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Pilot Study: Genetic Susceptibility to Tumor Recurrence and Progression in Patients With Non-Muscle Invasive Bladder Cancer

21 Years
Open (Enrolling)
Bladder Cancer, Urinary Cancer, Nonmuscle Invasive Bladder Cancer

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Trial Information

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.

Inclusion Criteria:

- They have been diagnosed with a primary nonmuscle invasive bladder cancer within the
previous 12 months.

- They speak English or a language for which we have a translated consent form

- They understand and agree to sign informed consent

- They agree to donate a 30ml blood sample

- They agree to give us a bladder tissue sample as part of normal clinical procedures
(three 3mm cold cup bladder biopsies or urothelial cells by bladder lavage)

- They agree to complete the study questionnaires

- They agree to have their pathology information reviewed. This could include biopsy

- All subjects must be age 21 or older

Exclusion Criteria:

- Age less than 21 years

- History of other cancer diagnosis excluding nonmelanoma skin cancers

- History of muscle invasive bladder cancer

- Initial diagnosis more than 12 months from entry date into study

- History of prior intravenous chemotherapy or radiation therapy

- Bladder histology other than transitional cell cancer and its variants.

- Pregnancy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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.

Outcome Time Frame:

conclusion of study

Safety Issue:


Principal Investigator

Sherri Donat, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

March 2004

Completion Date:

June 2013

Related Keywords:

  • Bladder Cancer
  • Urinary Cancer
  • Nonmuscle Invasive Bladder Cancer
  • Urinary Bladder Neoplasms
  • Disease Susceptibility
  • Recurrence



Memorial Sloan-Kettering Cancer Center New York, New York  10021