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  1. Advancing Regulatory Science

Precision Medicine Utilizing Bacillus Calmette–Guérin (BCG) Vaccine in Non-Muscle Invasive Bladder Cancer

CERSI Collaborators: M. Minhaj Siddiqui, MD (PI at the University of Maryland), David J. McConkey, PhD (Co-PI at Johns Hopkins University)

FDA Collaborators: Daniel Lee, MD, PhD, Chi Song, PhD, Emma Scott, PhD, Wenming Xiao, PhD, Peter F. Bross, MD

Project Start: October 19, 2022

Regulatory Science Challenge

Bladder cancer is a type of cancer that affects the bladder, which is the organ that holds urine. When people are diagnosed with bladder cancer, about 80% of patients have cancer that is superficial and non-muscle invasive. Doctors usually use a treatment called "BCG " as the first choice for this type of cancer. However, some people who get this treatment don't respond well to it, and their cancer might either recur or progress and spread to other parts of their body. BCG vaccines are currently in short supply; therefore, there is a need to determine which people will respond well to BCG treatment so that the vaccine can be used effectively.

Project Description and Goals

In this study, researchers will use blood samples from patients with non-muscle invasive bladder cancer who have been or will be treated with BCG. Some of these patients will be identified by searching past records in the specimen biobank, and some will be new patients from two universities (the University of Maryland and Johns Hopkins). Blood samples will be tested and analyzed using a technique called "whole exome sequencing", for clues about which genes might be important for predicting which patients with bladder cancer will have good anti-tumor response from BCG treatment. By doing this research, doctors can better predict which patients will benefit from the BCG treatment and help more people with bladder cancer when the BCG vaccine is in shortage.


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