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

May 20, 2019 updated by: M.D. Anderson Cancer Center
The goal of this research study is to improve detection of cancer outside of the bladder through genetic testing and improved imaging.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants scheduled for bladder cancer surgery and biopsy from the Department of Urology at MD Anderson Cancer Center in Houston, Texas.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2014

Primary Completion (Actual)

May 16, 2019

Study Completion (Actual)

May 16, 2019

Study Registration Dates

First Submitted

July 25, 2014

First Submitted That Met QC Criteria

July 28, 2014

First Posted (Estimate)

July 29, 2014

Study Record Updates

Last Update Posted (Actual)

May 22, 2019

Last Update Submitted That Met QC Criteria

May 20, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA13-0942

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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