Glycosylation of Exosomes in Prostate and Urothelial Carcinoma

NCT ID: NCT04960956

Last Updated: 2022-03-14

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-13
• Study Completion Date: 2017-02-02

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.

Conditions

Prostate Cancer; Urothelial Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Roberto Pili

Associate Dean for Cancer Research and Integrative Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Pili, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine, Indiana University Simon Cancer Center

Locations

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

IUSCC-0588

Identifier Type: -

Identifier Source: org_study_id