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Caucasian men aged 55-69 to undergo genetic profiling.

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

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

Genetic SNP profiling

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.

Prostate cancer screening

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

Prostate biopsy

Rosalind A Eeles, FRCP, FRFR

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.

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.

The BARCODE 1 Pilot Study

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

Anonymised data can be applied for via the Data Access Committee.

Institute of Cancer Research, United Kingdom

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Caucasian men aged 55-69 to undergo genetic SNP profiling.

Men from Stage 1 identified as having a higher genetic risk score (top 10%) for prostate cancer will be offered an MRI scan, prostate biopsy and prostate cancer screening.

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

MRI Scan

Transperineal prostate biopsy under local anaesthetic will be offered to men identified within the top 10% genetic risk score profile.

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.

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.

Eligible participants must be of male gender at birth.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The BARCODE 1 Pilot Study	NCT03158922	Prostate Cancer	Genetic SNP pro... Prostate cancer... Prostate biopsy	55 Years - 69 Years	Institute of Cancer Research, United Kingdom
The BARCODE 1 Pilot Study	NCT03158922	Prostate Cancer	Genetic SNP pro... Prostate cancer... Prostate biopsy	55 Years - 69 Years	Institute of Cancer Research, United Kingdom
The BARCODE 1 Study (Full Study): The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening.	NCT03857477	Prostate Cancer	Genetic SNP pro... Prostate cancer... MRI Scan Prostate biopsy	55 Years - 69 Years	Institute of Cancer Research, United Kingdom

Spots Global Cancer Trial Database for genetic snp profiling