Glycosylation of Exosomes in Prostate and Urothelial Carcinoma

Terminated

• Conditions: Urothelial Carcinoma; Prostate Cancer

• Registration Number: NCT04960956
• Lead Sponsor: Indiana University

Brief 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.

Detailed 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 Timeline

• Study Start: 2016-10-13
• Primary Completion: 2017-02-02
• Study Completion: 2017-02-02
• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-09
• Study First Posted: 2021-07-14
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-25
• Last Update Posted: 2022-03-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 13

Inclusion Criteria

1. Males ≥ 18 years old at the time of informed consent

2. Ability to provide written informed consent and HIPAA authorization

3. Willingness to donate a fasting urine sample for research Patient Cohort

   1. Histologically confirmed prostate or urothelial carcinoma
   2. Localized disease
   3. No neoadjuvant chemotherapy for disease Healthy Volunteer Cohort
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   1. Healthy volunteers must not have prostate or urothelial carcinoma

Exclusion Criteria

1. Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety
2. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The concentration of urine spermine in the diagnosis of prostate and urothelial cancer	Baseline (one-time point)	xFresh urine will be collected for MALDI-TOF analysis to detect the concentration of exosome-derived glycans in the urine sample

Trial Locations

Locations (1)

Indiana University Melvin & Bren Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States