Improving Clinical Staging for Muscle Invasive Bladder Cancer Through Molecular Profiling and Improved Imaging

Study Overview
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Brief Summary
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The goal of this research study is to improve detection of cancer outside of the bladder through genetic testing and improved imaging.

Detailed Description
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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.

Official Title
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Improving Clinical Staging for Muscle Invasive Bladder Cancer Through Molecular Profiling and Improved Imaging

Conditions
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Bladder Cancer

Intervention / Treatment
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* Procedure: Tissue Biopsy
* Procedure: Magnetic Resonance Imaging (MRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Patients with biopsy proven bladder cancer of any age will be eligible for enrollment. Exclusion Criteria: Contraindication to pelvic MRI (metallic implants/hardware, claustrophobia) Participants who have previously received chemotherapy as part of multimodal therapy.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Muscle Invasive Bladder Cancer (MIBC)<br>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<br>* During bladder cancer surgery, tissue specimen taken for molecular profiling.<br>Procedure: Magnetic Resonance Imaging (MRI)<br>* 3 Tesla pelvic magnetic resonance imaging (MRI) performed four weeks after bladder cancer surgery.<br>* Other names: MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection Improvement of Cancer Outside of the Bladder | 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. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Bladder cancer, Muscle invasive bladder cancer, MIBC, Biopsy specimen molecular profiling, Bladder surgery, Magnetic resonance imaging, Trans urethral resection of bladder