Biomarker Identification for Bladder Cancer Patients

Bladder Cancer Clinical Trial

Official title:

Biomarker Identification for Bladder Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02053662
• Other study ID #: OSU-12158
• Status: Active, not recruiting
• Start date: January 21, 2014
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2021
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 179
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	The Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify novel biomarkers for bladder cancer	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.	up to 5 years

External Links

•   The Jamesline