Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-26 @ 12:57 AM
Study NCT ID:
NCT05586659
Status:
UNKNOWN
Last Update Posted:
2022-10-19
First Post:
2022-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiology of TNBC in Asyut Clinical Oncology Department
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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-15', 'studyFirstSubmitDate': '2022-10-15', 'studyFirstSubmitQcDate': '2022-10-15', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of TNBC', 'timeFrame': 'Baseline', 'description': 'Incidence of TNBC in clinical oncology department from 2015-2022'}, {'measure': 'Behavior of the disease and stage', 'timeFrame': 'baseline', 'description': 'Behavior of the disease and stage of presentation'}, {'measure': 'Types of treatment', 'timeFrame': 'baseline', 'description': 'Types of treatment'}], 'secondaryOutcomes': [{'measure': 'DFS', 'timeFrame': 'Baseline', 'description': 'Disease free survival'}, {'measure': 'PFS', 'timeFrame': 'Baseline', 'description': 'progression free survival'}, {'measure': 'OS', 'timeFrame': 'Baseline', 'description': 'overall survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '24101045', 'type': 'BACKGROUND', 'citation': 'Wolff AC, Hammond ME, Hicks DG, Dowsett M, McShane LM, Allison KH, Allred DC, Bartlett JM, Bilous M, Fitzgibbons P, Hanna W, Jenkins RB, Mangu PB, Paik S, Perez EA, Press MF, Spears PA, Vance GH, Viale G, Hayes DF; American Society of Clinical Oncology; College of American Pathologists. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013 Nov 1;31(31):3997-4013. doi: 10.1200/JCO.2013.50.9984. Epub 2013 Oct 7.'}, {'pmid': '18833576', 'type': 'BACKGROUND', 'citation': 'Lin NU, Claus E, Sohl J, Razzak AR, Arnaout A, Winer EP. Sites of distant recurrence and clinical outcomes in patients with metastatic triple-negative breast cancer: high incidence of central nervous system metastases. Cancer. 2008 Nov 15;113(10):2638-45. doi: 10.1002/cncr.23930.'}]}, 'descriptionModule': {'briefSummary': 'Epidemiological Study about behavior of TNBC in Clinical oncology department in 8 y in Asyut university hospital', 'detailedDescription': 'Breast Cancer )BC) is the most Common malignancy in women in 2020, there were 2.3 million women diagnosed with breast cancer and 685.000 deaths globally. Breast cancer rates are 88% higher in developed countries compared to developing countries .\n\nTNBC represents accounts for approximately 24% of all breast cancer in 2020 .While in Egypt it accounts for 11.05% according to Egyptian national BC (5). By gene expression profiling ,4 subtypes of TNBC emerged : luminal androgen receptor (LAR), mesenchymal stem-like (MSL), immunomodulatory (IM), basal-like (BL1 and BL2) . Most of cases are advanced with median survival about 14 months . Brain and visceral organs represent common sites of distant metastasis . So it is considered the worst prognosis . In addition , chemotherapy is only option in treatment with no available targeted options for decades. Now we have Immunotherapy (IO ) and PARP inhibitors in neoadjuvant (NAT) and metastatic setting For example : Key note 355 which add Pembrolizumab in NAT which lead to marked improvement in pathological complete response ( PCR ) And in high risk patient and have marked results in disease and event free survival(8) .Poly (ADP-ribase) poly merase -1 (PARP-1) inhibitors appear to particularly effective in BRCA 1/2 mutation carries (9) .As reviewed by rodleret al. emerging data suggest that BRCA 1/2 carriers with TNBC disease may respond favorably to cisplatin therapy .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'male or female with triple negative breast cancer Diagnosed as TNBC from ( 2015- 2022 ) confirmed by pathology\n\n\\- Adjuvant or metastatic', 'eligibilityCriteria': 'Inclusion Criteria:- Age ≥ 18\n\n* Male or female\n* Diagnosed as TNBC from ( 2015- 2022 ) confirmed by pathology\n* Adjuvant or metastatic\n\nExclusion Criteria:- Have other type of malignancy\n\n* HER2 , ER, PR positive'}, 'identificationModule': {'nctId': 'NCT05586659', 'briefTitle': 'Epidemiology of TNBC in Asyut Clinical Oncology Department', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Epidemiology of Triple Negative Breast Cancer in Asyut Clinical Oncology Department From 2015 to 2022 ( A Hospital Based Study)', 'orgStudyIdInfo': {'id': 'TNBC'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aya saber', 'role': 'CONTACT', 'email': 'ayasaber171186@gmail.com', 'phone': '01143980715'}, {'name': 'Samir Eid, professor', 'role': 'CONTACT', 'email': 'Samir@aun.edu.eg', 'phone': '01222302375'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Aya Saber Khalifa Mohammed', 'investigatorAffiliation': 'Assiut University'}}}}