Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-01-17 @ 2:07 PM
Study NCT ID:
NCT03148158
Status:
UNKNOWN
Last Update Posted:
2018-01-09
First Post:
2017-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment Of Bladder Tumors Stage And Grade By Outpatient Flexible Cystoscopy Performed By Urology Resident
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D000093284', 'term': 'Non-Muscle Invasive Bladder Neoplasms'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D004194', 'term': 'Disease'}], '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': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003558', 'term': 'Cystoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003950', 'term': 'Diagnostic Techniques, Urological'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Bladder biopsy and urine cytology'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2019-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-06', 'studyFirstSubmitDate': '2017-05-08', 'studyFirstSubmitQcDate': '2017-05-09', 'lastUpdatePostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of clinical grade and stage of bladder lesions diagnosed by flexible cystoscopy done by urology residents', 'timeFrame': '1 year', 'description': 'Outcome measures by histopathological results of bladder biopsy'}], 'secondaryOutcomes': [{'measure': 'Evaluation of pain perception in patient undergoing flexible or rigid diagnostic cystoscopy', 'timeFrame': '1 year', 'description': 'Outcome measures by visual analog scale (VAS) pain score'}, {'measure': 'Assessment of the patient reported outcomes after both flexible and rigid cystoscopy', 'timeFrame': '1 year', 'description': 'Outcome measures by Freiburg Index of Patient Satisfaction (FIPS) questionnaire'}, {'measure': 'Assessment of the prognostic value of gross morphology with recurrence, progression', 'timeFrame': '2 year', 'description': 'Outcome measures by Number of patients surviving for two year without tumor recurrence will be counted and compared'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bladder Cancer', 'Flexible cystoscopy', 'Diagnosis'], 'conditions': ['Bladder Cancer', 'Flexible Cystoscopy', 'Non-muscle Invasive Bladder Cancer (NMIBC)', 'Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'This will be a prospective trial comparing the perspective gross morphological of bladder tumor assessment done by outpatient flexible cystoscopy performed by resident, inpatient rigid cystoscopy done by senior staff and their prediction of the degree of invasion of bladder tumor plus the prediction of the grade compared with the standard pathological result.\n\nAlso, assessment of the patient reported outcomes after both flexible and rigid cystoscopy will be done.\n\nIn the long run of the study, the prognostic gross morphology with recurrence, progression and cancer specific survival will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients diagnosed with suspected denovo, recurrent bladder mass or hematuria needing assessment by flexible cystoscopy will be asked to participate in this study at Urology and Nephrology Center Outpatient Clinics and will be provided with an informed consent form in line with Good Clinical Practise and the Declaration of Helsinki.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women 18 years or older\n* Denovo or recurrent NMIBC\n* Bladder mass discovered in hematuria investigation\n* Willing to share in study\n\nExclusion Criteria:\n\n* inability to cooperate with flexible cystoscopic evaluations\n* cystoscopies for other kind of intervention (e.g., removal of a ureteral stent)\n* Untreated infections\n* Other causes of storage or voiding symptoms as untreated benign prostatic hyperplasia (BPH) or interstitial cystitis\n* Unpassable urethral stricture'}, 'identificationModule': {'nctId': 'NCT03148158', 'briefTitle': 'Assessment Of Bladder Tumors Stage And Grade By Outpatient Flexible Cystoscopy Performed By Urology Resident', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Assessment Of Bladder Tumors Stage And Grade By Outpatient Flexible Cystoscopy Performed By Urology Resident', 'orgStudyIdInfo': {'id': 'F-Cystoscopy NMIBC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cystoscopy', 'type': 'DEVICE', 'description': 'Outpatient flexible cystoscopy and inpatient rigid cystoscopy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Aldakahlia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Abdelwahab R. Hashem, Msc', 'role': 'CONTACT', 'email': 'abdelwahab_hashem@yahoo.com', 'phone': '00201069678979'}, {'name': 'Mohammed H. Zahran, MD', 'role': 'CONTACT', 'email': 'zahranmha@yahoo.com', 'phone': '00201063338690'}], 'facility': 'Urology and Nephrology Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Abdelwahab R. Hashem, Msc', 'role': 'CONTACT', 'email': 'abdelwahab_hashem@yahoo.com', 'phone': '01069678979', 'phoneExt': '002'}, {'name': 'Mohammed H. Zahran, MD', 'role': 'CONTACT', 'email': 'zahranmha@yahoo.com', 'phone': '01063338690', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'Hassan Abol-Enein, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Urology and Nephrology center'}, {'name': 'Ahmed Mosbah, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Urology and Nephrology center'}, {'name': 'Mohamed Abdelbaset, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology and Nephrology Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator', 'investigatorFullName': 'Abdelwahab Hashem', 'investigatorAffiliation': 'Mansoura University'}}}}