NCT05243888Active, not recruiting
Efficacy of Strategies Involving Self-sampling to Reach Women Not Participating in Regular Cervical Cancer Screening
A Randomised Controlled Trial Assessing the Efficacy of Strategies Involving Self-sampling to Reach Women Not Participating in Regular Cervical Cancer Screening
Source: ClinicalTrials.gov · Last updated 5 Feb 2025
Brief summary (registry, in English)
The cervical cancer screening coverage remains moderate (60%) in France. The aim of the study is to evaluate the efficacy of two experimental invitation strategies (offer of urine or vaginal self-sampling kits) to reach under-screened populations and compare them with the current invitation strategy in rural departments (low medical density and low participation rate) in France. The study is a randomised controlled trial with three arms: a control arm (conventional invitation letter) and two experimental arms (mailing of a urine or vaginal self-sampling kit). The target population includes women aged 30-65 years, who had no screening test recorded since more than four years and who did not respond to an invitation letter within twelve months before. The primary outcome measure is the participation rate in each arm. A team of psychologists will also investigate attitudes and experiences by semi-structured/focus-group interviews with voluntary CapU4 participants and with health professionals. CapU4 will identify effective strategies to reach women not responding to current screening invitations and will generate information about acceptance of self-sampling among women and health professionals.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 15000 (estimated)
- First submitted
- 26 Jan 2022
- Start date
- 9 Mar 2022
- Primary completion date
- 31 Aug 2023
- Lead sponsor
- Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire
- Diseases
- Cervical cancer
- NCT number
- NCT05243888
What you commit to
- Study type: Interventional
- Planned participants: 15000
- From 9 Mar 2022 to the primary completion date, 31 Aug 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- recent cervical sampling (less than three years old)
- women younger than 30 or older than 65 years
Other
- women who have had a hysterectomy
- women with ongoing follow-up for a cervical lesion
- women who are not members or beneficiaries of a social security system.
Who the study is looking for
- women aged between 30 and 65 years
- living in the Departments of Mayenne, Vendée and Sarthe (Pays de la Loire, France)
- who have not carried out a screening test (cytology of smear or HPV test) following a letter sent 12 months previously (in 2020 or 2021).
Age in the registry: 30 years to 65 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CRCDC Pays de la Loire Coordinator of this site? Confirm its status | Angers | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.