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

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Cancer Cervix

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT02255084

INCA13-KH / APACHE-3

Details and patient eligibility

About

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.

Enrollment: 3,612 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,612 participants in 2 patient groups

Group 1

Experimental group

Description:

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).

Treatment:

Behavioral: Group 1 remove self sample kit at gp consulting room or perform pap smear

Group 2

Experimental group

Description:

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).

Treatment:

Behavioral: Group 2 perform self sample at home or pap smear