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The Effect of Treatment on Circulating Tumor Cells in Bladder Cancer Patients With Muscle-invasive or Advanced Disease

18 Years
Not Enrolling
Bladder Cancer

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Trial Information

The Effect of Treatment on Circulating Tumor Cells in Bladder Cancer Patients With Muscle-invasive or Advanced Disease

The measurement of circulating tumor cells is pursued in several cancers including breast
and prostate cancer. The number of cells measured in these cancers has been shown to be
prognostic. There is little information on the presence or importance of circulating tumor
cells in bladder cancer. This trial is designed to determine if patients with advanced
bladder cancer have circulating tumor cells and if these circulating cells are affected by
treatment of the cancer.

Inclusion Criteria:

- Pathological diagnosis of transitional cell carcinoma of the urothelium of at least
T2-4, Nx, Mx stage. Mixed histologies will be allowed (e.g. squamous
differentiation) as long as a transitional cell component is present.

- Clinical plans for surgery (with or without chemotherapy), radiation therapy, or

- Participants must not have any condition which in the investigator's opinion may
compromise the feasibility of completing the study.

- Subject must be 18 years of age or older

- Subject must be willing to have up to 4 peripheral blood samples obtained over a 6
month period of study.

- Prior therapies for bladder cancer will be allowed if patient currently has
muscle-invasive or metastatic bladder cancer despite the previous treatments.

- Predicted life expectancy of > 12 weeks.

Exclusion Criteria:

- Subjects who are unwilling or unable to comply with the study guidelines as
determined by the principal investigator.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Effect of therapy

Outcome Description:

To determine the effect of therapy (cystectomy or chemotherapy) on circulating tumor cell (CTC) levels in bladder cancer patients.

Outcome Time Frame:

baseline and then every 2 months

Safety Issue:


Principal Investigator

Thomas W. Flaig, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver


United States: Institutional Review Board

Study ID:



Start Date:

November 2008

Completion Date:

February 2013

Related Keywords:

  • Bladder Cancer
  • Bladder cancer
  • Urinary Bladder Neoplasms
  • Neoplastic Cells, Circulating



University of Colorado HospitalDenver, Colorado  80262