Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT06433804
Status:
COMPLETED
Last Update Posted:
2024-05-30
First Post:
2024-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinicopathological Parameters of HER2 Low Breast Cancers
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': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2024-05-16', 'studyFirstSubmitQcDate': '2024-05-29', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Age (in years)', 'timeFrame': 'JANUARY 2022- DECEMBER 2023', 'description': 'It will be measured for HER2 low breast cancer patients'}, {'measure': 'Tumor stage (categorised from T1-T4)', 'timeFrame': 'JANUARY 2022- DECEMBER 2023', 'description': 'This denotes status of stage of tumor- T1, T2, T3, T4. It will be measured for HER2 low breast cancer patients'}, {'measure': 'N stage (categorised from N0-N3)', 'timeFrame': 'JANUARY 2022- DECEMBER 2023', 'description': 'This denotes status of nodal involevement- N0, N1, N2 or N3. It will be measured for HER2 low breast cancer patients'}, {'measure': 'Tumor grade (categorised from G1-G3)', 'timeFrame': 'JANUARY 2022- DECEMBER 2023', 'description': 'This denotes whether tumor is well, modeartely or porrly differentiated. It will be measured for HER2 low breast cancer patients.'}, {'measure': 'Surrogate molecular classification (Categorised as luminal/ triple negative)', 'timeFrame': 'JANUARY 2022- DECEMBER 2023', 'description': 'This denoted the molecular classification of breast cancer based on ER, PR, Her2 expression.'}, {'measure': 'Androgen receptor expression (Denoted as present or absent)', 'timeFrame': 'JANUARY 2022- DECEMBER 2023', 'description': 'This denoted the immunohistochemical expression of androgen receptor which would be evaluted in all cases of HER2 low breast cancer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HER2 Low Breast Cancers']}, 'descriptionModule': {'briefSummary': 'This was a retrospective cohort study which included all histologically proven cases of breast cancer in the 2 years from January 2022- December 2023 at a tertiary care centre.\n\nThis study was performed in line with STROCSS criteria. The following clinicopathological data was retrieved from the histopathological records- age, tumor size, nodal involvement, lymphovascular/ perineural invasion, and Bloom Richardson grading.\n\nRoutine histopathological processing was done followed by immunohistochemical analysis for ER, PR, HER2, Ki67 and AR. All the cases were categorised into Luminal A, B, Her2 enriched and triple-negative breast cancer based on the surrogate molecular classification. Further, all the cases were categorised into HER2 negative (no staining or incomplete weak membrane staining in ≤10% tumor cells), HER2 3+ (complete membranous staining) and HER2 low (1-2+ staining without amplification on ISH) based on consensus of two pathology consultants. The present study aims to evaluate the clinicopathological parameters of the HER2 low breast cancers.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All histologically proven cases of breast cancer in the 2 years from January 2022- December 2023', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All histologically proven cases of breast cancer in the 2 years from January 2022- December 2023\n\nExclusion Criteria:\n\n* Benign breast tumors'}, 'identificationModule': {'nctId': 'NCT06433804', 'briefTitle': 'Clinicopathological Parameters of HER2 Low Breast Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Vardhman Mahavir Medical College And Safdarjung Hospital'}, 'officialTitle': 'Exploring the Clinicopathological Parameters of HER2 Low Breast Cancers', 'orgStudyIdInfo': {'id': 'CC-229'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HER2 low', 'interventionNames': ['Diagnostic Test: HER2 IHC']}, {'label': 'HER2 negative', 'interventionNames': ['Diagnostic Test: HER2 IHC']}], 'interventions': [{'name': 'HER2 IHC', 'type': 'DIAGNOSTIC_TEST', 'description': 'Immunohistochemistry for HER2', 'armGroupLabels': ['HER2 low', 'HER2 negative']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New Delhi', 'country': 'India', 'facility': 'VMMC SJH', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vardhman Mahavir Medical College And Safdarjung Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSISTANT PROFESSOR', 'investigatorFullName': 'SANA AHUJA', 'investigatorAffiliation': 'Vardhman Mahavir Medical College And Safdarjung Hospital'}}}}