Feasibility of Optimizing Organized Cervical Cancer Screening by Urine Self-sampling (PAPPEES)

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer
• Intervention / Treatment: Other: urine self-sampling

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.

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • CHU Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: urine self-sampling	Other: urine self-sampling; urine self-sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine self-sampling acceptability	Acceptability rate of self-testing obtained via questionnaire: The questionnaire survey methodology enables both quantitative and qualitative qualitative analysis of practices, opinions and behaviors according to and behaviors according to respondent characteristics (age, gender, level of education...). level, etc.). Content analysis of responses to open-ended questions consists in creating categories and classifying the different discourses in these categories categories in order to identify the main themes. The level of satisfaction will be assessed by classifying the emerging categories according to positive perceptions and obstacles.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical swab result	positive/negative	Baseline
Urine test result	positive/negative	Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Actual): December 19, 2024
• Study Completion (Actual): December 19, 2024

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: screening; cervical cancer; urine self-sampling
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: CHUBX 2022/63; 2023-A00963-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No