Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT03591367
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
2018-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Potential Role Of MicroRNA-155 And Telomerase Reverse Transcriptase In Diagnosis Of Non-Muscle Invasive Bladder Cancer And Their Pathological Correlation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-01', 'studyFirstSubmitDate': '2018-07-08', 'studyFirstSubmitQcDate': '2018-07-08', 'lastUpdatePostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensitivity, specificity and positive and negative predictive values of combined MicroRNA-155 And Telomerase Reverse Transcriptase In diagnosis Of Non-Muscle Invasive Bladder Cancer', 'timeFrame': '1 year', 'description': 'compared by standard final pathological specimen'}], 'secondaryOutcomes': [{'measure': 'correlation between serum Vit D and Non-Muscle Invasive Bladder Cancer', 'timeFrame': '1 year', 'description': 'measured serum Vit D in ng/mL.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Cancer', 'Bladder Disease', 'Bladder Neoplasm', 'Micro-RNA']}, 'descriptionModule': {'briefSummary': 'We try to assess the potential role of telomerase reverse transcriptase and MicroRNA (miR-155) in diagnosis of non-muscle-invasive bladder cancer and their correlation with stage and grade of the tumor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women 18 years or older.\n* Patient with hematuria suspected to be of bladder origin clinically.\n* Willing to be participate in the study.\n\nExclusion Criteria:\n\n* Patient having another malignancy.\n* Hematuria of other causes as trauma and stones'}, 'identificationModule': {'nctId': 'NCT03591367', 'briefTitle': 'The Potential Role Of MicroRNA-155 And Telomerase Reverse Transcriptase In Diagnosis Of Non-Muscle Invasive Bladder Cancer And Their Pathological Correlation', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'The Potential Role Of MicroRNA-155 And Telomerase Reverse Transcriptase In Diagnosis Of Non-Muscle Invasive Bladder Cancer And Their Pathological Correlation', 'orgStudyIdInfo': {'id': 'MicroRNA-155 Bladder Cancer'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Hematuria due to suspicious superficial bladder tumor', 'description': 'MicroRNAs-155 (miRNAs-155) and Human telomerase reverse transcriptase (hTERT)', 'interventionNames': ['Diagnostic Test: MicroRNAs-155', 'Diagnostic Test: Human telomerase reverse transcriptase']}], 'interventions': [{'name': 'MicroRNAs-155', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['(miRNAs-155)'], 'description': 'Quantitative analysis of cell-free miR-155 using RT-qPCR.', 'armGroupLabels': ['Hematuria due to suspicious superficial bladder tumor']}, {'name': 'Human telomerase reverse transcriptase', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['(hTERT)'], 'description': 'Analysis TERT by TERT messenger RNA (mRNA)expression by reverse transcription-quantitative polymerase chain reaction.', 'armGroupLabels': ['Hematuria due to suspicious superficial bladder tumor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Aldakahlia', 'country': 'Egypt', 'facility': 'Urology and Nephrology Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Ahmed Mosbah, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Urology and nephrology center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}