Validation of the Stockholm3 Test for Detection of Prosta... | NCT05294627

Studies
Validation of the Stockholm3 Test for Detection of Prostate Cancer in the Swiss Population

NCT05294627

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Dec 12, 2023Actual

Enrollment

380Actual

Phase

Not provided

Conditions

Prostate Cancer
Localized Carcinoma

Interventions

Stockholm3

Countries

Switzerland

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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Nov 1, 2022Actual

Completion Date

Oct 1, 2023Actual

First Submitted Date

Mar 14, 2022

First Submission Date that Met QC Criteria

Mar 23, 2022

First Posted Date

Mar 24, 2022Actual

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

Dec 11, 2023

Last Update Posted Date

Dec 12, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

University Hospital, Basel, SwitzerlandOTHER

Collaborators

Name	Class
Department of Urology, University Hospital Freiburg, Freiburg, Germany	UNKNOWN
Department of Urology, Kantonsspital Graubünden, Chur, Switzerland	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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 purpose of this study is to collect blood samples to investigate the prognostic performance of the STHLM3 test in a population of Swiss and German men suspected of harbouring prostate cancer based on a combination of elevated PSA levels (e.g. >2.5 ng/ml) and/or pathological digital rectal examination and/or MRI-findings.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

380Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stockholm3	Diagnostic Test	Stockholm3 test prior to prostate biopsy. Prostate biopsy is preformed irrespective of the Stockholm3 score.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cancer detection	Correlation between Stockholm3 and histological diagnosis of prostate cancer	2020-2022

Secondary Outcomes

Measure	Description	Time Frame
Disease state	Correlation between Stockholm3 and clinical disease stage	2020-2022

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Planned prostate biopsy due to suspicion of prostate cancer (usually due to a combination of elevated PSA levels [e.g. >2.5 ng/ml] and/or pathological digital rectal examination and/or MRI-findings)
Written informed consent by the participant

Exclusion Criteria:

Severe anemia (Hb <60g/l)
Previously already established diagnosis of prostate cancer.

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Men with suspicion of prostate cancer (usually due to a combination of elevated PSA levels [e.g. >2.5 ng/ml] and/or pathological digital rectal examination and/or MRI-findings)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ashkan Mortezavi	Universitätsspital Basel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Basel, Urology		Basel		4031	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

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