Markers of Response to Intravesical Bladder Cancer Therapy
1 other identifier
observational
150
1 country
1
Brief Summary
The goal of this laboratory research study is to see if researchers can predict whose cancer will stay in remission and whose will return in patients receiving treatment for bladder cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 2, 2009
CompletedFirst Posted
Study publicly available on registry
November 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedDecember 7, 2016
December 1, 2016
10.8 years
November 2, 2009
December 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients with Clinical tumor recurrence or progression by 24 months after initiation of intravesical immunotherapy
Baseline to 24 months
Study Arms (1)
Response Markers
Urine Collection and Bladder wash of Bladder Cancer Patients with Treatment of BCG or BCG plus interferon
Eligibility Criteria
Bladder cancer patients, 18 years or older, who will be receiving treatment with BCG or BCG + Interferon at UT MD Anderson Cancer Center.
You may qualify if:
- Disease Characteristics:
- Histologically confirmed primary or recurrent non-muscle-invasive transitional cell carcinoma with an intact bladder
- Stage Ta, T1, or carcinoma in situ
- Grade 1, 2, or 3
- Primary disease site must be the urinary bladder
- No evidence of tumor invasion of the muscularis propria by cystoscopy and biopsy within the past 6 weeks
- Upper tract imaging within the prior 12 months
- Patient Characteristics:
- Age: 18 years and above
- Gender: Male or female
- Life expectancy: 24 months or greater
- Performance status: 0 - 1
- Prior Therapy:
- Biologic therapy: allowed
- Chemotherapy: allowed
- +9 more criteria
You may not qualify if:
- Ongoing Pregnancy
- Patients who are not eligible to receive standard-of-care intravesical immunotherapy such as
- histologically confirmed pure squamous cell carcinoma or pure adenocarcinoma,
- patients with nonurothelial bladder cancer such as sarcoma, and immunocompromised patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Kamat AM, Briggman J, Urbauer DL, Svatek R, Nogueras Gonzalez GM, Anderson R, Grossman HB, Prat F, Dinney CP. Cytokine Panel for Response to Intravesical Therapy (CyPRIT): Nomogram of Changes in Urinary Cytokine Levels Predicts Patient Response to Bacillus Calmette-Guerin. Eur Urol. 2016 Feb;69(2):197-200. doi: 10.1016/j.eururo.2015.06.023. Epub 2015 Jun 25.
PMID: 26119560DERIVED
Related Links
Biospecimen
4 tablespoons of urine and a bladder wash sample during catheterization (for planned treatment) or during routine cystoscopic exam, both samples at 4 different time points before, during and after therapy courses.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ashish M. Kamat, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2009
First Posted
November 3, 2009
Study Start
June 1, 2005
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
December 7, 2016
Record last verified: 2016-12