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

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 16, 2019

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • M.D. Anderson Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Neema Navai, MD, Principal Investigator, M.D. Anderson Cancer Center

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