Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-04-10 @ 5:44 AM
Study NCT ID:
NCT00555503
Status:
COMPLETED
Last Update Posted:
2016-12-02
First Post:
2007-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Mastectomy for Breast Cancer Risk Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}, {'id': 'D000275', 'term': 'Adjustment Disorders'}], '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'}, {'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Patient operative specimens, blood samples, and saliva samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 261}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-01', 'studyFirstSubmitDate': '2007-11-07', 'studyFirstSubmitQcDate': '2007-11-07', 'lastUpdatePostDateStruct': {'date': '2016-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary study endpoint is the quality of life of the individual patient at the end of one year. Quality of life is measured using standardized self-report instruments administered preoperatively and in annual follow-up.', 'timeFrame': '10 years'}], 'secondaryOutcomes': [{'measure': 'Cancer occurrence, adverse effects, imaging findings, and survival are all secondary outcomes that we will be following.', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prospective study', 'registry', 'quality of life', 'mastectomy', 'reconstructive surgical procedures', 'BrCa1', 'BrCa2', 'breast cancer prevention'], 'conditions': ['Quality of Life', 'Mastectomy', 'Breast Neoplasms', 'Genetic Predisposition to Disease', 'Adjustment Disorder']}, 'descriptionModule': {'briefSummary': 'This is a registry for patients who have a risk-reduction mastectomy ("prophylactic mastectomy") due to being at high risk for developing breast cancer, followed by breast reconstruction. Eligible patients include those who have a breast cancer-related gene, a strong family history of breast cancer, or a personal history of high-risk conditions such as cancer in the other breast or ductal carcinoma in situ (DCIS). Patients are enrolled in the registry before surgery, and are followed for up to ten years afterwards. In addition to studying medical outcomes, we will periodically survey patients for quality-of-life issues and psychological well-being. There is no compensation for being enrolled in this registry. This registry is conducted through the Department of Plastic Surgery at Georgetown University Hospital, and is a sub-registry to the Fisher Familial Cancer Registry at the Lombardi Comprehensive Cancer Center at Georgetown University.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients are enrolled from the plastic surgery, breast surgery, or oncology clinics at Georgetown University Hospital who are at elevated risk for breast cancer. Please note that the Registry can only enroll Georgetown University Hospital patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients at an elevated risk for breast cancer.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT00555503', 'briefTitle': 'Registry of Mastectomy for Breast Cancer Risk Reduction', 'organization': {'class': 'OTHER', 'fullName': 'Georgetown University'}, 'officialTitle': 'Registry of Mastectomy for Breast Cancer Risk Reduction', 'orgStudyIdInfo': {'id': '2007-383'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients who have risk-reduction mastectomy of any type, per protocol inclusion and exclusion criteria.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Scott L. Spear, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgetown University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgetown University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Plastic Surgery', 'investigatorFullName': 'Scott L. Spear, M.D.', 'investigatorAffiliation': 'Georgetown University'}}}}