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Trial Title:
Feasibility of Optimizing Organized Cervical Cancer Screening by Urine Self-sampling
NCT ID:
NCT06259448
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
cervical cancer
screening
urine self-sampling
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
urine self-sampling
Description:
urine self-sampling
Arm group label:
urine self-sampling
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)
: 2.5% 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 170,000
cytological abnormalities, including about 15,000 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 18.8% 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 2/3 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Women aged 31 to 49
- Coming to the Bordeaux University Hospital for a gynecological consultation in order
to have a cervical swab (PCC) for screening or follow-up.
- Patient affiliated to or benefiting from a social security system
- Non-objection to study participation
Exclusion Criteria:
- Patient unable to speak French and/or illiterate
- Patient under legal protection
Gender:
Female
Minimum age:
18 Years
Maximum age:
49 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU Bordeaux
Address:
City:
Bordeaux
Country:
France
Status:
Recruiting
Contact:
Last name:
Jean-Luc Brun, MD, PhD
Phone:
+33 556 79 56 79
Email:
jean-luc.brun@chu-bordeaux.fr
Start date:
November 13, 2023
Completion date:
November 2024
Lead sponsor:
Agency:
University Hospital, Bordeaux
Agency class:
Other
Source:
University Hospital, Bordeaux
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06259448
