The Effect of Treatment on Circulating Tumor Cells in Bladder Cancer Patients With Muscle-invasive or Advanced Disease
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by University of Colorado, Denver.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Colorado, Denver
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00829920
First received: January 25, 2009
Last updated: January 22, 2012
Last verified: January 2009
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Purpose
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.
| 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:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2008 |
| Groups/Cohorts |
|---|
| muscle invasive or metastatic bladder 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
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 |
| Study First Received: | January 25, 2009 |
| Last Updated: | January 22, 2012 |
| Health Authority: | United States: Institutional Review Board |
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 May 21, 2013