Clinical trial NCT06259448: Feasibility of Optimizing Organized Cervical Cancer Screening by Urine Self-sampling
Official title: Feasibility of Optimizing Organized Cervical Cancer Screening by Urine Self-sampling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: cervical cancer
screening
urine self-sampling
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 173
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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) : 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.

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

Primary outcomes:
measure: Urine self-sampling acceptability
timeFrame: Baseline
Secondary outcomes:
measure: Cervical swab result
timeFrame: Baseline
measure: Urine test result
timeFrame: Baseline
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References: