Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
Study NCT ID:
NCT07275203
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-11-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Concordance of the Biology of Primary Breast Carcinoma and the Biology of Recurrence , Retrospective Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2025-11-27', 'studyFirstSubmitQcDate': '2025-11-27', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of receptor discordance between primary and recurrent breast cancer.', 'timeFrame': '2015-2025'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Concordance of Biology Between Primary Breast Carcinoma and the Recurrence']}, 'descriptionModule': {'briefSummary': 'the study will discuss the concordance of the biology of primary breast carcinoma and the biology of recurrence.\n\nThe study will be conducted at Department of Clinical Oncology, Sohag University Hospital and Sohag Cancer center, Sohag, Egypt.\n\nincluding Patients diagnosed and treated between 2015 and 2025 and Data will be collected from medical records, pathology reports, and radiology reports.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be conducted at Department of Clinical Oncology, Sohag University Hospital and Sohag Cancer center, Sohag, Egypt.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than18 years old at time of diagnosis of breast cancer.\n* Patients who had recurrent breast cancer following adjuvant treatment.\n* Biopsy was taken from the site of recurrence and biology was done.\n\nExclusion Criteria:\n\n* Patients with distant metastasis at time of presentation.\n* Patients diagnosed with double malignancy.\n* Patients with incomplete data records.\n* Recurrent breast cancer and biopsy difficult to be taken .'}, 'identificationModule': {'nctId': 'NCT07275203', 'briefTitle': 'Concordance of the Biology of Primary Breast Carcinoma and the Biology of Recurrence , Retrospective Study.', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Concordance of the Biology of Primary Breast Carcinoma and the Biology of Recurrence , Retrospective Study.', 'orgStudyIdInfo': {'id': 'Soh-Med--25-11-8MS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident physician at clinical oncology department', 'investigatorFullName': 'Mera Samy George Samy', 'investigatorAffiliation': 'Sohag University'}}}}