The BARCODE 1 Pilot Study

NCT03158922 | Active Not Recruiting DMC

• 1 other identifier: CCR4130
• Study Type: observational
• Target: 329
• Locations: 1 country
• Sites: 1

Brief Summary

BARCODE 1 is a screening study designed to investigate the role of genetic profiling for targeting population prostate cancer screening. This study forms a pilot of 300 men, with the view to continue to a future study of 5000 men.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Association of SNP genetic risk score with prostate biopsy results.

  5 years

Secondary Outcomes (3)

• Incidence and aggressiveness of PrCa in men within the top 10% of the genetic score.

  5 years

• Association of the biomarker profile with genetic score and biopsy results.

  5 years

• Use of genetic profiling to target prostate cancer screening in a clinical environment.

  5 years

Study Arms (2)

Stage 1

Caucasian men aged 55-69 to undergo genetic profiling.

Genetic: Genetic SNP profiling

Stage 2

Men from Stage 1 identified as having a higher genetic risk score (top 10%) for prostate cancer.

Genetic: Genetic SNP profiling; Other: Prostate cancer screening; Procedure: Prostate biopsy

Interventions

Genetic SNP profiling GENETIC

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

Stage 1; Stage 2

Prostate cancer screening OTHER

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.

Stage 2

Prostate biopsy PROCEDURE

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

Also known as: TRUS Biopsy

Stage 2

Eligibility Criteria

• Age: 55 Years - 69 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men of Caucasian ethnicity (not Mixed race or Jewish), aged 55 - 69 years, willing to undergo genetic SNP profiling.

You may qualify if:

• Men aged 55-69 years
• Caucasian ethnicity
• World Health Organisation (WHO) performance status 0-2
• Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule

You may not qualify if:

• Non-Caucasian ethnicity (including mixed race or Jewish)
• Previous diagnosis of cancer with a life-expectancy of less than five years
• Prostate biopsy in the past year
• Previous diagnosis of prostate cancer
• Co-morbidities making prostate biopsy risk unacceptable (anticoagulants or antiplatelet medication like Warfarin or Clopidogrel, poorly controlled diabetes or cardiovascular disease)

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead

Study Sites (1)

Institute of Cancer Research and Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva, blood, urine

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Rosalind A Eeles, FRCP, FRFR

  Institute of Cancer Research and Royal Marsden Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 18, 2017
• Study Start: April 29, 2016
• Primary Completion: April 14, 2018
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)