BARCODE 1 Pilot Study
Research type
Research Study
Full title
BARCODE 1 pilot study: The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening
IRAS ID
147536
Contact name
Rosalind Eeles
Contact email
Sponsor organisation
The Institute of Cancer Research
Clinicaltrials.gov Identifier
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 40,000 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 pilot study has been developed to investigate how to use this knowledge to target PCa screening within the general population.\n\nWe will invite 300 men from London in this pilot to 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). This study will eventually be expanded to a full study of 5000 men.\n\nWe 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.\n\nMen 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
15/LO/1992
Date of REC Opinion
26 Jan 2016
REC opinion
Further Information Favourable Opinion