Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-29 @ 8:33 PM
Study NCT ID:
NCT01649661
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2012-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D055991', 'term': 'Health Records, Personal'}, {'id': 'D017584', 'term': 'Reproductive History'}, {'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D000074602', 'term': 'Smoking Devices'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D008499', 'term': 'Medical Records'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D008487', 'term': 'Medical History Taking'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D015981', 'term': 'Epidemiologic Factors'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood sample collected at time of MRI for serum hormone analysis Postmenopausal women only'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 437}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-25', 'studyFirstSubmitDate': '2012-07-19', 'studyFirstSubmitQcDate': '2012-07-24', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'breast cancer risk factors and background parenchymal enhancement (BPE).', 'timeFrame': '1 year', 'description': 'A comparison of the distribution of breast cancer risk factors in women with low and high levels of BPE. The relationship between risk factors and categories of BPE (minimal/mild/moderate/marked) will be determined using ordinal logistic regression.'}], 'secondaryOutcomes': [{'measure': 'relationship between BPE and serum hormone levels at the time of MRI', 'timeFrame': '1 year', 'description': 'Determine the relationship between serum hormone levels (testosterone, estradiol (E2), estrone (E1), androstenedione (A4) and sex hormone binding globulin (SHBG)) at the time of MRI and degree of BPE in healthy high-risk postmenopausal women. The association between circulating serum hormone levels and BPE will be determined using linear regression.'}]}, 'conditionsModule': {'keywords': ['MRI', '12-125', 'premenopausal women', 'postmenopausal women', 'questionnaire'], 'conditions': ['Cancer Free Women']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to learn about how a woman's health history influences what a normal breast looks like on an MRI. The investigators also want to learn about how the amount of different natural hormones a woman has affects how the breast looks on an MRI. The investigator's hope is that this will help to find women at a high-risk of breast cancer."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The proposed study will involve cancer-free women who are undergoing breast MRI screening at MSKCC.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 21 years or older\n* be a cancer-free pre- or postmenopausal woman\n* have no prior personal history of any cancer (including DCIS, excluding nonmelanoma skin-cancer)\n* able to speak and read English because the questionnaire is only available in English\n* able to provide informed consent\n\nExclusion Criteria:\n\n* are pregnant at the time of MRI\n* have a prior personal history of any cancer (including DCIS, excluding nonmelanoma skin cancer)'}, 'identificationModule': {'nctId': 'NCT01649661', 'briefTitle': 'MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Epidemiology of MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk', 'orgStudyIdInfo': {'id': '12-125'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'premenopausal women', 'description': 'Only women already scheduled for a breast MRI will be included in the study, no additional MRIs will be scheduled for study purposes.', 'interventionNames': ['Behavioral: questionnaire']}, {'label': 'postmenopausal women', 'description': 'Only women already scheduled for a breast MRI will be included in the study, no additional MRIs will be scheduled for study purposes.', 'interventionNames': ['Behavioral: questionnaire']}], 'interventions': [{'name': 'questionnaire', 'type': 'BEHAVIORAL', 'otherNames': ['The study questionnaire is a 15-20 minute survey at or shortly after the time of MRI consisting of 27', 'questions in 7 domains:background information (e.g., date of birth, country of birth, race/ethnicity), medical', 'history, family history of cancer, reproductive history, use of hormonal medications, alcohol and', 'smoking, contact information/comments.'], 'armGroupLabels': ['postmenopausal women', 'premenopausal women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Janice Sung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'University of Southern California', 'class': 'OTHER'}, {'name': 'University of Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}