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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 : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom

Study Description
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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.

Condition or disease Intervention/treatment
Prostate Cancer Genetic: Genetic SNP profiling Other: Prostate cancer screening Procedure: MRI Scan Procedure: Prostate biopsy

Detailed Description:
The BARCODE 1 study aims to evaluate genetic profiling using the known ~170 prostate cancer (PrCa) risk single-nucleotide polymorphisms (SNPs) as a means of offering targeted screening for PrCa in men at a genetically higher risk. Initially, 300 men were recruited via participating General Practices (GPs). The full study aims to recruit an additional 4700 participants. Men aged 55-69 years who are likely to be eligible for the study will be identified by GPs from medical records. Participants will be contacted via invitation letters from GPs and if interested in the study will be asked to sign a consent form and complete a questionnaire to confirm eligibility to participate. If eligible, men will then be sent a DNA collection saliva kit. DNA from saliva will be analysed with SNP profiling for the known ~170 clinically relevant SNPs. Men with a genetic risk equivalent to the top 10% of the population distribution (approximately 470 men in total from the full study) will be invited for an MRI and a transrectal ultrasound (TRUS) prostate biopsy, plus further biological samples. Biopsy results will be correlated with the genetic score. The study also aims to determine the incidence and aggressiveness of prostate cancer in men within the top 10% of the genetic score. Furthermore, the association of MRI appearance and biological sample biomarker profile with prostate biopsy result in men at genetically higher prostate cancer risk undergoing targeted screening will also be determined.
Study Design
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Stage 1
Caucasian men aged 55-69 to undergo genetic SNP profiling.
 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.
 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
Prostate biopsy will be offered to men identified within the top 10% genetic risk score profile.
Other Name: TRUS Biopsy


Outcome Measures
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Primary Outcome Measures :
  1. Association of SNP genetic risk score with prostate biopsy results. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Incidence and aggressiveness of PrCa in men within the top 10% of the genetic score. [ Time Frame: 5 years ]
  2. Association of the biomarker profile with genetic score and biopsy results. [ Time Frame: 5 years ]
  3. Use of genetic profiling to target prostate cancer screening in a clinical environment. [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Saliva, blood, urine

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Sampling Method:   Non-Probability Sample
Study Population
Men of Caucasian ethnicity (not Mixed race or Jewish), aged 55 - 69 years, willing to undergo genetic SNP profiling.
Criteria

Inclusion Criteria:

  • Men aged 55 to 69 years.
  • Caucasian ethnicity.
  • WHO performance status 0-2 (see Appendix A).
  • 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 or cardiovascular disease).
  • 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, claustrophobia).
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Eva McGrowder, PhD + 44 208 722 4483 eva.mcgrowder@icr.ac.uk
Contact: Elizabeth K Bancroft, PhD +44 207 808 2136

Locations
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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   
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Investigators
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Principal Investigator: Rosalind A Eeles, FRCP, FRFR Institute of Cancer Research and Royal Marsden Hospital
More Information
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Additional Information:

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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: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised data can be applied for via the Data Access Committee.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institute of Cancer Research, United Kingdom:
Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases