The BARCODE 1 Study
Research type
Research Study
Full title
BARCODE 1 study: The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening.
IRAS ID
257684
Contact name
Rosalind Eeles
Contact email
Sponsor organisation
The Institute of Cancer Research
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
20190, Central Portfolio Management System (CPMS); 13598, Cancer Research UK (CRUK) internal database number
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Prostate cancer (PCa) is the most common cancer in men in the UK with over 47,700 men diagnosed each year. Growing knowledge about the contribution of genes to the development of PCa has allowed us to develop a ‘genetic profile’ to predict which men are at an increased risk of the disease. The BARCODE 1 study has been developed to investigate how to use this knowledge to target PCa screening within the general population.
A pilot of 300 men were recruited aiming to inform the feasibility and acceptability of the study approach. This protocol is for the main study, aiming to extend the study to the total planned population of 5000 men.These men will undergo testing for known single nucleotide polymorphisms (SNPs) that predispose to PCa. This test is the genetic profile. We will offer a prostate biopsy to those who fall in the top 10% of the risk profile (30 men).
We aim to examine how many men in the top 10% risk group go on to develop PCa, compared with men in previous studies who are known not to be high risk. We will also look at the utility of prostate-specific antigen (PSA) screening in this top 10% risk group, as well as the frequency of more aggressive PCa in this group. This knowledge will help determine if a genetic profile is useful in targeting PCa screening to the men in the general population who would most benefit.
Men will also be invited to participate in a questionnaire-based sub-study to evaluate the psychosocial and behavioural impact of this genetic profile in the general population. This will be to deduce the information needs of men undergoing this type of genetic testing and to inform the development of decision tools to aid men deciding about this type of testing in the future.
REC name
London - Chelsea Research Ethics Committee
REC reference
18/LO/2166
Date of REC Opinion
22 Jan 2019
REC opinion
Favourable Opinion