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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02203136
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : May 22, 2019
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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