Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-06 @ 6:47 PM
Study NCT ID:
NCT04268693
Status:
WITHDRAWN
Last Update Posted:
2022-11-17
First Post:
2020-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'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': 'D059349', 'term': 'Urine Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Study never initiated due to COVID pandemic, staffing changes', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-14', 'studyFirstSubmitDate': '2020-02-11', 'studyFirstSubmitQcDate': '2020-02-12', 'lastUpdatePostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'urinary bisphenol and phthalate metabolite levels', 'timeFrame': 'baseline', 'description': 'quantification of bisphenol and phthalate metabolites by liquid chromotography-tandem mass spectrometry'}, {'measure': 'urinary bisphenol and phthalate metabolite levels', 'timeFrame': 'post-neoadjuvant chemotherapy (either 16 or 20 weeks)', 'description': 'quantification of bisphenol and phthalate metabolites by liquid chromotography-tandem mass spectrometry'}, {'measure': 'change from baseline urinary bisphenol and phthalate levels at end of neoadjuvant chemotherapy', 'timeFrame': 'baseline and post-neoadjuvant chemotherapy (16 or 20 weeks)', 'description': 'percent of change in urinary bisphenol and phthalate levels from pre- to post-neoadjuvant chemotherapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bisphenol', 'phthalate', 'doxorubicin'], 'conditions': ['Triple Negative Breast Cancer']}, 'descriptionModule': {'briefSummary': 'In this observational pilot study urine samples will be collected from women receiving neoadjuvant chemotherapy with doxorubicin for triple negative breast cancer to determine whether: 1) exposures bisphenol and phthalate levels change over the course of neoadjuvant chemotherapy, and 2) levels differ between black women and those of other racial groups.\n\nThe hypothesis is that bisphenol and phthalate levels will be similar to those of the general US female population at the time of diagnosis, however levels will increase during treatment due to exposure to plastics in the medical setting. The investigators also hypothesize that because of differences in personal care product use, black women may have higher urinary levels of bisphenols and phthalates prior to starting chemotherapy.', 'detailedDescription': 'Triple-negative breast cancer (TNBC) is an aggressive breast cancer subtype that does not express estrogen, progesterone, or the human epidermal growth factor (HER2/neu) receptors, and has a low overall survival rate compared to other types of breast cancer.\n\nUnlike hormone and HER2/neu positive breast cancers, targeted therapies are not available for TNBC. Thus, the systemic chemotherapeutic agent doxorubicin is widely used for the treatment of TNBC. However, doxorubicin resistance is common, and leads to poorer treatment outcomes.\n\nUnderstanding factors that contribute to doxorubicin resistance is critical to improving cancer treatment outcomes among women with TNBC. Pre-clinical in vitro studies indicate that exposure to endocrine disrupting chemicals, such as bisphenols and phthalates, contribute to doxorubicin resistance, but these findings have not been evaluated in humans.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women being treated at the George Washington University for stage I - III triple negative breast cancer who are scheduled to receive a neoadjuvant chemotherapy regimen containing doxorubicin.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of stage I - III triple negative breast cancer\n* scheduled to receive a neoadjuvant chemotherapy regimen including doxorubicin\n* receiving treatment at the George Washington University Cancer Center\n\nExclusion Criteria:\n\n* diagnosis of other types of breast cancer\n* not scheduled to receive doxorubicin as part of the neoadjuvant chemotherapy regimen\n* not planning to receive neoadjuvant chemotherapy at the George Washington University Cancer Center'}, 'identificationModule': {'nctId': 'NCT04268693', 'acronym': 'EDC-TNBC', 'briefTitle': 'Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'George Washington University'}, 'officialTitle': 'Bisphenol and Phthalate Exposures in Women With Triple Negative Breast Cancer Receiving Doxorubicin Chemotherapy - a Pilot Study', 'orgStudyIdInfo': {'id': 'NCR191600'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study cohort', 'description': 'urinary bisphenol and phthalate levels', 'interventionNames': ['Other: urine collection']}], 'interventions': [{'name': 'urine collection', 'type': 'OTHER', 'description': 'Collect three urine samples either in the clinic or at home. This will occur prior to starting neoadjuvant chemotherapy, and again at the end of the scheduled course of neoadjuvant chemotherapy.', 'armGroupLabels': ['Study cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20052', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Milken Institute School of Public Health, George Washington University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Kim Robien, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Milken Institute School of Public Health, George Washington University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Will not share data until study is complete and all data deidentified'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Washington University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kimberly Robien', 'investigatorAffiliation': 'George Washington University'}}}}