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Clinical Trial Summary

The purpose of this study is to collect a urine sample from patients with prostate and urothelial (bladder) cancer and healthy volunteers who do not have cancer, so that researchers can perform studies on microcellular structures called exosomes that may eventually lead to a new type of urinary biomarker test for prostate and urothelial cancer.


Clinical Trial Description

This is a one-time participation, banking study of up to 40 subjects (10 prostate, 10 urothelial, 20 without cancer). Subjects must meet eligibility at the time of informed consent and will donate approx. 200mL of urine sample. Primary Objective: To develop alternative and efficient urinary exosome isolation and glycan analysis approaches for especially large glycan structures, including their isomers present at low levels, which will particularly enhance current analytical technology. To provide further testing of the current microfluidic-based approaches developed to screen glycan samples which this additional specimen will provide to assess whether the current analytical techniques are robust enough to handle this type of sample with sufficient resolution and sensitivity for useful analytical information. To compare alterations in exosome-derived glycans in adults with prostate and urothelial carcinoma in comparison with the exosome-derived glycans in age-matched healthy adults for assessment of findings to explore if the tools could be applied for future study toward a liquid biopsy test. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04960956
Study type Observational
Source Indiana University
Contact
Status Suspended
Phase
Start date October 13, 2016
Completion date January 31, 2026

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