Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-01 @ 2:09 PM
Study NCT ID:
NCT04295967
Status:
UNKNOWN
Last Update Posted:
2020-03-05
First Post:
2020-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vasculogenic Mimicry in Urothelial Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-04', 'studyFirstSubmitDate': '2020-03-03', 'studyFirstSubmitQcDate': '2020-03-04', 'lastUpdatePostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the presence of vasculogenic mimicry in urothelial carcinomas by CD31-PAS double staining', 'timeFrame': 'baseline'}], 'secondaryOutcomes': [{'measure': 'Correlate the presence of vasculogenic mimicry with the clinicopathologic features in urothelial carcinoma.', 'timeFrame': 'baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urothelial Carcinoma']}, 'referencesModule': {'references': [{'pmid': '27776348', 'type': 'BACKGROUND', 'citation': 'Zhou L, Chang Y, Xu L, Hoang ST, Liu Z, Fu Q, Lin Z, Xu J. Prognostic value of vascular mimicry in patients with urothelial carcinoma of the bladder after radical cystectomy. Oncotarget. 2016 Nov 15;7(46):76214-76223. doi: 10.18632/oncotarget.12775.'}, {'pmid': '3418215', 'type': 'BACKGROUND', 'citation': 'Aso Y, Ushiyama T, Suzuki K, Tajima A, Naide Y, Ohshima S, Matsuura O, Fukushima M, Ota K, Ono Y, et al. [Use of VM-26 as a single agent in the treatment of transitional cell carcinoma of the urinary tract]. Nihon Gan Chiryo Gakkai Shi. 1988 May 20;23(5):1046-51. No abstract available. Japanese.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the investigators aim at:\n\n1. Evaluate the presence of vasculogenic mimicry in urothelial carcinomas by CD31-PAS double staining.\n2. Correlate the presence of vasculogenic mimicry with the clinicopathologic features as age, sex, TNM stage, pathological grade, recurrence, carcinoma in situ, lymphovascular emboli, lymph node metastasis, necrosis, surgical margin, multifocality and tumor size in urothelial carcinoma.', 'detailedDescription': 'Bladder cancer is the ninth most common cancer worldwide which seriously affects human health. In Egypt, it is the third common malignant tumor.\n\nUrothelial carcinoma (UC) is considered the most common histologic type of bladder cancer.\n\nIt is well recognized that the biological behavior of several cancers is closely related to their blood supply. Tumor progression and metastasis have been long associated with tumor angiogenesis. However, several studies demonstrated that vascular targeting drugs which induce endothelial cell apoptosis have a little effect. So, it has been suggested that novel tumor microcirculation patterns may exist in these neoplasms.\n\nVasculogenic mimicry (VM), is a novel tumor microcirculation system. Maniotis et al initially discovered VM in melanoma and defined these channels to be composed of tumor basement membrane lined externally by tumor cells, lacking blood vessel endothelium and containing plasma and red blood cells. So VM can be distinguished using immunohistochemical (IHC) staining and histochemical double staining. VM is CD31- or CD34-negative (endothelial markers) and periodic acid-Schiff (PAS) positive.\n\nVasculogenic mimicry was detected in several malignant tumors. Several studies reported that VM can promote tumor progression and metastasis and it is positively associated with pathological grade, stage, recurrence and drug resistance. Previous studies which evaluate, the role of VM in urothelial carcinoma yield controversial results. So, the value of VM in urothelial carcinomas and its relation to the clinicopathologic parameters remains to be elucidated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be conducted using formalin fixed paraffin embedded blocks of sixty cases of urothelial carcinomas . These blocks will be obtained from laboratory archives of the Pathology Department, Assiut University Hospital, Faculty of Medicine. Clinical data for this study will be obtained from laboratory archives of the pathology department, Assiut University Hospital, Assiut University.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Specimens of urothelial carcinoma.\n\nExclusion Criteria:\n\n* \\- Any criteria that not fulfill the inclusion criteria such as resected urinary bladder tumors other than urothelial carcinoma.'}, 'identificationModule': {'nctId': 'NCT04295967', 'briefTitle': 'Vasculogenic Mimicry in Urothelial Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Vasculogenic Mimicry in Urothelial Carcinoma and Its Association With Clinicopathologic Features', 'orgStudyIdInfo': {'id': 'VM in urothelial carcinoma'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'presence of recurrence of urothelial carcinoma', 'interventionNames': ['Other: formalin fixed paraffin embedded blocks']}, {'label': '2', 'description': 'absence of recurrence of urothelial carcinoma', 'interventionNames': ['Other: formalin fixed paraffin embedded blocks']}], 'interventions': [{'name': 'formalin fixed paraffin embedded blocks', 'type': 'OTHER', 'description': 'The study will be conducted using formalin fixed paraffin embedded blocks of seventy cases of urothelial carcinomas .CD31-PAS dual-staining will be performed to confirm the presence of VM.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ereny K Louis, demonstrator', 'role': 'CONTACT', 'email': 'ereny.kamal14@yahoo.com', 'phone': '+201023720295'}], 'overallOfficials': [{'name': 'Abeer R Mohamed, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'administrator', 'investigatorFullName': 'Ereny Kamal Louis', 'investigatorAffiliation': 'Assiut University'}}}}