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

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Procedure: Outpatient check cytoscopy; Diagnostic test: Urine cytology

Detailed Description

Non muscle invasive bladder cancer (NMIBC) represents the vast majority (70%-80 %) of bladder cancer (BC) patients. T1 disease accounts for 15% to 30 % of NMIBC and is defined as invasion of the lamina propria without invasion of the muscularis propria.

Complete primary transurethral resection of bladder tumor (TURBT) is considered a crucial initial step not only to establish the diagnosis but also to achieve good prognosis and to guard against early recurrence due to missed lesions. Most current guidelines recommend repeat biopsy at 2 to 6 weeks after initial complete resection of T1 BC before initiation of adjuvant intravesical instillation of bacillus of Calmette and Guerin (BCG).

Repeat biopsy after presumable complete primary TURBT of T1 disease is quite helpful to confirm complete resection; in addition, it can provide additional pathological information as residual T1/Ta disease in 33%-55% of patients and T2 disease (upstaging) in 3%-10% of patients.

However, repeat biopsy is still an invasive procedure adding further cost and risk of anesthetic as well as surgical complications. In addition, it was shown in a recent published report by Adam and colleagues that repeat biopsy alters further patient management in a minority of patients and delay adjuvant intravesical BCG in 90% of patients.

Therefore, ensuring adequate primary complete resection by less invasive tools might be a helpful step to spare large proportion of T1 BC patients the added cost and morbidity of repeat biopsy, and to prioritize patients for intervention in systems with long waiting times, as well.

Urine cytology is a useful noninvasive method for detection of urothelial carcinoma of the urinary bladder. It has been established as a useful adjunct in both the diagnosis and follow-up especially for high grade tumor, and carcinoma in situ (CIS).

Urine cytology after complete primary resection of NMIBC had been investigated in previous reports as a determinant factor of possible overlooked tumors after primary resection.

On the other hand, check outpatient cystoscopy under local anesthesia remains the gold standard tool of initial diagnosis and surveillance of NMIBC. However, it lacks the sensitivity to detect flat lesions (more likely CIS).

In this context, the investigators assume that combined check outpatient cystoscopy and urine cytology 4 weeks after initial complete resection of T1 BC can provide reliable information about possibility of residual tumor/s that necessities repeat biopsy.

In the current study, the investigators aim at evaluating 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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 35516
      • Recruiting
      • Mansoura urology and nephrology center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: T1 Bladder cancer patients

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor recurrence rate	The secondary outcome includes the evaluation of predictive capacity of combined urine cytology and outpatient check cystoscopy for early tumor recurrence in the study participants.	1 year

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (ACTUAL): December 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 21, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Bladder cancer; Cystoscopy; Cytology; Repeat biopsy
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: AS-12-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No