Clinical trial · Observational
The BARCODE 1 Study (Full Study): The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening.
The BARCODE 1 Study: The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening.
NCT03857477CI-TRIAL-00089040BARCODE1active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genetic SNP profiling | Genetic | — | UNRESOLVED |
| MRI Scan | Procedure | — | UNRESOLVED |
| Prostate biopsy | Procedure | — | UNRESOLVED |
| Prostate cancer screening | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Stage 1
- description
- Caucasian men aged 55-69 to undergo genetic SNP profiling.
- interventionNames
- Genetic: Genetic SNP profiling
- label
- Stage 2
- description
- 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.
- interventionNames
- Genetic: Genetic SNP profiling
- Other: Prostate cancer screening
- Procedure: MRI Scan
- Procedure: Prostate biopsy
Primary outcomes (1)
- measure
- Association of SNP genetic risk score with prostate biopsy results.
- timeFrame
- 5 years
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 55 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (2)
- RESULTMcHugh 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 40214032
- DERIVEDHogben M, Hainsworth E, Benton B, McHugh J, Myhill K, McGrowder E, Rageevakumar R, James D, Benafif S, Page EC, Eeles RA, Rowland E, Bancroft EK. The psychosocial impact of receiving a polygenic risk score informing risk of prostate cancer. Hered Cancer Clin Pract. 2026 Jul 15. doi: 10.1186/s13053-026-00347-w. Online ahead of print. PMID 42458546