Status:
ACTIVE_NOT_RECRUITING
The BARCODE 1 Study (Full Study): The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening.
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Conditions:
Prostate Cancer
Eligibility:
MALE
55-69 years
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 feasibil...
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 me...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 14 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2028
Estimated Enrollment :
4700 Patients enrolled
Trial Details
Trial ID
NCT03857477
Start Date
March 14 2019
End Date
December 31 2028
Last Update
April 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute of Cancer Research and Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT