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

Completed

• Conditions: Bladder Cancer
• Interventions: Procedure: Tissue Biopsy; Procedure: Magnetic Resonance Imaging (MRI)

• Registration Number: NCT02203136
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2014-06-25
• Study First Submitted: 2014-07-25
• Study First Submitted QC: 2014-07-28
• Study First Posted: 2014-07-29
• Status Verified: 2019-05
• Primary Completion: 2019-05-16
• Study Completion: 2019-05-16
• Last Update Submitted: 2019-05-20
• Last Update Posted: 2019-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Patients with biopsy proven bladder cancer of any age will be eligible for enrollment.

Exclusion Criteria

1. Contraindication to pelvic MRI (metallic implants/hardware, claustrophobia)
2. Participants who have previously received chemotherapy as part of multimodal therapy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Muscle Invasive Bladder Cancer (MIBC)	Magnetic Resonance Imaging (MRI)	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.
Muscle Invasive Bladder Cancer (MIBC)	Tissue Biopsy	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.

Primary Outcome Measures

Name	Time	Method
Detection Improvement of Cancer Outside of the Bladder	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.

Trial Locations

Locations (1)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States