NCT03857477

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,700 (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. 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.

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 were recruited via participating General Practices (GPs). The full study aimed to recruit an additional 4700 participants. Men aged 55-69 years who were likely to be eligible for the study were identified by GPs from medical records. Participants were contacted via invitation letters from GPs and if interested in the study were asked to sign a consent form and complete a questionnaire to confirm eligibility to participate. If eligible, men were then sent a DNA collection saliva kit. DNA from saliva was 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 470 men in total from the full study) were invited for an MRI and a transperineal (TP) prostate biopsy under local anaesthetic (LA), plus further biological samples. Biopsy results will be correlated with the genetic score. The study also aims to determine the incidence and aggressiveness of prostate cancer in men within the top 10% of the genetic score. Furthermore, the association of MRI appearance and biological sample biomarker profile with prostate biopsy result in men at genetically higher prostate cancer risk undergoing targeted screening will also be determined.

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	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.

Timeline

• Start date: 2019-03-14
• Primary completion: 2024-04-01
• Completion: 2028-12-31
• First posted: 2019-02-28
• Last updated: 2025-04-29

Locations

1 site across 1 country: United Kingdom