Cervical CancerMIRABELLENCT06749847
HPV Self-sampling in the General Population
A study testing Women receive invitation letter with HPV self-sampling kit and Women receive invitation letter with choice of ordering a free self-sampling kit or visit healthcare provider in people with Cervical Cancer, run by International Agency for Research on Cancer at 2 sites in France.
Trial summary
A randomized controlled trial comparing three strategies for cervical cancer screening: direct mailing of HPV self-sampling kit ("Outreach" arm), choice between self-sampling or healthcare provider sampling ("Choice" arm), and standard care (control arm) in two French departments. 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
- Cervical Cancer
- What is being tested?
- Women receive invitation letter with HPV self-sampling kit and Women receive invitation letter with choice of ordering a free self-sampling kit or visit healthcare provider
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Jun 2025to 31 Dec 2026
- 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 30 to 65 years old
- Living in the study area (Departments of Marne and Aube, France)
- At moderate risk of cervical cancer, i.e. eligible to the organised programme and receiving the first invitation of the screening round (not a reminder letter)
Who cannot join
- Outside the target age (less than 30 years old, or 66 years old and more)
- Already participating in the current screening round
- Total hysterectomy
- History of cervical cancer
- Current follow-up for abnormal cervical screening result or cervical lesions
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Regional Cancer Screening Coordinating Centre, Marne site
Reims, Marne, 51100
Aurélie BERTRAND-BRICE, MD, 03-25-41-62-87, a.bertrand@depistagecancer-ge.fr
- Recruiting
Regional Cancer Screening Coordinating Centre, Aube site
Troyes, Aube, 10000
Lucie FIEVET, MD, 03-26-84-93-31, l.fievet@depistagecancer-ge.fr
About this study
Official title: HPV Self-sampling in the General Population: Efficacy, Feasibility, Acceptability and Cost-effectiveness
A randomized controlled trial comparing three strategies for cervical cancer screening: direct mailing of HPV self-sampling kit ("Outreach" arm), choice between self-sampling or healthcare provider sampling ("Choice" arm), and standard care (control arm) in two French departments.
Read the detailed description
In France, over 3,000 women are diagnosed annually with cervical cancer and 1,100 die from it, despite organized screening programs. The national screening coverage rate of 59% (2018- 2020) remains well below the European Union's recommended target of 70% and even further from the French Cancer Plan 2014-2019 objective of 80%. This study evaluates two innovative strategies to improve participation rates in two French departments (Marne and Aube). Eligible women aged 30-65 years will be randomized into three arms. The "Outreach" arm receives HPV self-sampling kit directly at home with SMS reminder at 3 months if no participation. The "Choice" arm can choose between ordering a self-sampling kit or visiting a healthcare provider with SMS reminder at 3 months if no participation. The control arm follows standard procedure with self-sampling offered at 12-month reminder. Women with positive HPV self-sampling tests will be followed for triage cytology, with assistance provided for appointments in the "Outreach" arm and reminders at 6 months post-positive result in the "Choice" arm. The study assesses participation rates, triage completion rates, feasibility, acceptability, and cost-effectiveness of these strategies. If successful, findings could inform modifications to the national organized screening program.
- Conditions
- Cervical Cancer
- Being tested
- Women receive invitation letter with HPV self-sampling kit, Women receive invitation letter with choice of ordering a free self-sampling kit or visit healthcare provider
- Keywords
- Cervical cancer, screening program, pilot project, randomised control trial, France
- 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.
Women receive invitation letter with HPV self-sampling kitOther
Direct mailing of HPV self-sampling kit. Women receive HPV self-sampling kit with instructions. SMS reminder at 3 months if no participation. Assistance provided for triage cytology if HPV positive.
