Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-24 @ 4:23 PM
Study NCT ID:
NCT03841266
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2019-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Recurrence Risk Evaluation by 21-gene Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-12', 'studyFirstSubmitDate': '2019-02-11', 'studyFirstSubmitQcDate': '2019-02-12', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation analysis', 'timeFrame': 'Janyary 1, 2019-December 31, 2019', 'description': 'x2 value and P value of chi-square test'}], 'secondaryOutcomes': [{'measure': 'consistency analysis', 'timeFrame': 'Janyary 1, 2019-December 31, 2019', 'description': 'kappa value, P value of consistency analysis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relationship and Consistency Analysis']}, 'descriptionModule': {'briefSummary': 'Breast cancer patients with early breast cancer were enrolled according to the inclusion criteria. Baseline characteristics were recorded from medical record system. Recurrence score were obtained by 21-gene detection kits from different biological companies. Relationship between recurrence score and the prognosis was explored. Meanwhile, the investigators analyzed the consistency of the results obtained from various 21-gene test kits and immunohistochemistry detection.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer patients with early breast cancer were enrolled according to the inclusion criteria. Baseline characteristics were recorded from medical record system. Recurrence score were obtained by 21-gene detection kits from different biological companies. Relationship between recurrence score and the prognosis was explored. Meanwhile, we analyzed the consistency of the results obtained from various 21-gene test kits and immunohistochemistry detection.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. breast cancer in stage I-III, tumor size\\>0.5cm\n2. lymph nodes negative\n3. hormone receptor positive （ER+/PR+,ER+/PR-,ER-/PR+）\n4. HER2 negative（IHC 0 or +， FISH negative）\n5. receive endocrine therapy only\n6. enough FFPE samples within 10 years（3\\~6 10μm ）\n7. patients with integrated medical records\n\nExclusion Criteria:\n\n1. Tumor cells \\<5%\n2. Isolated RNA\\<500ng'}, 'identificationModule': {'nctId': 'NCT03841266', 'briefTitle': 'Recurrence Risk Evaluation by 21-gene Detection', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Postoperative Recurrence Risk Evaluation of Hormone Receptor Positive, Her-2 Negative Breast Cancer by Using Different 21-gene Detection Kits (REBCK)', 'orgStudyIdInfo': {'id': 'KY2019'}}, 'armsInterventionsModule': {'interventions': [{'name': 'recurrence risk evaluation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Recurrence score were obtained by 21-gene detection kits from different biological companies. The expression of ER, PR, and Her-2 were also detected by IHC.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'country': 'China', 'facility': 'Xijing hoapital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Thyroid breast and vascular surgery, Principal Investigator', 'investigatorFullName': 'LiNanlin,Ph.D, Chief Physician,Clinical Professor', 'investigatorAffiliation': 'Xijing Hospital'}}}}