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

This study has been completed.
Sponsor:
Collaborator:
University of Colorado Hospital
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00829920
First received: January 25, 2009
Last updated: June 21, 2013
Last verified: June 2013

January 25, 2009
June 21, 2013
November 2008
November 2012   (final data collection date for primary outcome measure)
Effect of therapy [ Time Frame: baseline and then every 2 months ] [ Designated as safety issue: No ]
To determine the effect of therapy (cystectomy or chemotherapy) on circulating tumor cell (CTC) levels in bladder cancer patients.
To determine the effect of therapy (cystectomy or chemotherapy) on circulating tumor cell (CTC) levels in bladder cancer patients. [ Time Frame: baseline and then every 2 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00829920 on ClinicalTrials.gov Archive Site
  • Presence of baseline CTC [ Time Frame: baseline and then every 2 months ] [ Designated as safety issue: No ]
    Assess for the presence of baseline CTC in bladder cancer patients with muscle-invasive or metastatic disease.
  • Assessing insulin like growth factor [ Time Frame: baseline and then every 2 months ] [ Designated as safety issue: No ]
    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.
  • Correlation between CTC levels and clinical outcome [ Time Frame: baseline and then every 2 months ] [ Designated as safety issue: No ]
    Evaluate for any potential correlation between CTC levels and clinical outcome
  • Assess for the presence of baseline CTC in bladder cancer patients with muscle-invasive or metastatic disease. [ Time Frame: baseline and then every 2 months ] [ Designated as safety issue: No ]
  • Determine the feasibility of assessing IGF I-R and c-Met by FISH in circulating tumor cells of patients with advanced bladder cancer. [ Time Frame: baseline and then every 2 months ] [ Designated as safety issue: No ]
  • Evaluate for any potential correlation between CTC levels and clinical outcome [ Time Frame: baseline and then every 2 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Effect of Treatment on Circulating Tumor Cells in Bladder Cancer Patients With Muscle-invasive or Advanced Disease
The Effect of Treatment on Circulating Tumor Cells in Bladder Cancer Patients With Muscle-invasive or Advanced Disease

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum from patients undergoing treatment for muscle-invasive or metastatic bladder cancer who are planning for surgical bladder removal or chemotherapy will be acquired.

Non-Probability Sample

Patients with muscle-invasive or metastatic bladder cancer with plans for cancer treatment.

Bladder Cancer
Not Provided
Bladder cancer
Patients with muscle invasive or metastatic bladder cancer who will be planning for treatment with surgery or chemotherapy.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
February 2013
November 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00829920
08-0018.cc
Yes
University of Colorado, Denver
University of Colorado, Denver
University of Colorado Hospital
Principal Investigator: Thomas W. Flaig, MD University of Colorado, Denver
University of Colorado, Denver
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP