interventionNames': ['Procedure: plastic surgery']}], 'interventions': [{'name': 'Breast cancer surgery', 'type': 'PROCEDURE', 'description': 'First, 2 specific adipose tissue samples will be performed during the surgery :\n\n* 1 sample near the tumor, to measure the contaminants (dioxins, PCBs, organochlorine pesticides, polybrominated compounds)\n* 1 remote sample of the tumor bed, superficial, at least 5 cm from the tumor, to be used to determine the level of expression of hormone receptors and to establish the expression profiles, after cutting and inclusion in paraffin blocks for marking IHC.\n\nThese withdrawals are made during surgery, during surgery, as part of the intervention and the remodeling of the mammary gland (standard care for patients). This is unused balance for diagnostic.\n\nBefore anaesthesia : specific blood samples (for the determination of circulating pollutants and for the analysis of gene polymorphism)', 'armGroupLabels': ['Arm A = Breast Cancer surgery']}, {'name': 'plastic surgery', 'type': 'PROCEDURE', 'description': 'The excision piece will follow the classical pathological circuit.\n\nA specific charge of subcutaneous adipose tissue will be performed as part of research on the surgical specimen. This sample will be used:\n\n* measuring contaminants (dioxins, PCBs, organochlorine pesticides, polybrominated compounds)\n* to determine the level of expression of hormone receptors and to establish the expression profiles, after cutting and inclusion in paraffin blocks for marking IHC. These samples are all made during surgery, for usual care surgery these patients.\n\nBefore anaesthesia : specific blood samples (for the determination of circulating pollutants and for the analysis of gene polymorphism)', 'armGroupLabels': ['Arm B = Control (plastic surgery)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44046', 'city': 'Nantes', 'country': 'France', 'facility': 'Clinique Breteche', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'ICO René Gauducheau', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Mario CAMPONE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut de Cancérologie de l'Ouest"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Cancerologie de l'Ouest", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}