Biomarker Identification for Bladder Cancer Patients

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2022

Interventions

  • Procedure: Sample Collection
    • A 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.

Arms, Groups and Cohorts

  • Bladder Cancer Patients
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Identify novel biomarkers for bladder cancer
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ohio State University Comprehensive Cancer Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Arnab Chakravarti, Principal Investigator – Ohio State University Comprehensive Cancer Center
  • Overall Official(s)
    • Arna Chakravarti, MD, Principal Investigator, The Ohio State University Cancer Center

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