Coordinating investigator:
Prof. Peter Snijders (VU University Medical Centre, the Netherlands)
Several trials on programme non-attendees have shown that offering self-sampling for HPV testing is a feasible and effective method for increasing the screening coverage and detection of cancer precursor lesions.
Self-sampling also has potential as a screening method for the general screening population but no randomized trials have been performed. It is important to evaluate whether the clinical accuracy of the HPV test on self-collected material is non-inferior to the clinical accuracy on physician-collected material.
A randomized-controlled trial will be performed comparing self-sampling to physician-based sampling for hrHPV testing as first screening test. Women who accept to participate in the study will be randomly assigned to self-collection at home or physician-collection at the general practitioners office. All women who test HPV positive will receive the second screening test, a PAP smear and will be referred for intensified follow-up or treatment if needed. Women who test HPV positive will also be asked to perform the other HPV sampling method one months later – thus HPV positive women who were randomized to self-sampling will be asked to go for physician-based sampling, and HPV positive women who were randomized to physician-based sampling will be asked to self-collect a sample. It will be assessed if the test performance for detecting (pre) cancerous lesions via self-sampling is non-inferior to the performance of physician-sampling. Two different self-sampling devices will be evaluated.
The study will be conducted in the Netherlands and in Finland. In total 40,000 women will be invited to participate in this study and it will take one and a half year to complete.
HPV self-sampling study
Study design: