STHLM3 - Prostate Cancer Diagnostic Trial

NCT ID: NCT03639649

Last Updated: 2018-08-21

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

Clinical Phase

NA

Total Enrollment

58818 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-02-28

Brief Summary

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STHLM3 is a paired diagnostic trial aiming to assess whether a panel of biomarkers for prostate cancer can substantially reduce the proportion of men referred to biopsy whilst maintaining sensitivity for aggressive prostate cancer

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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STHLM3

Group Type EXPERIMENTAL

STHLM3

Intervention Type DIAGNOSTIC_TEST

PSA

Group Type ACTIVE_COMPARATOR

STHLM3

Intervention Type DIAGNOSTIC_TEST

Interventions

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STHLM3

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age 50-69
* Residential address in Stockholm County

Exclusion Criteria

* Previous Prostate Cancer Diagnosis
* Not able to comprehend inform consent material
Minimum Eligible Age

50 Years

Maximum Eligible Age

69 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Henrik Grönberg

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Karolinska Institutet

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Karolinska1

Identifier Type: -

Identifier Source: org_study_id

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