Validation of Human Papillomavirus Assays and Collection Devices for Self-samples and Urine Samples
Validation of Human Papillomavirus Assays and Collection Devices for Self-samples and Urine Samples
The VALHUDES study is a Diagnostic Test Accuracy study that aims to document the clinical
 accuracy of hrHPV testing on urine samples, collected under standardised and optimised
 conditions, and on two types of vaginal self-samples and compare results with those from
 matching samples taken by a clinician.
The samples are collected from patients referred to colposcopy because of prior cervical
 abnormalities. The patient takes at home two urine samples with the Colli-Pee device (a
 device that allows to collect first-void urine), the day before the visit to the colposcopy
 centre. At the colposcopy centre, two vaginal self-samples are taken by the patient herself:
 one with a cotton swab and a second with a plastic brush. Finally, the gynecologist takes a
 cervical Pap smear with a Cervex-Brush Combi.

 A real-time PCR test will be used to detect DNA of high-risk HPV types. It is possible that
 in the future also other tests will be validated on these samples. The colposcopy and
 histological findings will be used as the gold standard. The main purpose of the study is to
 assess the relative diagnostic tests accuracy of hrHPV testing on self- and urine samples
 compared to hrHPV testing on cervical samples taken by a clinician. Furthermore, the
 participating women will receive also a questionnaire which can give insights into the
 attitudes and preferences of the women with regard to the self-sampling devices.
Inclusion Criteria:

 -  Women with previous abnormal cervical cancer screening test results

 -  Women between the ages of 25 and 64

 Exclusion Criteria:

 -  Hysterectomised women

 -  Women with known pregnancy

 -  Non-consenting women

 -  Women that are not able to understand and to sign the informed consent