Can We Predict of the Response of High Risk Non Muscle Invasive Bladder Cancer Patients to Intravesical Bacillus Calmette-Guerin? The Role of Immunological Markers

Not Applicable

Completed

• Conditions: Bladder Cancer
• Interventions: Diagnostic Test: Urine ELISA for immunological markers (IL-2 and IL-10); Diagnostic Test: Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis

• Registration Number: NCT04723121
• Lead Sponsor: Mansoura University

Brief Summary

Intravesical BCG is the mainstay adjuvant management of high risk NMIBC. Adequacy of immune system stimulation is the determinant factor for patient response to BCG. Immunological markers for BCG-response could be helpful for urologists especially in the era of BCG shortage.

Objectives: To assess the predictive performance of different immunological markers on BCG-response in high risk NMIBC BCG-naïve patients.

Detailed Description

Background: Intravesical BCG is the mainstay adjuvant management of high risk NMIBC. Adequacy of immune system stimulation is the determinant factor for patient response to BCG. Immunological markers for BCG-response could be helpful for urologists especially in the era of BCG shortage.

Objectives: To assess the predictive performance of different immunological markers on BCG-response in high risk NMIBC BCG-naïve patients.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-03-01
• Primary Completion: 2019-05-01
• Study Completion: 2020-12-01
• Status Verified: 2021-01
• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-01-22
• Last Update Submitted: 2021-01-22
• Study First Posted: 2021-01-25
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

• patients with primary or recurrent NMIBC for whom primary TURBT was done.

Read More

Exclusion Criteria

1. Patients with previous BCG instillation,
2. benign pathology
3. Variant histology
4. Non urothelial carcinoma,
5. concommitent upper tract urothelial tumors, detrusor muscle invasion
6. low or intermediate risk NMIBC

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High risk NMIBC	Urine ELISA for immunological markers (IL-2 and IL-10)	Patients with primary or recurrent NMIBC for whom primary TURBT was done and intravesical BCG was administered
High risk NMIBC	Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis	Patients with primary or recurrent NMIBC for whom primary TURBT was done and intravesical BCG was administered

Primary Outcome Measures

Name	Time	Method
Progression	1 year	persistent/recurrent tumor during or after treatment with increasing tumor grade or upstaging to muscle invasion after initial complete response
Initial BCG complete response	3 months	free cystoscopy/negative cytology at 3 months.
Recurrence	1 year	Recurrence is defined as development of new tumor/positive cytology in patients with ICR

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, DK, Egypt