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BARCODE1Pilot: The BARCODE 1 Pilot Study

Sponsor
Institute of Cancer Research, United Kingdom (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03158922
Collaborator
(none)
329
Enrollment
1
Location
95.1
Anticipated Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Genetic SNP profiling
  • Other: Prostate cancer screening
  • 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 will be recruited via participating General Practices (GPs). 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 fill in a questionnaire to confirm eligibility to participate. This questionnaire can be completed in hard copy and men will also be given the option to fill in an online version. 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 30 men in total) will be invited for a transrectal ultrasound (TRUS) prostate biopsy, plus further biological samples. Biopsy results will be correlated with the genetic score. Prostate-specific antigen (PSA) and other biomarkers will be integrated into results to assess combined effects of genetic score and markers.

Study Design

Study Type:
Observational
Actual Enrollment :
329 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The BARCODE 1 Pilot Study: The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening
Actual Study Start Date :
Apr 29, 2016
Actual Primary Completion Date :
Apr 14, 2018
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Stage 1

Caucasian men aged 55-69 to undergo genetic 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.

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: Prostate biopsy
Prostate biopsy will be offered to men identified within the top 10% genetic risk score profile.
Other Names:
  • TRUS Biopsy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Association of SNP genetic risk score with prostate biopsy results. [5 years]

    Secondary Outcome Measures

    1. Incidence and aggressiveness of PrCa in men within the top 10% of the genetic score. [5 years]

    2. Association of the biomarker profile with genetic score and biopsy results. [5 years]

    3. Use of genetic profiling to target prostate cancer screening in a clinical environment. [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 69 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institute of Cancer Research and Royal Marsden Hospital Sutton Surrey United Kingdom SM2 5PT

    Sponsors and Collaborators

    • Institute of Cancer Research, United Kingdom

    Investigators

    • Principal Investigator: Rosalind A Eeles, FRCP, FRFR, Institute of Cancer Research and Royal Marsden Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Institute of Cancer Research, United Kingdom
    ClinicalTrials.gov Identifier:
    NCT03158922
    Other Study ID Numbers:
    • CCR4130
    First Posted:
    May 18, 2017
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Mar 31, 2022