Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-24 @ 10:20 PM
Study NCT ID:
NCT02593435
Status:
UNKNOWN
Last Update Posted:
2016-03-24
First Post:
2015-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Registration Program of BRCA1/2 Gene
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The samples, both tissue(s) and blood of patients should be provided for NGS test after ICF being signed'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8000}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-22', 'studyFirstSubmitDate': '2015-10-29', 'studyFirstSubmitQcDate': '2015-10-29', 'lastUpdatePostDateStruct': {'date': '2016-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Screening of large samples is to search the gene mutation of the breast cancer susceptibility gene (BRCA1 and BRCA2) in Chinese high risk group.', 'timeFrame': 'About 2 years'}], 'secondaryOutcomes': [{'measure': 'To build the database of the Chinese breast cancer BRCA1/2 mutation.', 'timeFrame': 'About 2 years'}, {'measure': 'To build the hazard model of Chinese breast cancer BRCA1/2 mutation.', 'timeFrame': 'About 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BRCA1/2 gene mutation', 'Breast Cancer', 'Chinese high risk group'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Purpose:\n\n1. Screening of large samples is to search the gene mutation of the breast cancer susceptibility gene (BRCA1 and BRCA2) in Chinese high risk group.\n2. To build the breast cancer BRCA1/2 mutation database of Chinese group.\n3. To build the hazard model of breast cancer BRCA1/2 mutation of Chinese group.', 'detailedDescription': 'It is the first large-scale and systematic study that fully recognize and review on the mutation spectrum of BRCA1/2 and the risk of Breast cancer in Chinese high risk group, it will be a Landmark research of susceptibility genes in Chinese breast cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese Breast Cancer Patients', 'healthyVolunteers': True, 'eligibilityCriteria': "Chinese Genetic/Familial breast cancer patients, and its first or second degree relatives with breast cancer (female or male).\n\nThe selection will be based on NCCN Clinical Practice Guidelines in Oncology (Genetic/Familial High-Risk Assessment: Breast and Ovarian).\n\nInclusion Criteria:\n\nPatients: it must be from independent family and meet the one or more of the following conditions.\n\n1. Patients' age at diagnosis: 45 years or younger.\n2. Patients' age at diagnosis: 50 years or younger.\n3. Breast cancer patients: it must meet the one or more of the following family medical histories.\n\n 3.1 Patients' age at diagnosis: 50 years or younger, and the one or more of the next of Kin has breast cancer.\n\n 3.2 Patients' age at diagnosis: any of age, and the one or more of the next of Kin has breast cancer that its age at diagnosis was 50 years or younger.\n\n 3.3 Patients' age at diagnosis: any of age, and the two or more of the next of Kin have breast cancer that its age at diagnosis was 50 years or younger.\n\n 3.4 Patients' age at diagnosis: any of age, and the one or more of the next of Kin has epithelial ovarian cancer.\n\n 3.5 Patients' age at diagnosis: any of age, and the two or more of the next of Kin have pancreatic cancer and/or prostate cancer (Gleason grading\\>7, any of age).\n\n 3.6 Patients' age at diagnosis: any of age, and the one or more of the close-male relatives has breast cancer.\n4. Triple negative patients' age of onset: 60 years or younger.\n5. Patients: male and have breast cancer.\n\nPatients' first or second degree relatives are BRCA1/2 mutation carrier (1-5 people):\n\nFirst or second degree female adult relatives of patients (age: 18 years or older), it will be selected from the same paternal or maternal side according to the family disease.\n\nFirst or second degree male relatives of patients have breast cancer.\n\nExclusion Criteria:\n\nN/A."}, 'identificationModule': {'nctId': 'NCT02593435', 'acronym': 'RCA', 'briefTitle': 'The Registration Program of BRCA1/2 Gene', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Anti-Cancer Association'}, 'officialTitle': 'The Registration Program of BRCA1/2 Gene in Chinese Breast Cancer Group', 'orgStudyIdInfo': {'id': 'CBRCA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No treatment', 'description': 'There will be two groups, one is breast cancer patient group, another group inlude the first-degree relatives and second degree relatives of patients with BRCA1/2 mutation. All volunteers should provid tissue(s) and blood for NGS test.', 'interventionNames': ['Genetic: NGS test']}], 'interventions': [{'name': 'NGS test', 'type': 'GENETIC', 'description': 'To record the characteristic QC parameters and evaluate the detection performance of Next-Generation Sequencing (NGS), including coverage depth and sequence similarity, then be used to evaluate the quality of base recognition and alignment.\n\nTo know mutation characteristic spectrum of BRCA1/2.', 'armGroupLabels': ['No treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100071', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tao Wang, Doctor', 'role': 'CONTACT', 'email': 'wangtao6@hotmail.com', 'phone': '+86-139-1092-8773'}, {'name': 'Shu-Juan Li', 'role': 'CONTACT', 'email': 'lsjhe12345@163.com', 'phone': '86-010-6694-7798'}, {'name': 'Ze-Fei Jiang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The 307th Hospital of Chinese People's Liberation Army", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Tao Wang, Doctor', 'role': 'CONTACT', 'email': 'wangtao6@hotmail.com', 'phone': '86-139-1092-8773'}, {'name': 'Zheng Jiang', 'role': 'CONTACT', 'email': 'keyan307@163.com', 'phone': '86-010-6694-7016'}], 'overallOfficials': [{'name': 'Ze-Fei Jiang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '307 Hospital of PLA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "The data-sharing of the volunteers' genetic information need be discussed more."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Anti-Cancer Association', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}