The BARCODE 1 Pilot Study

Prostate Cancer Clinical Trial

— BARCODE1Pilot  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03158922
• Other study ID #: CCR4130
• Status: Active, not recruiting
• Start date: April 29, 2016
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2023
• Source: Institute of Cancer Research, United Kingdom
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 329
• Est. completion date: April 1, 2024
• Est. primary completion date: April 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 55 Years to 69 Years

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Other:
• Prostate cancer screening
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.

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

Locations

Country	Name	City	State
United Kingdom	Institute of Cancer Research and Royal Marsden Hospital	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of SNP genetic risk score with prostate biopsy results.		5 years
Secondary	Incidence and aggressiveness of PrCa in men within the top 10% of the genetic score.		5 years
Secondary	Association of the biomarker profile with genetic score and biopsy results.		5 years
Secondary	Use of genetic profiling to target prostate cancer screening in a clinical environment.		5 years

External Links

•   WHO Performance Status document