Can Four Weeks-check Cystoscopy and Urine Cytology After Primary Complete Resection of T1 Bladder Cancer Replace Repeat Biopsy?

NCT05167916 | Unknown

• 1 other identifier: AS-12-2021
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this prospective study is to evaluate the clinical performance of combined check cystoscopy and urine cytology findings 4 weeks after initial primary complete resection of T1 BC for detection of residual malignancy at repeat biopsy.

Conditions

Bladder Cancer

Keywords

Bladder cancer; Cystoscopy; Cytology; Repeat biopsy

Outcome Measures

Primary Outcomes (1)

• Rate of positive repeat biopsy for malignancy

  The primary outcome include evaluation of the clinical performance of combined urine cytology and outpatient check cystoscopy 4 weeks after primary complete resection of T1BC as a predictive tool for possible residual malignancy at repeat biopsy.

  4 weeks

Secondary Outcomes (1)

• Tumor recurrence rate

  1 year

Study Arms (1)

T1 Bladder cancer patients

EXPERIMENTAL

Procedure: Outpatient check cytoscopy; Diagnostic Test: Urine cytology

Interventions

Outpatient check cytoscopy PROCEDURE

Four weeks after primary TURBT, study participants will provide freshly voided urine sample which will be sent for cytology assessment by uropathologist in charge according to the Paris classification system. Suspicious sample for malignancy, low- and high-grade malignant samples will be considered positive results. On the other hand, hyperplastic or negative samples for malignancy will be defined as negative results. Thereafter, patients will be assessed by flexible white light check cystoscopy under local anesthesia using flexible instrument by single operator. Checklist will be fulfilled by the operator urologist. Check cystoscopy will be considered positive when encountering residual gross lesion at the area of previous resection or newly developed lesions or both.

T1 Bladder cancer patients

Urine cytology DIAGNOSTIC_TEST

Four weeks after primary TURBT, study participants will provide freshly voided urine sample which will be sent for cytology assessment by uropathologist in charge according to the Paris classification system. Suspicious sample for malignancy, low- and high-grade malignant samples will be considered positive results. On the other hand, hyperplastic or negative samples for malignancy will be defined as negative results. Thereafter, patients will be assessed by flexible white light check cystoscopy under local anesthesia using flexible instrument by single operator. Checklist will be fulfilled by the operator urologist. Check cystoscopy will be considered positive when encountering residual gross lesion at the area of previous resection or newly developed lesions or both.

T1 Bladder cancer patients

Eligibility Criteria

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

You may qualify if:

• Adult patients (aged \>18 years)
• Patients with primary or recurrent NMIBC for whom complete primary TURBT was done.

You may not qualify if:

• Patients with incomplete resection
• Patients with nonurothelial carcinoma or variant histology.
• Patient with biopsy proven muscle invasion, or Ta BC.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura Urology and Nephrology Center

Al Mansurah, DK, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

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

Study Officials

• Amr A Elsawy

  Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amr A Elsawy

CONTACT

01009428750; amrelsawy.unc@hotmail.com

Mahmoud Laymon

CONTACT

dr_mahmoudlaymon@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 22, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: December 22, 2021

Record last verified: 2021-12

Locations

EG (1)