The BARCODE 1 Study (Full Study): The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening. (BARCODE1)
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ClinicalTrials.gov Identifier: NCT03857477 |
Recruitment Status :
Recruiting
First Posted : February 28, 2019
Last Update Posted : March 31, 2022
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Condition or disease | Intervention/treatment |
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Prostate Cancer | Genetic: Genetic SNP profiling Other: Prostate cancer screening Procedure: MRI Scan Procedure: Prostate biopsy |
Study Type : | Observational |
Estimated Enrollment : | 4700 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | The BARCODE 1 Study: The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening. |
Actual Study Start Date : | March 14, 2019 |
Estimated Primary Completion Date : | September 1, 2022 |
Estimated Study Completion Date : | September 1, 2027 |

Group/Cohort | Intervention/treatment |
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Stage 1
Caucasian men aged 55-69 to undergo genetic SNP profiling.
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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 will be offered an MRI scan, prostate biopsy and prostate cancer screening.
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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: MRI Scan MRI scan will be offered to men identified within the top 10% genetic risk score profile.
Other Name: MRI Procedure: Prostate biopsy Transperineal prostate biopsy under local anaesthetic will be offered to men identified within the top 10% genetic risk score profile.
Other Name: Transperineal Biopsy (TP biopsy) |
- Association of SNP genetic risk score with prostate biopsy results. [ Time Frame: 5 years ]
- Incidence and aggressiveness of PrCa in men within the top 10% of the genetic score. [ Time Frame: 5 years ]
- Association of the biomarker profile with genetic score and biopsy results. [ Time Frame: 5 years ]
- Use of genetic profiling to target prostate cancer screening in a population screening clinical environment. [ Time Frame: 5 years ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 55 Years to 69 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Eligible participants must be of male gender at birth. |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.

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 ClinicalTrials.gov identifier (NCT number): NCT03857477
Contact: Eva McGrowder, PhD | + 44 208 722 4483 | eva.mcgrowder@icr.ac.uk | |
Contact: Elizabeth K Bancroft, PhD | +44 207 808 2136 |
United Kingdom | |
Institute of Cancer Research and Royal Marsden Hospital | Recruiting |
Sutton, Surrey, United Kingdom, SM2 5PT | |
Contact: Rosalind Eeles, FRCP FRFR 02086613642 rosalind.eeles@icr.ac.uk |
Principal Investigator: | Rosalind A Eeles, FRCP, FRFR | Institute of Cancer Research and Royal Marsden Hospital |
Responsible Party: | Institute of Cancer Research, United Kingdom |
ClinicalTrials.gov Identifier: | NCT03857477 |
Other Study ID Numbers: |
CCR5044 |
First Posted: | February 28, 2019 Key Record Dates |
Last Update Posted: | March 31, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Anonymised data can be applied for via the Data Access Committee. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Prostate Cancer |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |