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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02203136
Enrollment
16
Registered
2014-07-29
Start date
2014-06-25
Completion date
2019-05-16
Last updated
2019-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

PROCEDURETissue Biopsy

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

PROCEDUREMagnetic Resonance Imaging (MRI)

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Detection Improvement of Cancer Outside of the Bladder4 weeksImproved 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026