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

NCT02203136 | Completed

• 1 other identifier: PA13-0942
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bladder Cancer

Keywords

Bladder cancer; Muscle invasive bladder cancer; MIBC; Biopsy specimen molecular profiling; Bladder surgery; Magnetic resonance imaging; MRI; Trans urethral resection of bladder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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; Procedure: Magnetic Resonance Imaging (MRI)

Interventions

Tissue Biopsy PROCEDURE

During bladder cancer surgery, tissue specimen taken for molecular profiling.

Muscle Invasive Bladder Cancer (MIBC)

Magnetic Resonance Imaging (MRI) PROCEDURE

3 Tesla pelvic magnetic resonance imaging (MRI) performed four weeks after bladder cancer surgery.

Also known as: MRI

Muscle Invasive Bladder Cancer (MIBC)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Neema Navai, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2014
• First Posted: July 29, 2014
• Study Start: June 25, 2014
• Primary Completion: May 16, 2019
• Study Completion: May 16, 2019
• Last Updated: May 22, 2019

Record last verified: 2019-05

Locations

US (1)