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

NCT00829920 | Completed DMC

• 1 other identifier: 08-0018.cc
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

Bladder cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Presence of baseline CTC

  baseline and then every 2 months

• Assessing insulin like growth factor

  baseline and then every 2 months

• Correlation between CTC levels and clinical outcome

  baseline and then every 2 months

Study Arms (1)

Bladder cancer

Patients with muscle invasive or metastatic bladder cancer who will be planning for treatment with surgery or chemotherapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Subjects who are unwilling or unable to comply with the study guidelines as determined by the principal investigator.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80010, United States

Location

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.

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Thomas W. Flaig, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2009
• First Posted: January 27, 2009
• Study Start: November 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: February 1, 2013
• Last Updated: June 25, 2013

Record last verified: 2013-06

Locations

US (1)