Clinical trial NCT05167916: Can Four Weeks-check Cystoscopy and Urine Cytology After Primary Complete Resection of T1 Bladder Cancer Replace Repeat Biopsy?
Official title: Can Four Weeks-check Cystoscopy and Urine Cytology After Primary Complete Resection of T1 Bladder Cancer Replace Repeat Biopsy?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Cancer
Keywords: Bladder cancer
Cystoscopy
Cytology
Repeat biopsy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of positive repeat biopsy for malignancy
timeFrame: 4 weeks
Secondary outcomes:
measure: Tumor recurrence rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura Urology and Nephrology Center
state: DK
Study officials:
affiliation: Mansoura University
name: Amr A Elsawy
role: PRINCIPAL_INVESTIGATOR
References: