Improving Clinical Staging for Muscle Invasive Bladder Cancer Through Molecular Profiling and Improved Imaging
|ClinicalTrials.gov Identifier: NCT02203136|
Recruitment Status : Active, not recruiting
First Posted : July 29, 2014
Last Update Posted : August 2, 2018
|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|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 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
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|