Vaginal Self-sampling and Human Papillomavirus Testing in Unscreened Women

Cancer Cervix Clinical Trial

— APACHE-3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02255084
• Other study ID #: INCA13-KH / APACHE-3
• Status: Completed
• Phase: N/A
• First received: September 29, 2014
• Last updated: October 25, 2016
• Start date: February 2015
• Est. completion date: September 2016

Study information

• Verified date: August 2016
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3612
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Cancer Cervix

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	UH Tours	Tours	Indre et Loire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	9 months after postal mail	No