Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT07056205
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-09
First Post:
2025-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Expression of ER,PR and HER2/Neu in Initial and Recurrent Breast Cancer.
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Archived histological slides and immune-stained slides of 100 patient with initial and recurrent mammary carcinoma will be obtained from Pathology Laboratory at Sohag Oncology Center.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-29', 'studyFirstSubmitDate': '2025-06-29', 'studyFirstSubmitQcDate': '2025-06-29', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison between initial and recurrent breast cancer in immunohistochemical expression of ER,PR and HER2/neu', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Correlate the results of immunohistochemical expression of ER,PRand HER2/neu with the patients age ,sex,nodal status and lymphovascular invasion', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ER,PR,HER2/neu,breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Expression of ER, PR and HER2/neu in initial and recurrent breast cancer and correlate the results to different clinical and pathological parameters as patient age,sex, tumor location, status of nodal involvement and lymphovascular invasion', 'detailedDescription': "Clinical data, pathological data, expression status of ER, PR and HER2/neu of both initial tumor and recurrent tumor and received treatment for BC patients diagnosed between January 2021 and December 2024 will be extracted from archive of multidisciplinary team (MDT) for management of BC at Sohag Oncology Center. In addition; hematoxylin and eosin stained slides and immune-stained slides for ER, PR and HER2/neu for selected patient's will be retrieved from archives of Pathology unit at Sohag Oncology Center and reviewed to confirm pathological features, ER expression, PR expression and HER2 status of both initial and recurrent tumor tissues."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'archived histological slides and immune-stained slides of100 patient with initial and recurrent mammary carcinoma will be obtained from Pathology Laboratory at Sohag Oncology Center.', 'genderDescription': '\\- Inclusion criteria: Patients with excised breast cancer then experienced recurrence at same site. Patients with evaluated ER, PR and HER2/neu for both initial and recurrent tumors.\n\n\\- Exclusion criteria: Cases with insufficient clinical of pathological data. Deficient ER, PR and HER2/neu status in either initial or recurrent tumor', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with excised breast cancer then experienced recurrence at same site. Patients with evaluated ER, PR and HER2/neu for both initial and recurrent tumors.\n\nExclusion Criteria:\n\n* Cases with insufficient clinical of pathological data. Deficient ER, PR and HER2/neu status in either initial or recurrent tumor'}, 'identificationModule': {'nctId': 'NCT07056205', 'briefTitle': 'Comparative Expression of ER,PR and HER2/Neu in Initial and Recurrent Breast Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Comparative Expression of ER,PR and HER2/Neu in Initial and Recurrent Breast Cancer.', 'orgStudyIdInfo': {'id': 'Soh-Med--25-5-1MS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'archived histological slides and immune-stained slides of 100 patient with breast cancer'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Faculty of medicine', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'No decided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Comparative expression of ER, PR and HER2/neu in initial and recurrent breast cancer.', 'investigatorFullName': 'Abdelmoaty Nafady Abdelmoaty', 'investigatorAffiliation': 'Sohag University'}}}}