The BARCODE 1 Pilot Study (BARCODE1Pilot)

Institute of Cancer Research, United Kingdom

Status

Active, not recruiting

Conditions

Prostate Cancer

Treatments

Procedure: Prostate biopsy

Other: Prostate cancer screening

Genetic: Genetic SNP profiling

Study type

Observational

Funder types

Other

Identifiers

NCT03158922

CCR4130

Details and patient eligibility

About

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.

Full 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.

Enrollment

329 patients

Sex

Male

Ages

55 to 69 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Men aged 55-69 years
Caucasian ethnicity
World Health Organisation (WHO) performance status 0-2
Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule

Exclusion criteria

Non-Caucasian ethnicity (including mixed race or Jewish)
Previous diagnosis of cancer with a life-expectancy of less than five years
Prostate biopsy in the past year
Previous diagnosis of prostate cancer
Co-morbidities making prostate biopsy risk unacceptable (anticoagulants or antiplatelet medication like Warfarin or Clopidogrel, poorly controlled diabetes or cardiovascular disease)