Vaginal Self-sampling and Human Papillomavirus Testing in Unscreened Women

Not Applicable

Completed

• Conditions: Cancer Cervix
• Interventions: Behavioral: Group 2 perform self sample at home or pap smear; Behavioral: Group 1 remove self sample kit at gp consulting room or perform pap smear

• Registration Number: NCT02255084
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2014-10-01
• Study First Posted: 2014-10-02
• Study Start: 2015-02
• Status Verified: 2016-08
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3612

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Group 2 perform self sample at home or pap smear	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).
Group 1	Group 1 remove self sample kit at gp consulting room or perform pap smear	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).

Primary Outcome Measures

Name	Time	Method
Participation / no participation to complete cervical cancer screening	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

Trial Locations

Locations (1)

UH Tours; 🇫🇷 Tours, Indre et Loire, France