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OpenTrials
Completed

NCT Number: NCT02203136

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

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

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Tissue biopsy

Procedure

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

Magnetic Resonance Imaging (MRI)

Procedure

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

Other names: MRI

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 29, 2014
Registry last updated
May 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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