PSA Glycomics Assay for Early Detection of Prostate Cancer

NCT ID: NCT04393376

Last Updated: 2023-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2025-08-01

Brief Summary

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The principal aim of this pilot study is to test whether the PSA Glycomics Assay on urine and serum samples can provide insights regarding the disease state of patients with elevated PSA concentrations, as well as to accurately identify if the patient has prostate cancer and, in the case of prostate cancer, to determine its level of aggressiveness.

Detailed Description

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Conditions

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Prostate Cancer PSA

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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PSA Glycomics Assay

PSA Glycomics Assay will be performed on urine and blood samples

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients with elevated PSA (\>3 ng/mL)
* Signed informed consent

Exclusion Criteria

* Patients that have a cystitis (bladder infection)
* Patients under chemotherapy
* Patients using 5-alpha reductase inhibitors
* History or presence of cancers, or non-prostate urological disorders.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role collaborator

The Netherlands Cancer Institute

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role collaborator

Leiden University Medical Center

OTHER

Sponsor Role collaborator

Prof.dr. H.P. Beerlage

OTHER

Sponsor Role lead

Responsible Party

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Prof.dr. H.P. Beerlage

Urologist, Head of Department of Urology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Amsterdam UMC, location AMC

Amsterdam, North Holland, Netherlands

Site Status COMPLETED

Amsterdam UMC, location VUmc

Amsterdam, , Netherlands

Site Status RECRUITING

Leiden University Medical Centre

Leiden, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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J R Oddens, MD, PhD

Role: CONTACT

+31(0)20-5668637

Facility Contacts

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J.R. Oddens, MD, PhD

Role: primary

Guinevere Kammeijer, MD, PhD

Role: primary

Other Identifiers

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NL73261.018.20

Identifier Type: -

Identifier Source: org_study_id

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