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

This study has been completed.
Sponsor:
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
  Purpose

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.


Condition
Bladder Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Treatment on Circulating Tumor Cells in Bladder Cancer Patients With Muscle-invasive or Advanced Disease

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA

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


Enrollment: 44
Study Start Date: November 2008
Study Completion Date: February 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Bladder cancer
Patients with muscle invasive or metastatic bladder cancer who will be planning for treatment with surgery or chemotherapy.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829920

Locations
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80010
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Thomas W. Flaig, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00829920     History of Changes
Other Study ID Numbers: 08-0018.cc
Study First Received: January 25, 2009
Last Updated: June 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplastic Cells, Circulating
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on September 15, 2014