Pilot Study: Genetic Susceptibility to Tumor Recurrence and Progression in Patients With Non-Muscle Invasive Bladder Cancer
This is a hospital based cohort study where subjects diagnosed within twelve months with
nonmuscle invasive bladder cancer will be evaluated to determine whether candidate genetic
variants are associated with the risk of recurrence and progression. Known tumor variables
will be stratified and correlated with markers. The long term goal is to estimate the
predicted risk of recurrence or progression well enough to modify surveillance schedules.
Since 40% of superficial bladder cancer patients will never recur or progress, these
individuals could return less frequently for followup, saving costs and discomfort. All
patients will receive usual care and be followed to determine rates of recurrence and
progression of the disease. Each subject will donate 30 ml of blood for extraction of
genomic DNA and isolation of lymphocytes to assess DNA damage/repair function. In addition,
each subject who undergoes a transurethral resection of the bladder (TURB) and/or random
bladder biopsies as part of his/her usual care will donate urothelial cells from the random
bladder biopsies for analyses of DNA damage/repair function. The DNA repair capacity of
lymphocytes will be correlated with that of normal bladder tissue to evaluate the use of
lymphocytes as a surrogate marker. When bladder biopsy tissue is not available, urothelial
cells will be obtained from a cystoscopic or catheterized bladder lavage.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Evaluate genetic variants (in the DNA repair genes, cell cycle genes, and detoxifying genes) and their association with recurrence and progression in early stage bladder cancer.
conclusion of study
Sherri Donat, MD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
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