Prostate CancerNCT04960956
Glycosylation of Exosomes in Prostate and Urothelial Carcinoma
An observational study of Prostate Cancer and Urothelial Carcinoma, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Urothelial Carcinoma
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2016to 2 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males ≥ 18 years old at the time of informed consent
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
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.
Read the 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
- Keywords
- Glycosylation, Urinary Exosomes, Exosome-derived Glycans
- Medical subject headings
- Prostatic Neoplasms, Carcinoma, Transitional Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (one-time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start13 Oct 2016
- Primary completion2 Feb 2017
- Study completion2 Feb 2017
Why it stopped: Could not identify a replacement Principal Investigator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Pili, University at Buffalo
- Investigators
- Roberto Pili, MD, Principal investigator, Indiana University School of Medicine, Indiana University Simon Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960956
- Sponsor's protocol ID
- IUSCC-0588
- Status last verified
- Feb 2022
- First submitted
- 9 Jul 2021
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycosylation of Exosomes in Prostate and Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT04960956
- Acronym / sponsor ID
- IUSCC-0588
- Conditions
- Prostate Cancer, Urothelial Carcinoma
- Keywords
- Glycosylation, Urinary Exosomes, Exosome-derived Glycans
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Could not identify a replacement Principal Investigator.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 13 Oct 2016 (actual)
- Primary completion
- 2 Feb 2017 (actual)
- Study completion
- 2 Feb 2017 (actual)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males ≥ 18 years old at the time of informed consent
Key inclusion criteria (8 listed)
- 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
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Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The concentration of urine spermine in the diagnosis of prostate and urothelial cancer
Time frame: 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
Results and safety
The study was stopped early (reason given: Could not identify a replacement Principal Investigator.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Pili, MD principal investigator
Indiana University School of Medicine, Indiana University Simon Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Urothelial Carcinoma, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Could not identify a replacement Principal Investigator.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concentration of urine spermine in the diagnosis of prostate and urothelial cancer (time frame: Baseline (one-time point)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.