Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06259448
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-01-23
Brief Title:
Feasibility of Optimizing Organized Cervical Cancer Screening by Urine Self-sampling
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Feasibility of Optimizing Organized Cervical Cancer Screening by Urine Self-sampling
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAPPEES
Brief Summary:
This project addresses the issue of promoting organized cervical cancer screening CCS from the perspective of the use of urine self-sampling USS Via a prospective and monocentric study the present study aims to evaluate the acceptability of women to collect a urine self-sample and to respond to a questionnaire on their feelings about this screening method
Detailed Description:
In France individual cervical cancer screening CCS has reduced the annual frequency of cervical cancer CC both in terms of incidence 2920 cases and mortality 1117 deaths 25 reduction in CC incidence was observed per year between 1980 and 2012 More than 6 millions CCS are performed each year leading to the diagnosis of approximately 170000 cytological abnormalities including about 15000 high-grade intraepithelial lesions precursors of cancer Since 2019 CCS is now recommended in France with cytology-based screening before 30 and high risk Human Papillomavirus HPV testing from 30 to 65 years-old screening interval of 5 years after a negative test
Since only 50 to 60 of the target population is currently screened the French High Authority for Health HAS has recently recommended the implementation of an organized screening program OSP to increase screening-participation and to reduce inequalities in access to screening This OSP includes sending an invitation to under screened women for a consultation and a clinician taken cervical sample However the response rate to the OSP of cancers to a first letter of invitation is generally low less than 20 for example the rate of participation in colon cancer screening in the french department of Gironde is 188 in 2020 data from French Regional Coordination Center for Cancer Screening This trend is particularly true in rural areas with low medical density northern and southern areas of Gironde are concerned with 23 of under-screened women for CCS Reducing social and territorial inequalities in participation in organized CCS and optimizing the screening process for the least participating women remain a challenge
Self-sampling kits with the possibility to be sent to the women seem to be a promising alternative to overcome the low participation in these areas
Vaginal self-sampling has already been shown to increase participation More recent studies have focused on urine self-sampling for the detection of cervical precancer
Since only 50 to 60 of the target population is currently screened the French High Authority for Health HAS has recently recommended the implementation of an organized screening program OSP to increase screening-participation and to reduce inequalities in access to screening This OSP includes sending an invitation to under screened women for a consultation and a clinician taken cervical sample However the response rate to the OSP of cancers to a first letter of invitation is generally low less than 20 for example the rate of participation in colon cancer screening in the french department of Gironde is 188 in 2020 data from French Regional Coordination Center for Cancer Screening This trend is particularly true in rural areas with low medical density northern and southern areas of Gironde are concerned with 23 of under-screened women for CCS Reducing social and territorial inequalities in participation in organized CCS and optimizing the screening process for the least participating women remain a challenge
Self-sampling kits with the possibility to be sent to the women seem to be a promising alternative to overcome the low participation in these areas
Vaginal self-sampling has already been shown to increase participation More recent studies have focused on urine self-sampling for the detection of cervical precancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None