Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-01-01 @ 2:00 AM
Study NCT ID:
NCT07052734
Status:
COMPLETED
Last Update Posted:
2025-07-06
First Post:
2025-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Miti-gene Recurrence Score in HR+/HER2- Chinese Breast Cancer Patients
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2843}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-28', 'studyFirstSubmitDate': '2025-06-28', 'studyFirstSubmitQcDate': '2025-06-28', 'lastUpdatePostDateStruct': {'date': '2025-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '10 years', 'description': 'Disease-Free Survival (DFS) is defined as the duration from the completion of curative surgery until the first occurrence of any of the following events: local or distant relapse of the breast cancer, development of a new primary cancer, or death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '10 years', 'description': 'Overall survival is defined as the duration from the completion of curative surgery until death from any cause.'}, {'measure': 'Distant relapse-free survival', 'timeFrame': '10 years', 'description': 'Distant relapse-free survival is defined as the duration from the completion of curative surgery until distant relapse of the breast cancer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Update and validate the performance of the 21-gene score in prognostic stratification for early-stage HR-positive, HER2-negative breast cancer in China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HR-positive, HER2-negative breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed age: 18-75 years.\n2. Early-stage invasive breast cancer, pN0-1.\n3. Molecular subtype: HR-positive (ER and/or PR positive), HER2-negative.\n4. At least five years of follow-up records (including cases with disease progression within five years and documented records).\n5. Sufficient FFPE samples for sectioning or frozen samples for RNA extraction and subsequent testing.\n\nExclusion Criteria:\n\n1. FFPE samples with tumor content \\<20%, and inability to enrich tumor regions through cutting.\n2. Insufficient extracted nucleic acid quantity or severe degradation preventing further experiments.\n3. Failure in RT-PCR amplification of housekeeping genes.\n4. Multiple primary breast cancers or a history of ipsilateral or contralateral breast cancer.\n5. Disease progression unrelated to breast cancer.\n6. Lack of prior signed consent for retrospective scientific research or exemption from informed consent.'}, 'identificationModule': {'nctId': 'NCT07052734', 'acronym': 'BC-MRS-01', 'briefTitle': 'Miti-gene Recurrence Score in HR+/HER2- Chinese Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Multicenter Retrospective Analysis of the Miti-gene Recurrence Score in Early-Stage Invasive HR-Positive, HER2-Negative Breast Cancer in China', 'orgStudyIdInfo': {'id': 'BC-MRS-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'wang shusen', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}