Clinical trial NCT00829920: The Effect of Treatment on Circulating Tumor Cells in Bladder Cancer Patients With Muscle-invasive or Advanced Disease
Official title: The Effect of Treatment on Circulating Tumor Cells in Bladder Cancer Patients With Muscle-invasive or Advanced Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: Bladder cancer
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2009-01-27
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with muscle-invasive or metastatic bladder cancer with plans for cancer treatment.

Brief summary: The investigators hypothesize that circulating tumor cells (CTC) will be observed in patients with muscle-invasive or metastatic bladder cancer and that CTC will become undetectable, at least transiently, in a fraction of patients after treatment. To investigate this hypothesis, investigators will assess the levels of CTCs both before and after treatment. The feasibility and potential value of fluorescent in situ hybridization (FISH) in the CTCs will be assessed.

Detailed description: 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.

Eligibility criteria: 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 chemotherapy.
* 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.

Primary outcomes:
measure: Effect of therapy
timeFrame: baseline and then every 2 months
Secondary outcomes:
measure: Presence of baseline CTC
timeFrame: baseline and then every 2 months
measure: Assessing insulin like growth factor
timeFrame: baseline and then every 2 months
measure: Correlation between CTC levels and clinical outcome
timeFrame: baseline and then every 2 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Thomas W. Flaig, MD
role: PRINCIPAL_INVESTIGATOR
References: