Clinical trial · Observational
The BARCODE 1 Pilot Study
The BARCODE 1 Pilot Study: The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening
NCT03158922CI-TRIAL-00095857BARCODE1Pilotactive 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. This study forms a pilot of 300 men, with the view to continue to a future study 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genetic SNP profiling | Genetic | — | 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 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.
- interventionNames
- Genetic: Genetic SNP profiling
- Other: Prostate cancer screening
- 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 55-69 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)
References
Publications (0)
Data not yet available
No reference posted for this study.