Glycosylation of Exosomes in Prostate and Urothelial Carcinoma

NCT04960956 | Terminated DMC

• 1 other identifier: IUSCC-0588
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Urothelial Carcinoma

Keywords

Glycosylation; Urinary Exosomes; Exosome-derived Glycans

Outcome Measures

Primary Outcomes (1)

• The concentration of urine spermine in the diagnosis of prostate and urothelial cancer

  xFresh urine will be collected for MALDI-TOF analysis to detect the concentration of exosome-derived glycans in the urine sample

  Baseline (one-time point)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males ≥ 18 years old at the time of informed consent

You may qualify if:

• Males ≥ 18 years old at the time of informed consent
• Ability to provide written informed consent and HIPAA authorization
• Willingness to donate a fasting urine sample for research Patient Cohort
• Histologically confirmed prostate or urothelial carcinoma
• Localized disease
• No neoadjuvant chemotherapy for disease Healthy Volunteer Cohort
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• Healthy volunteers must not have prostate or urothelial carcinoma

You may not qualify if:

• 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
• Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine sample collection, handling, and storage requirements * Collect at least 40-50 mL of fresh fasting urine (Note: up to 200 mL from each subject can be used for this study) * Within two hours of collection, add one tablet containing protease inhibitor cocktail and 0.5 mL of 2% sodium azide solution (weight to volume in water) to the sample for preventing bacterial growth (both additives provided by the Novotny Glycoscience Laboratory). Close the cap and mix gently by hand until the additives have dispersed into the urine sample. * Label the sample with the study ID, subject ID, date and time of collection * Store at -80°C * Batch-ship samples on dry ice to: Professor Milos Novotny IU Department of Chemistry 800 E. Kirkwood Ave. Bloomington, IN 47405 Phone: 812-855-4532

MeSH Terms

Conditions

Prostatic Neoplasms; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Roberto Pili, MD

  Indiana University School of Medicine, Indiana University Simon Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean for Cancer Research and Integrative Oncology

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 14, 2021
• Study Start: October 13, 2016
• Primary Completion: February 2, 2017
• Study Completion: February 2, 2017
• Last Updated: March 14, 2022

Record last verified: 2022-02

Locations

US (1)