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CompletedNCT02255084APACHE-3Updated Dec 22, 2025

Vaginal Self-sampling and Human Papillomavirus Testing in Unscreened Women

An interventional study of 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 Cancer Cervix, sponsored by University Hospital, Tours. Completed at 1 site in France. Open to female participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by University Hospital, Tours · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
3,612
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
Female
01

Study 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). 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.

02

Conditions studied

  • Cancer Cervix

Keywords

  • Cervical cancer screening
  • High Risk Human papillomavirus Infection
  • vaginal self-sampling
  • pap smear
  • general practitioner
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In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 3,612 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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")

Exclusion criteria

Exclusion Criteria:

  • pap smear made in the three last years
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,612 participants (actual)

Study arms

  • Experimental
    Group 1

    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).

    Behavioral: Group 1 remove self sample kit at gp consulting room or perform pap smear

  • Experimental
    Group 2

    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).

    Behavioral: Group 2 perform self sample at home or pap smear

Interventions

  • BehavioralGroup 1 remove self sample kit at gp consulting room or perform pap smear

    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.

  • BehavioralGroup 2 perform self sample at home or pap smear

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 9 months after postal mail

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Study locations

1 site
  • UH Tours
    Tours, Indre Et Loire 37000, France
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02255084
Lead sponsor
University Hospital, Tours
Responsible party
Sponsor
First posted
Oct 2, 2014
Start date
Feb 2015
Primary completion
Sep 2016
Completion
Sep 2016
Last update
Dec 22, 2025

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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