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

Mansoura University204 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

204

Conditions

Bladder Cancer

Interventions

Urine ELISA for immunological markers (IL-2 and IL-10)DIAGNOSTIC_TEST

IL-2 and IL-10 levels were measured in the supernatants. Natural human-produced IL-2 and IL-10 concen¬trations were determined in the urine of all patients and controls by solid phase ELISA Quantikine IL-2 Immunoassay and IL-10 Immunoassay, respectively

Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysisDIAGNOSTIC_TEST

blood samples using QIAamp® RNA Blood Mini kit (QIAGEN, USA). 1 μg of total RNA was reverse transcribed with random primers, using High Capacity cDNA Archive Kit (Applied Biosystems, Foster City, CA, USA). RT-qPCR analysis was carried out with SYBER Green PCR Master Mix (Applied Biosystems, Foster City, CA, USA). Primers for TNF-α, CTLA4, T-bet+, GATA3+, FoxP3+ and GABDH as PCR control

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients with primary or recurrent NMIBC for whom primary TURBT was done. 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

Locations (1)

Urology and Nephrology Center

Al Mansurah, DK, Egypt

Outcomes

Primary Outcomes

Initial BCG complete response

free cystoscopy/negative cytology at 3 months.

Time frame: 3 months

Recurrence

Recurrence is defined as development of new tumor/positive cytology in patients with ICR

Time frame: 1 year

Progression

persistent/recurrent tumor during or after treatment with increasing tumor grade or upstaging to muscle invasion after initial complete response

Time frame: 1 year

Data from ClinicalTrials.gov

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