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

• ClinicalTrials.gov Identifier: NCT02203136
• Recruitment Status: Completed
• First Posted: July 29, 2014
• Last Update Posted: May 22, 2019
• Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Tracking Information

• First Submitted Date: July 25, 2014
• First Posted Date: July 29, 2014
• Last Update Posted Date: May 22, 2019
• Actual Study Start Date: June 25, 2014
• Actual Primary Completion Date: May 16, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 28, 2014)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Improving Clinical Staging for Muscle Invasive Bladder Cancer Through Molecular Profiling and Improved Imaging
• Official Title: Improving Clinical Staging for Muscle Invasive Bladder Cancer Through Molecular Profiling and Improved Imaging
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

At the time of biopsy, a portion of the fresh human tumor biopsy samples utilized for DNA and RNA extraction.

• 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.
• Condition: Bladder Cancer

Intervention

• 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

Study Groups/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.

Interventions:

• Procedure: Tissue Biopsy
• Procedure: Magnetic Resonance Imaging (MRI)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 31, 2018): 16
• Original Estimated Enrollment (submitted: July 28, 2014): 100
• Actual Study Completion Date: May 16, 2019
• Actual Primary Completion Date: May 16, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02203136
• Other Study ID Numbers: PA13-0942
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: M.D. Anderson Cancer Center
• Study Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Neema Navai, MD; M.D. Anderson Cancer Center

• PRS Account: M.D. Anderson Cancer Center
• Verification Date: May 2019