The BARCODE 1 Study (Full Study): The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening.
NCT ID: NCT03857477
Last Updated: 2025-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
4700 participants
OBSERVATIONAL
2019-03-14
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Stage 1
Caucasian men aged 55-69 to undergo genetic SNP profiling.
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.
Genetic SNP profiling
Genetic SNP profiling of known prostate cancer predisposition SNPs will be performed on DNA extracted from saliva samples.
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.
MRI Scan
MRI scan will be offered to men identified within the top 10% genetic risk score profile.
Prostate biopsy
Transperineal prostate biopsy under local anaesthetic will be offered to men identified within the top 10% genetic risk score profile.
Interventions
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Genetic SNP profiling
Genetic SNP profiling of known prostate cancer predisposition SNPs will be performed on DNA extracted from saliva samples.
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.
MRI Scan
MRI scan will be offered to men identified within the top 10% genetic risk score profile.
Prostate biopsy
Transperineal prostate biopsy under local anaesthetic will be offered to men identified within the top 10% genetic risk score profile.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
55 Years
69 Years
MALE
Yes
Sponsors
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Institute of Cancer Research, United Kingdom
OTHER
Responsible Party
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Principal Investigators
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Rosalind A Eeles, FRCP, FRFR
Role: PRINCIPAL_INVESTIGATOR
Institute of Cancer Research and Royal Marsden Hospital
Locations
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Institute of Cancer Research and Royal Marsden Hospital
Sutton, Surrey, United Kingdom
Countries
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References
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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.
Related Links
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WHO Performance Status
Other Identifiers
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CCR5044
Identifier Type: -
Identifier Source: org_study_id
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