RecruitingNCT04564781

Predicting BCG Response

A Novel Multiplex Immunoassay for Predicting Intravesical BCG Response in Patients With Intermediate or High-risk Non-muscle Invasive Bladder Cancer

Sponsor

Cedars-Sinai Medical Center

Enrollment

400 participants

Start Date

Sep 18, 2020

Study Type

OBSERVATIONAL

Conditions

Bladder Cancer

Summary

To date, there are no diagnostics capable of predicting treatment response to intravesical BCG. Because of this severe limitation, nearly 50% of patients treated with BCG fail therapy and will a) require additional intravesical therapy or b) require cystectomy. A urine-based diagnostic that possesses the potential to accurately identify patients who will respond favorably to intravesical BCG is desperately needed.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study aims to predict which bladder cancer patients will respond well to BCG treatment — a common therapy that uses a weakened bacteria to stimulate the immune system inside the bladder to fight cancer — by analyzing tumor and blood samples before treatment begins. **You may be eligible if...** - You are 18 or older with non-muscle-invasive bladder cancer confirmed by biopsy (Ta, carcinoma in situ, or T1 stage) - All visible tumors have been removed within 30 days before BCG starts - Your cancer is intermediate or high grade - You have no signs of cancer spread to lymph nodes (for T1 stage) - BCG treatment is planned within 90 days of your diagnosis **You may NOT be eligible if...** - Your cancer is pure squamous cell carcinoma or adenocarcinoma - Your tumor has micropapillary features - You have cancer in your upper urinary tract (kidneys or ureters) - You have had another cancer in the past 5 years (some exceptions apply) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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