Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:42 AM
Study NCT ID:
NCT00255060
Status:
COMPLETED
Last Update Posted:
2010-07-20
First Post:
2005-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comprehensive Screening for Women at High Genetic Risk for Developing Breast Cancer
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-16', 'studyFirstSubmitDate': '2005-11-15', 'studyFirstSubmitQcDate': '2005-11-15', 'lastUpdatePostDateStruct': {'date': '2010-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To screen women who are high risk for breast cancer with breast MRI, mammogram and random periareolar fine needle aspiration.', 'detailedDescription': "General Purpose: The purpose of our protocol is develop a comprehensive screening protocol for women at high risk for developing breast cancer in the hopes of detecting breast cancer or it's precursor lesions at the earliest possible stage and reducing breast cancer mortality.\n\nThe following are our specific goals in this endeavor;\n\n1. To assess the sensitivity and specificity of MRI in breast cancer detection in women at high risk compared to mammography\n2. To assess the ability of random periareolar fine needle aspiration to detect abnormal ductal cells and to correlate these results with MRI and mammogram findings\n3. To assess appropriate screening intervals for BRCA1/2 mutation carriers and women with a \\>10% risk of developing breast cancer in ten years The following aims will be outlined in detail under methodology."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with high risk of breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Subjects must be female, between the ages of 25 and 65, or ten years younger than the youngest breast cancer diagnosed in the family, or have no mutation identified but have a greater than 10% risk of developing breast cancer in ten years (based on the Claus Model).\n\nMay have had previous breast or ovarian cancer, but must be at least one year out from treatment of a Stage 1 or early 2 cancer.'}, 'identificationModule': {'nctId': 'NCT00255060', 'briefTitle': 'Comprehensive Screening for Women at High Genetic Risk for Developing Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Comprehensive Screening for Women at High Genetic Risk for Developing Breast Cancer', 'orgStudyIdInfo': {'id': 'BRSNSTU0002'}, 'secondaryIdInfos': [{'id': '77716'}, {'id': 'BRSNSTU0002'}, {'id': 'NCT00255060'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'James M Ford', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'oldNameTitle': 'James M Ford', 'oldOrganization': 'Stanford University School of Medicine'}}}}