Cancer CervixAPACHE-3NCT02255084
Vaginal Self-sampling and Human Papillomavirus Testing in Unscreened Women
A study testing Group 1 remove self sample kit at gp consulting room or perform pap smear and Group 2 perform self sample at home or pap smear in people with Cancer Cervix, run by University Hospital, Tours at 1 site in France.
Trial summary
Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Cancer Cervix
- What is being tested?
- Group 1 remove self sample kit at gp consulting room or perform pap smear and Group 2 perform self sample at home or pap smear
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,612 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women from 30 to 65 years old
- women living in french territorial division 37 ("Indre-et-Loire")
- women having a reported general practitioner in french territorial division 37 ("Indre-et-Loire")
Who cannot join
- pap smear made in the three last years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attitude of Unscreened Women Face to Different Strategies to Participate in Cervical Cancer Screening by Vaginal Self-sampling : Home-mailed or Invitation to Remove to Their General Practitioner
Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with High-Risk Human PapillomaVirus oncogene (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal self-sampling with HPV test is a powerful means to increase the participation rate in cervical cancer screening.
- Conditions
- Cancer Cervix
- Being tested
- Group 1 remove self sample kit at gp consulting room or perform pap smear, Group 2 perform self sample at home or pap smear
- Keywords
- Cervical cancer screening, High Risk Human papillomavirus Infection, vaginal self-sampling, pap smear, general practitioner
- 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.
Group 1 remove self sample kit at gp consulting room or perform pap smearBehavioural
Selected general practitioners are briefly informed about the study and they receive a package of kits for vaginal self-sampling.
Selected women receive a mail inviting them either to remove a kit for vaginal self-sampling at their general practitioner's consulting room or to perform a pap smear. When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.
Group 2 perform self sample at home or pap smearBehavioural
Selected general practitioners are briefly informed about the study. Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (with the kit provided) or to perform a pap smear.
When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 remove self sample kit at gp consulting room or perform pap smear :
Study coordinators send mail inviting women to remove a kit for vaginal self-sampling at their general practitioner s consulting room.
Either a pap smear is perform or, at home, women perform vaginal self sampling. Then women send it to a central laboratory for HPV test (Human papillomaVirus). Receives: Behavioral: Group 1 remove self sample kit at gp consulting room or perform pap smear |
| Group 2 | Experimental | Group 2 perform self sample at home or pap smear :
Kit for vaginal self-sampling sent at women home. Women perform vaginal self sampling. Then women send it to a central laboratory for HPV test (Human papillomaVirus). Receives: Behavioral: Group 2 perform self sample at home or pap smear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation / no participation to complete cervical cancer screening
Uncompleted cervical cancer screening is defined as one of the followings :
- no pap smear
- no vaginal self-sampling
- noninterpretable HPV test result and no pap smear
- positive HPV test result and no control pap smear
Measured: 9 months after postal mail
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startFeb 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer CervixStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 3,612 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ken HAGUENOER, MD-PHD, Study director, Centre de coordination des dépistages des cancers, Tours, FranceSomany SENGCHANH, MD-PHD, Principal investigator, Centre de coordination des dépistages des cancers, Tours, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255084
- Sponsor's protocol ID
- INCA13-KH / APACHE-3
- Acronym
- APACHE-3
- Status last verified
- Dec 2025
- First submitted
- 29 Sep 2014
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Boyard J, Caille A, Brunet-Houdard S, Sengchanh-Vidal S, Giraudeau B, Marret H, Rolland-Lozachmeur G, Rusch E, Gaudy-Graffin C, Haguenoer K. A Home-Mailed Versus General Practitioner-Delivered Vaginal Self-Sampling Kit for Cervical Cancer Screening: A Cluster Randomized Controlled Trial with a Cost-Effectiveness Analysis. J Womens Health (Larchmt). 2022 Oct;31(10):1472-1480. doi: 10.1089/jwh.2021.0597. Epub 2022 Jul 13.
PubMed 35834620
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attitude of Unscreened Women Face to Different Strategies to Participate in Cervical Cancer Screening by Vaginal Self-sampling : Home-mailed or Invitation to Remove to Their General Practitioner
- ClinicalTrials.gov ID
- NCT02255084
- Acronym / sponsor ID
- APACHE-3 / INCA13-KH / APACHE-3
- Conditions
- Cancer Cervix
- Keywords
- Cervical cancer screening, High Risk Human papillomavirus Infection, vaginal self-sampling, pap smear, general practitioner
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,612 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Oct 2014 (estimated)
- 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.
Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with High-Risk Human PapillomaVirus oncogene (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal self-sampling with HPV test is a powerful means to increase the participation rate in cervical cancer screening.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Group 1 remove self sample kit at gp consulting room or perform pap smearGroup 1 remove self sample kit at gp consulting room or perform pap smear : Study coordinators send mail inviting women to remove a kit for vaginal self-sampling at their general practitioner s consulting room. Either a pap smear is perform or, at home, women perform vaginal self sampling. Then women send it to a central laboratory for HPV test (Human papillomaVirus). |
| Group 2 | Experimental | Behavioral: Group 2 perform self sample at home or pap smearGroup 2 perform self sample at home or pap smear : Kit for vaginal self-sampling sent at women home. Women perform vaginal self sampling. Then women send it to a central laboratory for HPV test (Human papillomaVirus). |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women from 30 to 65 years old
- women living in french territorial division 37 ("Indre-et-Loire")
- women having a reported general practitioner in french territorial division 37 ("Indre-et-Loire")
Key exclusion criteria (1 listed)
- pap smear made in the three last years
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 |
|---|---|---|
| Group 1 remove self sample kit at gp consulting room or perform pap smearSelected general practitioners are briefly informed about the study and they receive a package of kits for vaginal self-sampling. Selected women receive a mail inviting them either to remove a kit for vaginal self-sampling at their general practitioner's consulting room or to perform a pap smear. When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory. | Behavioural | Group 1 |
| Group 2 perform self sample at home or pap smearSelected general practitioners are briefly informed about the study. Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (with the kit provided) or to perform a pap smear. When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory. | Behavioural | Group 2 |
Primary outcome
Participation / no participation to complete cervical cancer screening
Time frame: 9 months after postal mail
Uncompleted cervical cancer screening is defined as one of the followings : * no pap smear * no vaginal self-sampling * noninterpretable HPV test result and no pap smear * positive HPV test result and no control pap smear
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 35834620Boyard J, Caille A, Brunet-Houdard S, Sengchanh-Vidal S, Giraudeau B, Marret H, Rolland-Lozachmeur G, Rusch E, Gaudy-Graffin C, Haguenoer K. A Home-Mailed Versus General Practitioner-Delivered Vaginal Self-Sampling Kit for Cervical Cancer Screening: A Cluster Randomized Controlled Trial with a Cost-Effectiveness Analysis. J Womens Health (Larchmt). 2022 Oct;31(10):1472-1480. doi: 10.1089/jwh.2021.0597. Epub 2022 Jul 13.
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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.
Ken HAGUENOER, MD-PHD study director
Centre de coordination des dépistages des cancers, Tours, France
Somany SENGCHANH, MD-PHD principal investigator
Centre de coordination des dépistages des cancers, Tours, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 remove self sample kit at gp consulting room or perform pap smear and Group 2 perform self sample at home or pap smear in people with Cancer Cervix, run by University Hospital, Tours 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 1 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: finished, as of the sponsor's last update on 22 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participation / no participation to complete cervical cancer screening (time frame: 9 months after postal mail). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02255084, which also lists 1 linked publication.
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 22 Dec 2025.