Clinical trial NCT04960956: Glycosylation of Exosomes in Prostate and Urothelial Carcinoma
Official title: Glycosylation of Exosomes in Prostate and Urothelial Carcinoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Urothelial Carcinoma
Keywords: Glycosylation
Urinary Exosomes
Exosome-derived Glycans
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males ≥ 18 years old at the time of informed consent

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.

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

Primary outcomes:
measure: The concentration of urine spermine in the diagnosis of prostate and urothelial cancer
timeFrame: Baseline (one-time point)
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin & Bren Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine, Indiana University Simon Cancer Center
name: Roberto Pili, MD
role: PRINCIPAL_INVESTIGATOR
References: