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

NCT06259448 | Completed

• 1 other identifier: CHUBX 2022/63
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

cervical cancer; screening; urine self-sampling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cervical swab result

  Baseline

• Urine test result

  Baseline

Study Arms (1)

urine self-sampling

EXPERIMENTAL

urine self-sampling

Other: urine self-sampling

Interventions

urine self-sampling OTHER

urine self-sampling

urine self-sampling

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patient unable to speak French and/or illiterate
• Patient under legal protection

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 14, 2024
• Study Start: November 13, 2023
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)