Brief Title
Glycosylation of Exosomes in Prostate and Urothelial Carcinoma
Official Title
Glycosylation of Exosomes in Prostate and Urothelial Carcinoma
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 Type
Observational
Primary Outcome
The concentration of urine spermine in the diagnosis of prostate and urothelial cancer
Condition
Prostate Cancer
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
13
Start Date
October 13, 2016
Completion Date
February 2, 2017
Primary Completion Date
February 2, 2017
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
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
Gender
Male
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Roberto Pili, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04960956
Organization ID
IUSCC-0588
Responsible Party
Principal Investigator
Study Sponsor
Indiana University
Study Sponsor
Roberto Pili, MD, Principal Investigator, Indiana University School of Medicine, Indiana University Simon Cancer Center
Verification Date
February 2022