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NCT04583072 · ClinicalTrials.gov registry record
Stockholm3 Validation Study in a Multi-Ethnic Cohort
A clinical trial of Prostate Cancer (Diagnosis), sponsored by Karolinska Institutet.
- Completed
- Registry status
- 2,152
- Enrollment target
- 14
- Study locations
NCT04583072 is a study of Prostate Cancer (Diagnosis) that has completed, run by Karolinska Institutet. The registered enrollment target is 2,152 participants, above the 453-participant average among 5 other Prostate Cancer (Diagnosis) trials with a reported enrollment target (375% higher). The trial reports 14 study locations across 5 states.
The verdict
NCT04583072, a study of Prostate Cancer (Diagnosis), has completed, sponsored by Karolinska Institutet.
- COMPLETED
- Registry status
- 2,152 participants
- Enrollment target
- 14
- Study locations
Study Summary
Introduction: Prostate cancer (PCa) is the most commonly detected cancer in men and is the second leading cause of cancer death. Differences in race and ethnicity have been shown to have differences in PCa incidence, detection, and outcomes. Current prostate cancer screening involves prostatic specific antigen (PSA) which is a nonspecific protein marker (aka kallikrein) that can often leads to unnecessary biopsies (up to 74% benign biopsies) and clinical overdiagnosis (with up to 22% clinically insignificant cancer). Recently more sophisticated tests have been developed for PCa screening in the United States such as the Prostate Health Index (PHI) and the 4k (kallikrein) score, as well as clinical models that use information from the patient clinical history. However, these tests utilize limited serum protein assays and none of the established screening protocols utilize genetic variables to help account for the likely inherited risks as seen in different ethnicities. A recent Swedish, prospective, population-based study, published in the Lancet Oncology, developed a unique multivariable biopsy outcome prediction model within a Nordic population of nearly 60,000 men. This model, the Stockholm3, which incorporated plasma protein markers, germline DNA SNPs as well as clinical variables, was shown to be capable of reducing the number of biopsies by 44% compared to PSA while maintaining adequate sensitivity for detection of PCa. It is unknown whether an approach developed in Sweden that incorporates protein markers, genetics, clinical variables, and genetic ancestry would be beneficial in a racially diverse cohort. Hypothesis: The investigators hypothesize that, a prospectively studied multiethnic cohort of men with the Stockholm3 test will identify unique and common risk factors that improve prostate cancer detection. Aim: To assess the performance of the Stockholm3 test as compared to PSA and to identify unique features associated with PCa in Black/African America
Conditions Studied
Interventions
- DIAGNOSTIC_TEST The Stockholm3 test
Study Locations (14)
Illinois
- Northwestern Medicine - Chicago
- John H. Stroger, Jr. Hospital of Cook County - Chicago
- Rush University Medical Center - Chicago
- University of Illinois at Chicago - Chicago
- Cook County Health System - Chicago
- University of Chicago - Chicago
- Uropartners - Westchester
California
- Los Angeles County - Los Angeles
- University of Southern California - Los Angeles
- Stanford University - Palo Alto
Texas
- Urology Clinics of North Texas - Dallas
- University of Texas Health Science Center San Antonio - San Antonio
New York
- Montefiore Medical Center - The Bronx
Ontario
- University Health Network - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,152 participants |
| Start Date | 2019-12-15 |
| Est. Completion | 2023-07-15 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04583072
The ClinicalTrials.gov registry entry for NCT04583072 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 2,152 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 453-participant average among 5 other Prostate Cancer (Diagnosis) trials with a reported enrollment target (375% higher). The listed sponsor is Karolinska Institutet, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostate Cancer (Diagnosis) appearing as the primary indexed condition, and to 1 intervention - of which The Stockholm3 test is the first listed.
NCT04583072 reports 14 study locations spanning 5 distinct geographic areas - top geographies include Illinois, California, Texas.
Frequently Asked Questions
What is clinical trial NCT04583072 about?
NCT04583072 is a clinical study titled "Stockholm3 Validation Study in a Multi-Ethnic Cohort". Introduction: Prostate cancer (PCa) is the most commonly detected cancer in men and is the second leading cause of cancer death. Differences in race and ethnicity have been shown to have differences in PCa incidence, detection, and outcomes. Current prostate cancer screening involves prostatic speci...
What is the current status of trial NCT04583072?
This trial is currently completed. The enrollment target is 2,152 participants. The study started on 2019-12-15. Estimated completion is 2023-07-15.
What conditions does trial NCT04583072 study?
This clinical trial studies the following conditions: Prostate Cancer (Diagnosis).
What interventions are being tested in trial NCT04583072?
The interventions under investigation include: The Stockholm3 test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04583072?
This trial is sponsored by Karolinska Institutet, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04583072 being conducted?
This trial has 14 study locations across California, Illinois, New York, Texas, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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