Cancer Cervix
Conditions
Keywords
Cervical cancer screening, High Risk Human papillomavirus Infection, vaginal self-sampling, pap smear, general practitioner
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.
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.
Sponsors
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
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
* pap smear made in the three last years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed