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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829920
• Other study ID #: 08-0018.cc
• Status: Completed
• Phase: N/A
• First received: January 25, 2009
• Last updated: June 21, 2013
• Start date: November 2008
• Est. completion date: February 2013

Study information

• Verified date: June 2013
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of therapy	To determine the effect of therapy (cystectomy or chemotherapy) on circulating tumor cell (CTC) levels in bladder cancer patients.	baseline and then every 2 months	No
Secondary	Presence of baseline CTC	Assess for the presence of baseline CTC in bladder cancer patients with muscle-invasive or metastatic disease.	baseline and then every 2 months	No
Secondary	Assessing insulin like growth factor	Determine the feasibility of assessing insulin like growth factor (IGF) I-R and c-Met by FISH in circulating tumor cells of patients with advanced bladder cancer.	baseline and then every 2 months	No
Secondary	Correlation between CTC levels and clinical outcome	Evaluate for any potential correlation between CTC levels and clinical outcome	baseline and then every 2 months	No