Validation of DNA methylation analysis on self-collected vaginal specimens collected with Floqswab for cervical cancer detection
Cervical (pre)cancer
At least 70 high-risk HPV+ women with CIN3+ and 70 high-risk HPV+ women without evidence of disease (or at maximum CIN1; i.e. ≤CIN1) are required (n = 140 in total). HPV detection is not routinely performed at Tashkent. Therefore the colposcopic impression of women will be used to determine if women are eligible for study inclusion. Eligible women are asked to return for a second visit 2 weeks later to perform the sampling for the study. Eligible are women with a colposcopic impression of CIN3+ and women with a colposcopic impression that is normal or CIN1 (i.e., ≤CIN1). At the second visit of the eligible women both a vaginal self-sample collected with the Floqswab device and a physician-taken cervical smear are collected for high-risk HPV and methylation analysis. After this the women will receive their required diagnostic follow-up according to local guidelines and procedures. At the first visit the eligible women will not undergo biopsy, LEEP or any other interventional procedures as this interferes with the sampling after 2 weeks. Because high-risk HPV and methylation testing will be performed at Amsterdam University medical center (AUMC, Amsterdam, The Netherlands) the final sample selection for inclusion in the performance study is performed retrospectively based on HPV positivity with the clinically validated QIAscreen HPV PCR Test (Self-screen B.V., The Netherlands). It is estimated that approximately 250 women need to participate to obtain the 140 high-risk HPV-positive women. First visit: At first visit colposcopy with acetic acid and Lugol solution is performed (according to routine procedures). When the colposcopic impression of the cervix is CIN3+ or normal or CIN0/1 then women are eligible for study inclusion and are asked to return 2 weeks later for a second visit. These eligible women do not have interventional procedures (i.e., biopsy, LEEP, LLETZ, etc) at the first visit. Eligible women get a unique study ID number that is used for the rest of th
1. All women aged 25 years or older attending the Waylon women’s health clinic for their routine colposcopic examination of the cervix 2. Women with a colposcopic impression of CIN3+ 3. Women with a colposcopic impression that is normal or CIN1 4. Women who consented to participate in the study
1. Women with insufficient sample volume of clinician-taken and/or self-collected specimen for testing for high-risk HPV and methylation 2. Women who test high-risk HPV negative on their clinician-taken sample 3. Women who objected to the use of their personal data and/or sample material before, during or after the study