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 University

Status: Completed

Conditions: Bladder Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04723121

AE20121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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204 participants in 1 patient group

High risk NMIBC

Other group

Description:

Patients with primary or recurrent NMIBC for whom primary TURBT was done and intravesical BCG was administered

Treatment:

Diagnostic Test: Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis

Diagnostic Test: Urine ELISA for immunological markers (IL-2 and IL-10)