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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 204
- Locations
- 1
- Primary Endpoint
- Progression
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with primary or recurrent NMIBC for whom primary TURBT was done.
Exclusion Criteria
- •Patients with previous BCG instillation,
- •benign pathology
- •Variant histology
- •Non urothelial carcinoma,
- •concommitent upper tract urothelial tumors, detrusor muscle invasion
- •low or intermediate risk NMIBC
Arms & Interventions
High risk NMIBC
Patients with primary or recurrent NMIBC for whom primary TURBT was done and intravesical BCG was administered
Intervention: Urine ELISA for immunological markers (IL-2 and IL-10) (Diagnostic Test)
High risk NMIBC
Patients with primary or recurrent NMIBC for whom primary TURBT was done and intravesical BCG was administered
Intervention: Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis (Diagnostic Test)
Outcomes
Primary Outcomes
Progression
Time Frame: 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
Time Frame: 3 months
free cystoscopy/negative cytology at 3 months.
Recurrence
Time Frame: 1 year
Recurrence is defined as development of new tumor/positive cytology in patients with ICR
Secondary Outcomes
No secondary outcomes reported
Investigators
Amr Abdel-Lateif El-Sawy
Principal Investigator
Mansoura University