Vaginal Self-sampling and Human Papillomavirus Testing in Unscreened Women
- Conditions
- Cancer Cervix
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3612
- 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")
- pap smear made in the three last years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UH Tours
🇫🇷Tours, Indre et Loire, France
UH Tours🇫🇷Tours, Indre et Loire, France