NCT03158922

The BARCODE 1 Pilot Study

The BARCODE 1 Pilot Study: The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 329 (actual)
• Sponsor: Institute of Cancer Research, United Kingdom · Academic / Other
• Sex: Male
• Age: 55 Years – 69 Years
• Healthy volunteers: Accepted

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.

Detailed description

The BARCODE 1 study aims to evaluate genetic profiling using the known 170 prostate cancer (PrCa) risk single-nucleotide polymorphisms (SNPs) as a means of offering targeted screening for PrCa in men at a genetically higher risk. Initially, 300 men will be recruited via participating General Practices (GPs). Men aged 55-69 years who are likely to be eligible for the study will be identified by GPs from medical records. Participants will be contacted via invitation letters from GPs and if interested in the study will be asked to fill in a questionnaire to confirm eligibility to participate. This questionnaire can be completed in hard copy and men will also be given the option to fill in an online version. If eligible, men will then be sent a DNA collection saliva kit. DNA from saliva will be analysed with SNP profiling for the known 170 clinically relevant SNPs. Men with a genetic risk equivalent to the top 10% of the population distribution (approximately 30 men in total) will be invited for a transrectal ultrasound (TRUS) prostate biopsy, plus further biological samples. Biopsy results will be correlated with the genetic score. Prostate-specific antigen (PSA) and other biomarkers will be integrated into results to assess combined effects of genetic score and markers.

Conditions

• Prostate Cancer

Interventions

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

Timeline

• Start date: 2016-04-29
• Primary completion: 2018-04-14
• Completion: 2028-12-31
• First posted: 2017-05-18
• Last updated: 2025-09-26

Locations

1 site across 1 country: United Kingdom