The National Cancer Institute in France (INCa) has asked the Cancer Society of the Ardennes Region (SAC08) to initiate a pilot study for population based cervical cancer screening. In this study, the Delphi Screener will be used as self-sampling method.

The SAC08 (Dr. E Rousselot-Marche and Mrs. B Charlier), CHU Reims (Pr. C Clavel and Dr. V Dalstein), Réseau ONCOCHA, pathologists, gynecologists and the general practitioners cooperate to start the population based trial in which the introduction of an invitation-based screening program will be evaluated.

Fifty thousand women between 25 and 65 years old who have not had a Pap smear in the past 3 years, will receive a letter inviting them to visit their general practitioner or gynecologist for a smear. Women who do not respond to this invitation will receive a second invitation after 4 months. A third invitation will be sent after 8 months to women who still do not respond, in which self-sampling is offered with the Delphi Screener.

Previous trials in several countries have shown that many women do not respond to an invitation for a smear at the clinic due to barriers like embarrassment, culture, lack of time and fear. The Delphi Screener can take away these barriers, resulting in an increase of the screening coverage.

In this trial the Hybrid Capture 2 assay of Qiagen will be used for HPV testing. The goal of the study is to evaluate in a general population, the feasibility of primary HPV testing with cytological triage  in women 31-65 years. Evaluation of responses to the invitations, follow-up management, large screening intervals (5 years) for women with a negative HPV test and ownership of HPV testing by the physicians and women will be also analyzed. The study started in May 2012 and is expected to run for the next 2 years. The population studied is refractory to screening, offering the Delphi Screener method to women aims to increase participation to cervical cancer screening in this population.

The Delphi Screener is the most widely validated primary cervical cancer screening method besides the traditional Pap smear. Screening is based on the unique lavage-based, soft, a-traumatic sampling method and a validated high risk Human Papilloma Virus test for this sampling platform. The Delphi Screener is more sensitive to detect women at risk than traditional Pap smear and as reliable as an HPV-test on a doctor’s collected sample.