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

NCT ID: NCT05294627

Last Updated: 2023-12-12

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

COMPLETED

Total Enrollment

380 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-10-01

Brief Summary

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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

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Conditions

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Prostate Cancer Localized Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Stockholm3

Stockholm3 test prior to prostate biopsy. Prostate biopsy is preformed irrespective of the Stockholm3 score.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Department of Urology, University Hospital Freiburg, Freiburg, Germany

UNKNOWN

Sponsor Role collaborator

Department of Urology, Kantonsspital Graubünden, Chur, Switzerland

UNKNOWN

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashkan Mortezavi

Role: PRINCIPAL_INVESTIGATOR

Universitätsspital Basel

Locations

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University Hospital Basel, Urology

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Stockholm3

Identifier Type: -

Identifier Source: org_study_id