Status:
Completed
Clinicaltrials.gov identifier:
Sponsor:
Memorial Sloan Kettering Cancer Center
Participating centers:
New York, NY
Accrual:
116
Study Design:
Observational cohort study of patients with non-muscle invasive bladder cancer that includes genetic assessment of tumors and behavioral questionnaires to establish whether they can enhance the ability to predict tumor recurrence and progression over tumor grade and stage.
Rationale:
Tumor and grade are not adequate predictors of recurrence and progression in NMIBC and so by identifying behavioral risk factors from questionnaires and genetic susceptibility genes in DNA repair, cell cycle, and detoxifying pathways; perhaps, better prediction of NMIBC outcomes can occur.
Comments:
Samples will be obtained from blood, urine, and tumor tissue. The study hopes to predict the 40% of patients with NMIBC that may never recur or progress with tumor. The study has accrued 116 patients and analysis is pending. One concern is that often very little tumor tissue is present in NMIBC specimens and instrumented urine may not contain enough urothelial cancer cells for analysis.
