Clinical trial NCT03158922: The BARCODE 1 Pilot Study
Official title: The BARCODE 1 Pilot Study: The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Lead sponsor: Institute of Cancer Research, United Kingdom
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 329
Sex: MALE
Minimum age (years): 55
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men of Caucasian ethnicity (not Mixed race or Jewish), aged 55 - 69 years, willing to undergo genetic SNP profiling.

Brief summary: 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.

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Association of SNP genetic risk score with prostate biopsy results.
timeFrame: 5 years
Secondary outcomes:
measure: Incidence and aggressiveness of PrCa in men within the top 10% of the genetic score.
timeFrame: 5 years
measure: Association of the biomarker profile with genetic score and biopsy results.
timeFrame: 5 years
measure: Use of genetic profiling to target prostate cancer screening in a clinical environment.
timeFrame: 5 years
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Institute of Cancer Research and Royal Marsden Hospital
state: Surrey
Study officials:
affiliation: Institute of Cancer Research and Royal Marsden Hospital
name: Rosalind A Eeles, FRCP, FRFR
role: PRINCIPAL_INVESTIGATOR
References: