Cancer Screening TestCapU4NCT05243888
Efficacy of Strategies Involving Self-sampling to Reach Women Not Participating in Regular Cervical Cancer Screening
A study testing self-sampling in people with Cancer Screening Test, run by Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer Screening Test
- What is being tested?
- self-sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,000 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2022to Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- recent cervical sampling (less than three years old)
- women younger than 30 or older than 65 years
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial Assessing the Efficacy of Strategies Involving Self-sampling to Reach Women Not Participating in Regular Cervical Cancer Screening
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.
Read more
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.
Read the detailed description
Research question: does the offer of self-sampling kits result in higher attendance to cervical cancer screening compared to sending invitation letters which recommend women to contact a health professional for taking a cervical specimen?
Systematic reviews indicate that Human Papillomavirus (HPV) testing on vaginal specimens taken by the woman her-self is as accurate to detect cervical precancer as HPV testing of cervical specimens collected by a clinician, under the condition that a validated polymerase chain reaction (PCR)-based HPV assay is used. Similar results are shown from recent studies where HPV testing was performed on first-void urine collected with an appropriate device and transport medium. A recent meta-analysis of randomised trials showed higher response rates when under-screened women receive a self-sampling kit at home compared to traditional invitation or reminder letters. However, the absolute participation rates are highly variable among studies. Whereas qualitative research indicates that women prefer collection of urine rather than a vaginal self-sample, no data are available that the offer of urine kits would result in higher participation among women who do not participate regularly in cervical cancer screening.
Objectives:
- To evaluate the effectiveness of two experimental invitation strategies (urine or vaginal self-sampling) to reach under-screened populations and compare them to the current invitation strategy in rural departments in France.
- To improve the response rate among women aged 30 to 65 years (not screened over a period longer than the recommended screening interval) who did not respond to a conventional prior invitation.
Trial design:
1:1:1 randomised population-based participation trial, with 2 experimental and 1 control arm, with in each arm a 1:1 sub-randomisation with subgroup A receiving a questionnaire and subgroup B receiving no questionnaire.
- Conditions
- Cancer Screening Test
- Being tested
- self-sampling
- Keywords
- cervical cancer, screening coverage, cancer screening test, under-screened women, urinary self-sampling, vaginal self-sampling, randomised controlled trial, semi-structured interviews
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-samplingDiagnostic test
eligible women receive at their home address a self-sampling kit in addition to the conventional invitation letter
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | The control arm corresponds to women receive a conventional invitation letter sent by post to the home address of eligible women recommending them to make an appointment to a doctor or a midwife for the collection of a cervical specimen. |
| vaginal self-sampling | Experimental | eligible women receive at their home address a vaginal self-sampling kit in addition to the conventional invitation letter Receives: Diagnostic Test: self-sampling |
| urinary self-sampling | Experimental | eligible women receive at their home address a urine collection kit in addition to the conventional invitation letter Receives: Diagnostic Test: self-sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of participation in each arm (%)
(number of responding / number of invited)
Measured: 6 months
Secondary outcomes (14)
Rate of participation (%)
(number of responding / number of invited). Contrast in participation between the 2 experimental arms
Measured: 6 months
Rate of participation (%) with questionnaire or not
(number of responding / number of invited). Contrast in participation between women that received a questionnaire or not
Measured: 6 months
Rate of screen test positivity (%)
Virological result. presence of high-risk HPV
Measured: 24 months
Percentage of women screened positive with adherence to gynecological follow-up
gynecological follow-up (cytological results)
Measured: 24 months
Impact of age on the participation (rate of participation %)
age
Measured: 6 months
Impact of age on the adherence to gynecological follow-up (% of women)
age
Measured: 24 months
Impact of reimbursement status on the participation (rate of participation %)
reimbursement status (benefit or not from supplementary universal health care coverage)
Measured: 6 months
Impact of reimbursement status on the adherence to gynecological follow-up (% of women)
reimbursement status (benefit or not from supplementary universal health care coverage)
Measured: 24 months
Impact of geographical area on the participation (rate of participation %)
geographical area (including the deprivation index corresponding with the statistical sector where the woman is domiciled)
Measured: 6 months
Impact of geographical area on the adherence to gynecological follow-up (% of women)
geographical area (geographical area (including the deprivation index corresponding with the statistical sector where the woman is domiciled)
Measured: 24 months
Obstacles and levers emerging from the speech of the women participating in the research (thematic analysis)
thematic analysis integrating a specific focus on the indicators identified in previous studies (e.g. lack of time, discomfort with regard to the location or bad experience encountered during another type of examination, etc.).
Measured: 24 months
Obstacles and levers emerging from the speech of the women participating in the research (categorical analysis)
categorical analysis based on Linguistic Inquiry and Word count which allows, among other things, to automatically categorise positive or negative emotions related to themes for example associated with the disease or beliefs
Measured: 24 months
Obstacles and levers emerging from the speech of the health professionals participating in the research (thematic analysis)
thematic analysis integrating a specific focus on the indicators identified in previous studies (e.g. lack of time, discomfort with regard to the location or bad experience encountered during another type of examination, etc.).
Measured: 24 months
Obstacles and levers emerging from the speech of the health professionals participating in the research (categorical analysis)
categorical analysis based on Linguistic Inquiry and Word count which allows, among other things, to automatically categorise positive or negative emotions related to themes for example associated with the disease or beliefs
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start9 Mar 2022
- Primary completion31 Aug 2023
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Screening TestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, Sciensano, University Hospital, Angers, Angers University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243888
- Sponsor's protocol ID
- 2021-A01660-41
- Acronym
- CapU4
- Status last verified
- Feb 2025
- First submitted
- 26 Jan 2022
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Assessing the Efficacy of Strategies Involving Self-sampling to Reach Women Not Participating in Regular Cervical Cancer Screening
- ClinicalTrials.gov ID
- NCT05243888
- Acronym / sponsor ID
- CapU4 / 2021-A01660-41
- Conditions
- Cancer Screening Test
- Keywords
- cervical cancer, screening coverage, cancer screening test, under-screened women, urinary self-sampling, vaginal self-sampling, randomised controlled trial, semi-structured interviews
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Centre Regional de Coordination des Depistages des Cancer - Pays de la LoireUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, Sciensano, University Hospital, Angers, Angers University
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- Mar 2025 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research question: does the offer of self-sampling kits result in higher attendance to cervical cancer screening compared to sending invitation letters which recommend women to contact a health professional for taking a cervical specimen?
Systematic reviews indicate that Human Papillomavirus (HPV) testing on vaginal specimens taken by the woman her-self is as accurate to detect cervical precancer as HPV testing of cervical specimens collected by a clinician, under the condition that a validated polymerase chain reaction (PCR)-based HPV assay is used. Similar results are shown from recent studies where HPV testing was performed on first-void urine collected with an appropriate device and transport medium. A recent meta-analysis of randomised trials showed higher response rates when under-screened women receive a self-sampling kit at home compared to traditional invitation or reminder letters. However, the absolute participation rates are highly variable among studies. Whereas qualitative research indicates that women prefer collection of urine rather than a vaginal self-sample, no data are available that the offer of urine kits would result in higher participation among women who do not participate regularly in cervical cancer screening.
Objectives:
- To evaluate the effectiveness of two experimental invitation strategies (urine or vaginal self-sampling) to reach under-screened populations and compare them to the current invitation strategy in rural departments in France.
- To improve the response rate among women aged 30 to 65 years (not screened over a period longer than the recommended screening interval) who did not respond to a conventional prior invitation.
Trial design:
1:1:1 randomised population-based participation trial, with 2 experimental and 1 control arm, with in each arm a 1:1 sub-randomisation with subgroup A receiving a questionnaire and subgroup B receiving no questionnaire.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –The control arm corresponds to women receive a conventional invitation letter sent by post to the home address of eligible women recommending them to make an appointment to a doctor or a midwife for the collection of a cervical specimen. |
| vaginal self-sampling | Experimental | Diagnostic Test: self-samplingeligible women receive at their home address a vaginal self-sampling kit in addition to the conventional invitation letter |
| urinary self-sampling | Experimental | Diagnostic Test: self-samplingeligible women receive at their home address a urine collection kit in addition to the conventional invitation letter |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- recent cervical sampling (less than three years old)
- women younger than 30 or older than 65 years
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-samplingeligible women receive at their home address a self-sampling kit in addition to the conventional invitation letter | Diagnostic test | urinary self-sampling, vaginal self-sampling |
Primary outcome
Rate of participation in each arm (%)
Time frame: 6 months
(number of responding / number of invited)
14 secondary outcomes
Rate of participation (%)
Time frame: 6 months
Rate of participation (%) with questionnaire or not
Time frame: 6 months
Rate of screen test positivity (%)
Time frame: 24 months
Percentage of women screened positive with adherence to gynecological follow-up
Time frame: 24 months
Impact of age on the participation (rate of participation %)
Time frame: 6 months
Impact of age on the adherence to gynecological follow-up (% of women)
Time frame: 24 months
Impact of reimbursement status on the participation (rate of participation %)
Time frame: 6 months
Impact of reimbursement status on the adherence to gynecological follow-up (% of women)
Time frame: 24 months
Impact of geographical area on the participation (rate of participation %)
Time frame: 6 months
Impact of geographical area on the adherence to gynecological follow-up (% of women)
Time frame: 24 months
Obstacles and levers emerging from the speech of the women participating in the research (thematic analysis)
Time frame: 24 months
Obstacles and levers emerging from the speech of the women participating in the research (categorical analysis)
Time frame: 24 months
Obstacles and levers emerging from the speech of the health professionals participating in the research (thematic analysis)
Time frame: 24 months
Obstacles and levers emerging from the speech of the health professionals participating in the research (categorical analysis)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-sampling in people with Cancer Screening Test, run by Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of participation in each arm (%) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.