Women receive invitation letter with choice of ordering a free self-sampling kit or visit healthcare providerOther
Option between self-sampling and healthcare provider: women can choose testing method. If self-sampling chosen, kit sent to home. SMS reminder at 3 months if no participation.
| Study group | Role | What they receive |
|---|---|---|
| Outreach | Experimental | Women receive invitation letter with HPV self-sampling kit; Direct mailing of HPV self-sampling kit; Women receive HPV self-sampling kit with instructions; SMS reminder at 3 months if no participation; Assistance provided for triage cytology if HPV positive. Receives: Other: Women receive invitation letter with HPV self-sampling kit |
| Choice | Experimental | Women receive an invitation letter offering a choice between ordering a free self-sampling kit or visiting a healthcare provider.
Option between self-sampling and healthcare provider: women can choose testing method. If self-sampling chosen, kit sent to home. SMS reminder at 3 months if no participation. Receives: Other: Women receive invitation letter with choice of ordering a free self-sampling kit or visit healthcare provider |
| Control arm | No intervention | Standard invitation to visit healthcare provider for cervical cancer screening. Standard screening procedure. Follow standard organized screening program procedure. HPV self-sampling offered at 12-month reminder if no participation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate in cervical cancer screening
Measured: 18 months after invitation
Secondary outcomes (6)
Triage cytology completion rate after positive HPV test
Measured: 6 months after positive result
HPV positivity rate
Measured: 12 months after invitation
Invalid result rate
Measured: 18 months
Time from HPV-positive result to completion of cytological triage
Measured: 18 months
Women's acceptability of HPV self-sampling
Qualitative assessment through semi-structured interviews with 40 women to assess women's acceptability of HPV self-sampling
Measured: 24 months
Cost-effectiveness of screening strategies
Costs will be estimated using an ingredients approach whereby resources used for the respective interventions (' Outreach ' and ' Choice' strategies) are identified and valued. The analysis will include all costs incurred by the screening program, including invitation materials, self-sampling kits, laboratory testing, result communication, and follow-up coordination. The incremental cost-effectiveness ratios (ICERs) will be calculated as the mean difference in total costs between each intervention arm and the control arm, divided by the mean difference in screening participation rates. Results will be expressed in euros per percentage change in screening participation.
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 posted27 Dec 2024
- Study start26 Jun 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies 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
- This is a three-arm study
- Masking
- None (open label)
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, Central Hospital, Nancy, France, CHU de Reims
- Responsible party
- Sponsor
- Investigators
- Aurélie BERTRAND-BRICE, MD, Principal investigator, Regional Cancer Screening Coordinating Centre, Marne siteChristine CLAVEL CRAVOISIER, Professor, Principal investigator, CHU de ReimsHamza ACHIT, PhD, Principal investigator, CHRU NancyFarida SELMOUNI, PhD, Principal investigator, International Agency for Research on CancerCatherine SAUVAGET, MD, PhD, Principal investigator, International Agency for Research on Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749847
- Sponsor's protocol ID
- IEC/24-01
- Other IDs
- 2023-215
- Acronym
- MIRABELLE
- Status last verified
- Jul 2025
- First submitted
- 13 Dec 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Self-sampling in the General Population: Efficacy, Feasibility, Acceptability and Cost-effectiveness
- ClinicalTrials.gov ID
- NCT06749847
- Acronym / sponsor ID
- MIRABELLE / IEC/24-01
- Conditions
- Cervical Cancer
- Keywords
- Cervical cancer, screening program, pilot project, randomised control trial, France
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- International Agency for Research on CancerUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, Central Hospital, Nancy, France, CHU de Reims
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Dec 2024 (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.
A randomized controlled trial comparing three strategies for cervical cancer screening: direct mailing of HPV self-sampling kit ("Outreach" arm), choice between self-sampling or healthcare provider sampling ("Choice" arm), and standard care (control arm) in two French departments.
