Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636526
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
The I4i PRODICT Study Evaluation of the I4i PRODICT Test in Different Ethnic Groups The I4i PRODICT Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The I4i PRODICT Study Evaluation of the I4i PRODICT Test in Different Ethnic Groups
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The i4i PRODICT study has been developed to investigate the uptake and acceptability of the i4i PRODICT test which combines both common and rare genetic changes genetic variants into one saliva-based DNA test to estimate a persons future risk of prostate cancer PrCa in people of varying ethnicities
Detailed Description:
The i4i PRODICT study aims to recruit 1000 people with a prostate PwP aged 40-55 years old divided into three ethnic backgrounds i Black African and Black African-Caribbean ii South Asian or East Asian or iii White European ancestry These ethnic backgrounds are defined as having all 4 grandparents of the same ancestry People with a prostate is defined as people born with male reproductive organs We believe this will provide us with data that are reproducible and implementable within the UK population as well as enrich recruitment from underserved non-White European communities in order to evaluate this approach within a future potential national screening programme
Recruitment will take place via collaborating General Practice GP surgeries Participants will be contacted via a letter from their GP and if interested in the study they will be asked to complete an eligibility questionnaire and sign a consent form Eligible participants will be sent a DNA collection saliva kit DNA will be extracted from saliva and analysed using the i4i PRODICT test Those participants identified at higher genetic risk corresponding to the top 20 of the White European cohort top 50 of the Black African African-Caribbean cohort and top 10 of the Asian cohort approximately 250 individuals in total or those identified as having a rare variant estimated to be 1 in 20 people - ie 50 individuals will be invited for PrCa screening annually for 3 years PrCa screening will mirror the primary care pathway those in the high-risk group will be offered a PSA test and managed according to age-appropriate PSA thresholds Where indicated onward referral for prostate MRI and prostate biopsy will follow as per the NICE guidelines For participants receiving a diagnosis of PrCa they will be offered treatment at The Royal Marsden Hospital or onward referral to their local cancer centre if preferred by the patient
Recruitment will take place via collaborating General Practice GP surgeries Participants will be contacted via a letter from their GP and if interested in the study they will be asked to complete an eligibility questionnaire and sign a consent form Eligible participants will be sent a DNA collection saliva kit DNA will be extracted from saliva and analysed using the i4i PRODICT test Those participants identified at higher genetic risk corresponding to the top 20 of the White European cohort top 50 of the Black African African-Caribbean cohort and top 10 of the Asian cohort approximately 250 individuals in total or those identified as having a rare variant estimated to be 1 in 20 people - ie 50 individuals will be invited for PrCa screening annually for 3 years PrCa screening will mirror the primary care pathway those in the high-risk group will be offered a PSA test and managed according to age-appropriate PSA thresholds Where indicated onward referral for prostate MRI and prostate biopsy will follow as per the NICE guidelines For participants receiving a diagnosis of PrCa they will be offered treatment at The Royal Marsden Hospital or onward referral to their local cancer centre if preferred by the patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None