MedTrace Logo

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

NCT05167916 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-12-22

No results posted yet for this study

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

Interventions

PROCEDURE

Outpatient check cytoscopy

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.

DIAGNOSTIC_TEST

Urine cytology

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.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Amr A Elsawy · Mansoura University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-12-01
Completion
2023-01-01

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05167916 on ClinicalTrials.gov