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

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ClinicalTrials.gov Identifier: NCT02203136
Recruitment Status : Active, not recruiting
First Posted : July 29, 2014
Last Update Posted : August 2, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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

Condition or disease Intervention/treatment
Bladder Cancer Procedure: Tissue Biopsy Procedure: Magnetic Resonance Imaging (MRI)

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.


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Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Clinical Staging for Muscle Invasive Bladder Cancer Through Molecular Profiling and Improved Imaging
Actual Study Start Date : June 25, 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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 Name: MRI




Primary Outcome Measures :
  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.


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203136


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Neema Navai, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02203136     History of Changes
Other Study ID Numbers: PA13-0942
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018

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

Keywords provided by M.D. Anderson Cancer Center:
Bladder cancer
Muscle invasive bladder cancer
MIBC
Biopsy specimen molecular profiling
Bladder surgery
Magnetic resonance imaging
MRI
Trans urethral resection of bladder

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases