The BARCODE 1 Study (Full Study): The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening.
BARCODE1
The BARCODE 1 Study: The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening.
1 other identifier
observational
4,700
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2019
CompletedFirst Posted
Study publicly available on registry
February 28, 2019
CompletedStudy Start
First participant enrolled
March 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
ExpectedApril 29, 2025
April 1, 2025
5.1 years
February 26, 2019
April 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Association of SNP genetic risk score with prostate biopsy results.
5 years
Secondary Outcomes (3)
Incidence and aggressiveness of PrCa in men within the top 10% of the genetic score.
5 years
Association of the biomarker profile with genetic score and biopsy results.
5 years
Use of genetic profiling to target prostate cancer screening in a population screening clinical environment.
5 years
Study Arms (2)
Stage 1
Caucasian men aged 55-69 to undergo genetic SNP profiling.
Stage 2
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.
Interventions
Genetic SNP profiling of known prostate cancer predisposition SNPs will be performed on DNA extracted from saliva samples.
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.
MRI scan will be offered to men identified within the top 10% genetic risk score profile.
Transperineal prostate biopsy under local anaesthetic will be offered to men identified within the top 10% genetic risk score profile.
Eligibility Criteria
Men of Caucasian ethnicity (not Mixed race or Jewish), aged 55 - 69 years, willing to undergo genetic SNP profiling.
You may qualify if:
- Men aged 55 to 69 years.
- Caucasian ethnicity.
- 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.
You may not qualify if:
- Non-Caucasian ethnicity (including mixed race or Ashkenazi Jewish (excluded as these groups have different genetic risk profiles from those being studied).
- Previous diagnosis of cancer with a life-expectancy of less than five years.
- Negative prostate biopsy within one year before recruitment.
- Previous diagnosis of prostate cancer.
- Co-morbidities making prostate biopsy risk unacceptable (anticoagulants or antiplatelet medication including Warfarin, Clopidogrel, Apixaban, Dabigatran or other NOAC medications (Novel Oral Anti-Coagulant); poorly controlled diabetes, cardiovascular/respiratory disease, immunosuppressive medication or splenectomy).
- Men with body mass index (BMI) 40 and above.
- Men with BMI 35 and above plus other co-morbidities.
- Contraindications to having an MRI (pacemakers, aneurysm clips, metallic cardiac valve/stent, Ventriculo-Peritoneal (VP) shunt, cochlear implant, neurotransmitter, metallic foreign bodies in eye(s), other metalwork, claustrophobia).
- Any significant psychological conditions that may be worsened or exacerbated by participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Cancer Research and Royal Marsden Hospital
Sutton, Surrey, SM2 5PT, United Kingdom
Related Publications (1)
McHugh JK, Bancroft EK, Saunders E, Brook MN, McGrowder E, Wakerell S, James D, Rageevakumar R, Benton B, Taylor N, Myhill K, Hogben M, Kinsella N, Sohaib AA, Cahill D, Hazell S, Withey SJ, Mcaddy N, Page EC, Osborne A, Benafif S, Jones AB, Patel D, Huang DY, Kaur K, Russell B, Nicholson R, Croft F, Sobczak J, McNally C, Mutch F, Bennett S, Kingston L, Karlsson Q, Dadaev T, Saya S, Merson S, Wood A, Dennis N, Hussain N, Thwaites A, Hussain S, Rafi I, Ferris M, Kumar P, James ND, Pashayan N, Kote-Jarai Z, Eeles RA; BARCODE1 Steering Committee and Collaborators. Assessment of a Polygenic Risk Score in Screening for Prostate Cancer. N Engl J Med. 2025 Apr 10;392(14):1406-1417. doi: 10.1056/NEJMoa2407934.
PMID: 40214032BACKGROUND
Related Links
Biospecimen
Saliva, blood, urine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rosalind A Eeles, FRCP, FRFR
Institute of Cancer Research and Royal Marsden Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2019
First Posted
February 28, 2019
Study Start
March 14, 2019
Primary Completion
April 1, 2024
Study Completion (Estimated)
December 31, 2028
Last Updated
April 29, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
Anonymised data can be applied for via the Data Access Committee.