Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT04179318
Status:
UNKNOWN
Last Update Posted:
2019-11-27
First Post:
2019-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
the New Geneswell BCT in Vitro Diagnosis of Breast Cancer Prognosis
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': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-25', 'studyFirstSubmitDate': '2019-10-15', 'studyFirstSubmitQcDate': '2019-11-25', 'lastUpdatePostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparative assessment between risk groups', 'timeFrame': 'Month 9', 'description': 'By evaluating the 5-year disease-free survival rate (DFS) of patients in high and low risk groups, the statistical differences between the two groups were compared.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Geneswell BCT is a precise and qualitative in vitro diagnostic test. The expression of 9 genes was obtained from the formalin fixed paraffin embedded block (FFPE) of breast cancer tissue samples by RT-qPCR, and the patients were divided into high-risk group and low-risk group.\n\nThis test provides prognostic information to assess the risk of recurrence. The BCT score calculated by geneswell BCT was associated with the risk of recurrence. The higher the BCT score, the more likely it is to relapse, and vice versa.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women with hormone receptor positive (estrogen, ER + or progesterone PR +, HER2 negative, and pN0 or PN1) early breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients were diagnosed with invasive breast cancer with positive hormone receptor (including positive estrogen receptor or progesterone receptor) and negative human epidermal growth factor receptor 2 (HER2)\n* Axillary lymph node assessment : pN0 or PN1\n* Women aged 18 and over\n* Patients without chemotherapy after operation\n\nExclusion Criteria:\n\n* Patients with negative hormone receptor （both estrogen and progesterone receptor are negative）\n* Human epidermal growth factor receptor 2 （HER2） positive\n* Pathological nodule evaluation: pN2 or pN3\n* Male patients\n* Patients receiving chemotherapy after surgery'}, 'identificationModule': {'nctId': 'NCT04179318', 'briefTitle': 'the New Geneswell BCT in Vitro Diagnosis of Breast Cancer Prognosis', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'A Retrospective, International Multicenter, Single Arm Clinical Trial of the New Geneswell BCT in Vitro Diagnosis of Breast Cancer Prognosis', 'orgStudyIdInfo': {'id': 'YANWQ002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'low risk', 'description': 'BCT Score \\<4', 'interventionNames': ['Diagnostic Test: Geneswell BCT']}, {'label': 'high risk', 'description': 'BCT Score ≥4', 'interventionNames': ['Diagnostic Test: Geneswell BCT']}], 'interventions': [{'name': 'Geneswell BCT', 'type': 'DIAGNOSTIC_TEST', 'description': 'Geneswell BCT is a precise and qualitative in vitro diagnostic test. The expression of 9 genes was obtained from the formalin fixed paraffin embedded block (FFPE) of breast cancer tissue samples by RT-qPCR, and the patients were divided into high-risk group and low-risk group.', 'armGroupLabels': ['high risk', 'low risk']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Affiliated Hospital of Hangzhou Normal University', 'class': 'OTHER'}, {'name': 'Korea University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}