Biomarker Identification for Bladder Cancer Patients

Terminated

• Conditions: Bladder Cancer
• Interventions: Procedure: Sample Collection

• Registration Number: NCT02053662
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

To develop a simple blood and urine test that we would perform before patients start their treatment to predict the risk that their bladder cancer might come back. To develop this test the investigators plan to analyze blood, urine and cancer tissue from bladder cancer patients and follow them closely during and after treatment. This will include looking for changes in proteins and genes that might play a role in bladder cancer biology. The investigators will then compare the information obtained from the studies of blood, urine and cancer tissue between patients that are cured and those whose cancer comes back. The knowledge about these differences between patients can then potentially be used to develop a blood or urine test to tell us who has a high risk for having bladder cancer come back.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-21
• Study First Submitted: 2014-01-30
• Study First Submitted QC: 2014-01-31
• Study First Posted: 2014-02-04
• Primary Completion: 2023-11-16
• Study Completion: 2023-11-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 179

Inclusion Criteria

• Adult patients ≥18 years old.
• Patients suspected, clinically diagnosed, or histologically diagnosed bladder cancer.
• Patients undergoing cystoscopy without cancer suspicion.
• Ability to give an informed consent.

Exclusion Criteria

• Patients receiving concurrent therapy for a second malignancy.
• < 18 years old.
• Inability to give an informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bladder Cancer Patients	Sample Collection	Patients with muscle invasive bladder cancer. A sample collection of donated cancer and normal adjacent tissues, blood and urine which will be prospectively obtained from patients through the Tissue Procurement Shared Resources (TPSR) and The Ohio State University Comprehensive Cancer Center Biospecimen and Biorepository Resource (BBR) as needed.

Primary Outcome Measures

Name	Time	Method
Identify novel biomarkers for bladder cancer	up to 5 years	Predict and detect bladder cancer recurrence, specifically through development of biomarkers using bladder cancer tissue samples as well as blood and urine samples. Detect the recurrence of disease through development of blood and urine biomarkers using pre-therapy and post-therapy biospecimens.

Trial Locations

Locations (1)

The Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States