Detailed description
In France, over 3,000 women are diagnosed annually with cervical cancer and 1,100 die from it, despite organized screening programs. The national screening coverage rate of 59% (2018- 2020) remains well below the European Union's recommended target of 70% and even further from the French Cancer Plan 2014-2019 objective of 80%. This study evaluates two innovative strategies to improve participation rates in two French departments (Marne and Aube). Eligible women aged 30-65 years will be randomized into three arms. The "Outreach" arm receives HPV self-sampling kit directly at home with SMS reminder at 3 months if no participation. The "Choice" arm can choose between ordering a self-sampling kit or visiting a healthcare provider with SMS reminder at 3 months if no participation. The control arm follows standard procedure with self-sampling offered at 12-month reminder. Women with positive HPV self-sampling tests will be followed for triage cytology, with assistance provided for appointments in the "Outreach" arm and reminders at 6 months post-positive result in the "Choice" arm. The study assesses participation rates, triage completion rates, feasibility, acceptability, and cost-effectiveness of these strategies. If successful, findings could inform modifications to the national organized screening program.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a three-arm study
| Arm | Type | Receives |
|---|---|---|
| Outreach | Experimental | Other: Women receive invitation letter with HPV self-sampling kitWomen receive invitation letter with HPV self-sampling kit; Direct mailing of HPV self-sampling kit; Women receive HPV self-sampling kit with instructions; SMS reminder at 3 months if no participation; Assistance provided for triage cytology if HPV positive. |
| Choice | Experimental | Other: Women receive invitation letter with choice of ordering a free self-sampling kit or visit healthcare providerWomen receive an invitation letter offering a choice between ordering a free self-sampling kit or visiting a healthcare provider. Option between self-sampling and healthcare provider: women can choose testing method. If self-sampling chosen, kit sent to home. SMS reminder at 3 months if no participation. |
| Control arm | No intervention | –Standard invitation to visit healthcare provider for cervical cancer screening. Standard screening procedure. Follow standard organized screening program procedure. HPV self-sampling offered at 12-month reminder if no participation. |
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 30 to 65 years old
- Living in the study area (Departments of Marne and Aube, France)
- At moderate risk of cervical cancer, i.e. eligible to the organised programme and receiving the first invitation of the screening round (not a reminder letter)
Key exclusion criteria (5 listed)
- Outside the target age (less than 30 years old, or 66 years old and more)
- Already participating in the current screening round
- Total hysterectomy
- History of cervical cancer
- Current follow-up for abnormal cervical screening result or cervical lesions
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 |
|---|---|---|
| Women receive invitation letter with HPV self-sampling kitDirect mailing of HPV self-sampling kit. Women receive HPV self-sampling kit with instructions. SMS reminder at 3 months if no participation. Assistance provided for triage cytology if HPV positive. | Other | Outreach |
| Women receive invitation letter with choice of ordering a free self-sampling kit or visit healthcare providerOption between self-sampling and healthcare provider: women can choose testing method. If self-sampling chosen, kit sent to home. SMS reminder at 3 months if no participation. | Other | Choice |
Primary outcome
Participation rate in cervical cancer screening
Time frame: 18 months after invitation
6 secondary outcomes
Triage cytology completion rate after positive HPV test
Time frame: 6 months after positive result
HPV positivity rate
Time frame: 12 months after invitation
Invalid result rate
Time frame: 18 months
Time from HPV-positive result to completion of cytological triage
Time frame: 18 months
Women's acceptability of HPV self-sampling
Time frame: 24 months
Cost-effectiveness of screening strategies
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 23 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Aurélie BERTRAND-BRICE, MD principal investigator
Regional Cancer Screening Coordinating Centre, Marne site
Christine CLAVEL CRAVOISIER, Professor principal investigator
CHU de Reims
Hamza ACHIT, PhD principal investigator
CHRU Nancy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Women receive invitation letter with HPV self-sampling kit and Women receive invitation letter with choice of ordering a free self-sampling kit or visit healthcare provider in people with Cervical Cancer, run by International Agency for Research on Cancer at 2 sites 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: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Farida Selmouni, PhD (+33 4 72738485, selmounif@iarc.who.int), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate in cervical cancer screening (time frame: 18 months after invitation). 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 23 Jul 2025.