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Vaginal Self-sampling and Human Papillomavirus Testing in Unscreened Women (APACHE-3)

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ClinicalTrials.gov Identifier: NCT02255084
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Cervix Behavioral: Group 1 remove self sample kit at gp consulting room or perform pap smear Behavioral: Group 2 perform self sample at home or pap smear Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3612 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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
Study Start Date : February 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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.


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

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.





Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

  • pap smear made in the three last years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255084


Locations
France
UH Tours
Tours, Indre et Loire, France, 37000
Sponsors and Collaborators
University Hospital, Tours
Investigators
Study Director: Ken HAGUENOER, MD-PHD Centre de coordination des dépistages des cancers, Tours, France
Principal Investigator: Somany SENGCHANH, MD-PHD Centre de coordination des dépistages des cancers, Tours, France

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT02255084     History of Changes
Other Study ID Numbers: INCA13-KH / APACHE-3
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: August 2016

Keywords provided by University Hospital, Tours:
Cervical cancer screening
High Risk Human papillomavirus Infection
vaginal self-sampling
pap smear
general practitioner