Assessment Of Bladder Tumors Stage And Grade By Outpatient Flexible Cystoscopy Performed By Urology Resident

NCT03148158 | Unknown DMC

• 1 other identifier: F-Cystoscopy NMIBC
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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. Also, assessment of the patient reported outcomes after both flexible and rigid cystoscopy will be done. In the long run of the study, the prognostic gross morphology with recurrence, progression and cancer specific survival will be assessed.

Conditions

Bladder Cancer; Flexible Cystoscopy; Non-muscle Invasive Bladder Cancer (NMIBC); Pain, Postoperative

Keywords

Bladder Cancer; Flexible cystoscopy; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Assessment of clinical grade and stage of bladder lesions diagnosed by flexible cystoscopy done by urology residents

  Outcome measures by histopathological results of bladder biopsy

  1 year

Secondary Outcomes (3)

• Evaluation of pain perception in patient undergoing flexible or rigid diagnostic cystoscopy

  1 year

• Assessment of the patient reported outcomes after both flexible and rigid cystoscopy

  1 year

• Assessment of the prognostic value of gross morphology with recurrence, progression

  2 year

Interventions

Cystoscopy DEVICE

Outpatient flexible cystoscopy and inpatient rigid cystoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Men and women 18 years or older
• Denovo or recurrent NMIBC
• Bladder mass discovered in hematuria investigation
• Willing to share in study

You may not qualify if:

• inability to cooperate with flexible cystoscopic evaluations
• cystoscopies for other kind of intervention (e.g., removal of a ureteral stent)
• Untreated infections
• Other causes of storage or voiding symptoms as untreated benign prostatic hyperplasia (BPH) or interstitial cystitis
• Unpassable urethral stricture

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bladder biopsy and urine cytology

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Pain, Postoperative; Disease

Interventions

Cystoscopy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Hassan Abol-Enein, MD

  Urology and Nephrology center

  STUDY CHAIR

• Ahmed Mosbah, MD

  Urology and Nephrology center

  STUDY DIRECTOR

• Mohamed Abdelbaset, Msc

  Urology and Nephrology Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdelwahab R. Hashem, Msc

CONTACT

01069678979; abdelwahab_hashem@yahoo.com

Mohammed H. Zahran, MD

CONTACT

01063338690; zahranmha@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: January 15, 2018
• Primary Completion: June 15, 2019
• Study Completion: June 15, 2019
• Last Updated: January 9, 2018

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)