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

M.D. Anderson Cancer Center

Status: Completed

Conditions: Bladder Cancer

Treatments: Procedure: Tissue Biopsy; Procedure: Magnetic Resonance Imaging (MRI)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02203136

PA13-0942

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

16 participants in 1 patient group

Muscle Invasive Bladder Cancer (MIBC)

Description:

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.

Treatment:

Procedure: Magnetic Resonance Imaging (MRI)

Procedure: Tissue Biopsy