Prostate CancerBARCODE1PilotNCT03158922
The BARCODE 1 Pilot Study
An observational study of Prostate Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 69 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Genetic SNP profiling, Prostate cancer screening and Prostate biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 329 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Apr 2016to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 69 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men of Caucasian ethnicity (not Mixed race or Jewish), aged 55 - 69 years, willing to undergo genetic SNP profiling.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Cancer Research and Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
About this study
Official title: The BARCODE 1 Pilot Study: The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Genetic SNP profiling, Prostate cancer screening, Prostate biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic SNP profilingGenetic
Genetic SNP profiling of known prostate cancer predisposition SNPs will be performed on DNA extracted from saliva samples.
Prostate cancer screeningOther
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.
Prostate biopsyProcedure or surgery
Also called TRUS Biopsy
Prostate biopsy will be offered to men identified within the top 10% genetic risk score profile.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 | Caucasian men aged 55-69 to undergo genetic profiling. Receives: Genetic: Genetic SNP profiling | |
| Stage 2 | Men from Stage 1 identified as having a higher genetic risk score (top 10%) for prostate cancer. Receives: Genetic: Genetic SNP profiling; Other: Prostate cancer screening; Procedure: Prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of SNP genetic risk score with prostate biopsy results.
Measured: 5 years
Secondary outcomes (3)
Incidence and aggressiveness of PrCa in men within the top 10% of the genetic score.
Measured: 5 years
Association of the biomarker profile with genetic score and biopsy results.
Measured: 5 years
Use of genetic profiling to target prostate cancer screening in a clinical environment.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start29 Apr 2016
- Primary completion14 Apr 2018
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosalind A Eeles, FRCP, FRFR, Principal investigator, Institute of Cancer Research and Royal Marsden Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158922
- Sponsor's protocol ID
- CCR4130
- Acronym
- BARCODE1Pilot
- Status last verified
- Oct 2026
- First submitted
- 17 May 2017
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data can be applied for via the Data Access Committee.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BARCODE 1 Pilot Study: The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening
- ClinicalTrials.gov ID
- NCT03158922
- Acronym / sponsor ID
- BARCODE1Pilot / CCR4130
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Study start
- 29 Apr 2016 (actual)
- Primary completion
- 14 Apr 2018 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1 | – | Genetic: Genetic SNP profilingCaucasian men aged 55-69 to undergo genetic profiling. |
| Stage 2 | – | Genetic: Genetic SNP profiling, Other: Prostate cancer screening, Procedure: Prostate biopsyMen from Stage 1 identified as having a higher genetic risk score (top 10%) for prostate cancer. |
Who may qualify
- Ages
- 55 to 69 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men of Caucasian ethnicity (not Mixed race or Jewish), aged 55 - 69 years, willing to undergo genetic SNP profiling.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic SNP profilingGenetic SNP profiling of known prostate cancer predisposition SNPs will be performed on DNA extracted from saliva samples. | Genetic | Stage 1, Stage 2 |
| Prostate cancer screeningProstate 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. | Other | Stage 2 |
| Prostate biopsyAlso: TRUS BiopsyProstate biopsy will be offered to men identified within the top 10% genetic risk score profile. | Procedure or surgery | Stage 2 |
Primary outcome
Association of SNP genetic risk score with prostate biopsy results.
Time frame: 5 years
3 secondary outcomes
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 clinical environment.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. Anonymised data can be applied for via the Data Access Committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosalind A Eeles, FRCP, FRFR principal investigator
Institute of Cancer Research and Royal Marsden Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of SNP genetic risk score with prostate biopsy results. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.