Markers of Response to Intravesical Bladder Cancer Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01007058|
Recruitment Status : Completed
First Posted : November 3, 2009
Last Update Posted : December 7, 2016
|Condition or disease|
In this study, researchers are looking at markers that they could use to identify - at an early time point - those patients who might not respond to this treatment. This would allow researchers to provide future patients with information about their chances of responding to such treatment. And, with this information, researchers could better counsel those patients who might benefit from a different therapy at an earlier time point.
Treatment with BCG or BCG plus interferon is currently the most effective nonsurgical treatment for superficial bladder cancer. However, at this time, there is no reliable test that can help researchers predict which patients will respond to this therapy. You will be receiving BCG or BCG plus interferon therapy as planned by your physician. This is a standard therapy that will be decided by your doctor and based on your disease characteristics. If you agree to take part in this study, your participation will not affect the treatment you will receive in any way. Your follow-up and disease monitoring will be done according to standard routines.
By participating in this study, you agree to provide researchers with 4 tablespoons (or as much as you can produce) of urine at the following time points.
- Before you start therapy.
- Just before and 4 hours after your last treatment (which usually occurs 6 weeks after start of treatment).
- Just before and 4 hours after your last treatment of the second course of therapy (which is usually about 3 months after the beginning of the first course of therapy.
In addition, you will provide researchers with a bladder wash sample. This sample will be collected during routine catheterization (for your planned treatment) or during your routine cystoscopic exam. Bladder wash samples will be collected at the following time points.
- Before you start therapy.
- Just before your last treatment (which usually occurs 6 weeks after start of treatment).
- At your first routine cystoscopic follow-up (which usually occurs at 3 months).
- At your second routine cystoscopic follow-up (which usually occurs at 6 months).
Your follow-up cystoscopies and maintenance therapy will be done according to routine care as decided by your doctor and are not affected by your participation in this study. You will be part of the study for about 24 months after beginning the treatments. At the end of that period, between 23 and 27 months, you will be checked with cystoscopy and cytology to see if the tumor has come back, as part of standard of care.
In addition, information will be collected from your medical chart about other medications that you are taking and other conditions, such as diabetes or heart disease, that you may have. Information will also be collected about previous treatment that you have had for bladder cancer as well as other treatments that you may receive during this study. This may include treatments that are received at an outside health facility. Neither your name nor your medical record number will be kept with this information. All of the information collected for this study will be kept in a locked cabinet to which only the researchers have access. Upon completion of the study, the information sheets will be destroyed.
This is an investigational study.
A total of 300 patients will take part in this study. All will be enrolled at MD Anderson.
|Study Type :||Observational|
|Actual Enrollment :||150 participants|
|Official Title:||Markers of Response to Intravesical Bladder Cancer Therapy|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Urine Collection and Bladder wash of Bladder Cancer Patients with Treatment of BCG or BCG plus interferon
- Number of Patients with Clinical tumor recurrence or progression by 24 months after initiation of intravesical immunotherapy [ Time Frame: Baseline to 24 months ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01007058
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Ashish M. Kamat, MD||M.D. Anderson Cancer Center|