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The BARCODE 1 Pilot Study (BARCODE1Pilot)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03158922
Recruitment Status : Active, not recruiting
First Posted : May 18, 2017
Last Update Posted : March 3, 2021
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom

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.

Condition or disease Intervention/treatment
Prostate Cancer Genetic: Genetic SNP profiling Other: Prostate cancer screening Procedure: Prostate biopsy

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.

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Study Type : Observational
Actual Enrollment : 329 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The BARCODE 1 Pilot Study: The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening
Actual Study Start Date : April 29, 2016
Actual Primary Completion Date : April 14, 2018
Estimated Study Completion Date : April 29, 2021

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Stage 1
Caucasian men aged 55-69 to undergo genetic profiling.
Genetic: Genetic SNP profiling
Genetic SNP profiling of known prostate cancer predisposition SNPs will be performed on DNA extracted from saliva samples.

Stage 2
Men from Stage 1 identified as having a higher genetic risk score (top 10%) for prostate cancer.
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.
Other Name: TRUS Biopsy

Primary Outcome Measures :
  1. Association of SNP genetic risk score with prostate biopsy results. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Incidence and aggressiveness of PrCa in men within the top 10% of the genetic score. [ Time Frame: 5 years ]
  2. Association of the biomarker profile with genetic score and biopsy results. [ Time Frame: 5 years ]
  3. Use of genetic profiling to target prostate cancer screening in a clinical environment. [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Saliva, blood, urine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03158922

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United Kingdom
Institute of Cancer Research and Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
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Principal Investigator: Rosalind A Eeles, FRCP, FRFR Institute of Cancer Research and Royal Marsden Hospital
Additional Information:
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Responsible Party: Institute of Cancer Research, United Kingdom Identifier: NCT03158922    
Other Study ID Numbers: CCR4130
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised data can be applied for via the Data Access Committee.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases