Improving Clinical Staging for Muscle Invasive Bladder Cancer Through Molecular Profiling and Improved Imaging
|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: NCT02203136|
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : May 22, 2019
|Condition or disease||Intervention/treatment|
|Bladder Cancer||Procedure: Tissue Biopsy Procedure: Magnetic Resonance Imaging (MRI)|
If participant agrees to take part in the study, a piece of the tumor that is removed during the biopsy will be collected for research purposes. The tissue will be sent to the laboratory for genetic testing.
If they have had a computed tomography scan (CT scan) or magnetic resonance imaging scan (MRI) recently, information collected from the scan will be collected. If they have not had one recently, they will have an MRI with contrast as part of this study. They will receive a separate consent form for this MRI scan.
The results of the test will be given to their doctor, but the results will not be used to decide their treatment.
After they have surgery, information will be collected from their medical records, such as their diagnosis.
Length of Study:
- Their participation on this study will be over once their surgery is completed.
- This is an investigational study.
Up to 100 participants will take part in this study. All will be enrolled at MD Anderson.
|Study Type :||Observational|
|Actual Enrollment :||16 participants|
|Official Title:||Improving Clinical Staging for Muscle Invasive Bladder Cancer Through Molecular Profiling and Improved Imaging|
|Actual Study Start Date :||June 25, 2014|
|Actual Primary Completion Date :||May 16, 2019|
|Actual Study Completion Date :||May 16, 2019|
Muscle Invasive Bladder Cancer (MIBC)
During bladder cancer surgery, whole genome gene expression array assays obtained on tumor biopsy specimens. Analysis to determine biologic subtypes which will then be correlated with final pathology, identifying the subtype(s) associated with noc-MIBC. 3 Tesla pelvic magnetic resonance imaging (MRI) performed four weeks after bladder cancer surgery.
Procedure: Tissue Biopsy
During bladder cancer surgery, tissue specimen taken for molecular profiling.
Procedure: Magnetic Resonance Imaging (MRI)
3 Tesla pelvic magnetic resonance imaging (MRI) performed four weeks after bladder cancer surgery.
Other Name: MRI
- Detection Improvement of Cancer Outside of the Bladder [ Time Frame: 4 weeks ]Improved cross sectional imaging with pelvic MRI, and biopsy specimen molecular profiling used to identify muscle invasive bladder cancer (noc-MIBC). Analysis to determine biologic subtypes which will then be correlated with final pathology, identifying the subtype(s) associated with noc-MIBC.
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): NCT02203136
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Neema Navai, MD||M.D. Anderson Cancer Center|