PSA Glycomics Assay for Early Detection of Prostate Cancer | NCT04393376

Studies
PSA Glycomics Assay for Early Detection of Prostate Cancer

NCT04393376

Sponsor

Prof.dr. H.P. Beerlage

Status

Unknown status

Last Update Posted

Sep 26, 2023Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Prostate Cancer
PSA

Interventions

PSA Glycomics Assay

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Actual

Primary Completion Date

Jan 1, 2024Estimated

Completion Date

Aug 1, 2025Estimated

First Submitted Date

May 14, 2020

First Submission Date that Met QC Criteria

May 14, 2020

First Posted Date

May 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2023

Last Update Posted Date

Sep 26, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof.dr. H.P. Beerlage, Urologist, Head of Department of Urology, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Sponsor-Investigator

Lead Sponsor

Prof.dr. H.P. BeerlageOTHER

Collaborators

Name	Class
Amsterdam UMC, location VUmc	OTHER
The Netherlands Cancer Institute	OTHER
Radboud University Medical Center	OTHER
Leiden University Medical Center

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PSA Glycomics Assay	Diagnostic Test	PSA Glycomics Assay will be performed on urine and blood samples

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PSA Glycomics Assay	The relative abundance of glycoforms of PSA in plasma and urine from the subjects will be measured. These will be related to the stage of PCa and compared to non-prostate cancer patients.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
J R Oddens, MD, PhD	Contact	+31(0)20-5668637		j.r.oddens@amsterdamumc.nl

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Amsterdam UMC, location AMC	Completed	Amsterdam	North Holland	1105 AZ	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided