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The BARCODE 1 Study (Full Study): The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening.

NCT03857477 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 4700

Last updated 2025-04-29

No results posted yet for this study

Summary

BARCODE 1 is a screening study designed to investigate the role of genetic profiling for targeting population prostate cancer screening. A pilot of 300 men were recruited aiming to inform the feasibility and accessibility of the study approach. The full study is an extension of the pilot study aiming to recruit a total of 5000 men.

Conditions

Interventions

GENETIC

Genetic SNP profiling

Genetic SNP profiling of known prostate cancer predisposition SNPs will be performed on DNA extracted from saliva samples.

OTHER

Prostate cancer screening

Prostate cancer screening in the form of PSA testing will be offered to all men who have a benign biopsy result for five years in order to track development of cancer in the future.

PROCEDURE

MRI Scan

MRI scan will be offered to men identified within the top 10% genetic risk score profile.

PROCEDURE

Prostate biopsy

Transperineal prostate biopsy under local anaesthetic will be offered to men identified within the top 10% genetic risk score profile.

Sponsors & Collaborators

  • Institute of Cancer Research, United Kingdom

    lead OTHER

Principal Investigators

  • Rosalind A Eeles, FRCP, FRFR · Institute of Cancer Research and Royal Marsden Hospital

Eligibility

Min Age
55 Years
Max Age
69 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-14
Primary Completion
2024-04-01
Completion
2028-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03857477 on ClinicalTrials.gov