cervical cancer
Conditions
Interventions
nvt
Sponsors
Maxima Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Colposcopy referral (> PAP 3A2 in the cervical cancer screening program, or at the gynecological outpatient department ) or healthy volunteer. * Scheduled appointment at the gynecological outpatient department of the participating hospital; * Between 30 and 65 years old; * Self-report being able to read in Dutch; * Willing to sign Informed Consent;
Exclusion criteria
Exclusion criteria: * No uterus / history of complete hysterectomy; * No previous treatment for CIN 2/CIN 3 * healthy volunteers; positive PAP-smear in the last 5 years. * Mental or physical handicap that would prevent self-collection of specimens;* Women are not allowed to use the self-sampling device when they are menstruating. Participants who are having their period between recruitment and the scheduled appointment will be instructed to take this into consideration, allowing at least one week interval between self-collection and hospital visit. * Women who use vaginal products (douche, spermicide, antifungal) will be instructed to wait for 48 hours before using the device. This does not include water-based lubricants or condoms and the NuvaRing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * To assess the reliability of MySample (MySample BV, the Netherlands) used in home-setting, for hrHPV testing and methylation triage (HPV-Risk Assay and QIAsure Methylation test, Selfscreen, the Netherlands), using the clinician-collected brush as comparative method by calculating percent agreement and the kappa, stratified for CIN2+/CIN3+. * To clinically validate specimens self-collected with MySample by evaluating the sensitivity of hrHPV primary (HPV risk assay) for identifying CIN2+/CIN3+, as confirmed by colposcopy and biopsy. The relative sensitivity of hrHPV testing on MySample self-samples must be at least 90% compared to that of hrHPV testing on the clinician-collected brush samples as determined with the non-inferiority score test. | — |
Secondary
| Measure | Time frame |
|---|---|
| * To compare the sensitivity and specificity of methylation triage (HPV-Risk in combination with QIAsure Methylation test) and the specificity of primary hrHPV testing (HPV-Rrisk assay) between the MySample specimens and clinician-collected specimens for identifying CIN2+ and CIN3+, as confirmed by colposcopy and biopsy. * To evaluate the acceptability of MySample compared to the pelvic examination; * To evaluate the Instructions for Use; * To evaluate the functionality of the novel MySample: the assembly of bottle to inserter, technical complaints; * To evaluate the acceptance, and validate the procedure to handle, store, process the specimen in the laboratory; * To measure the volume of fluid collected with MySample; * To measure pellet size; * To compare the percentage of indeterminate or insufficient specimen collections between MySample and clinician-collected specimens by b-globin testing; * To record any adverse event that occurs from use of the device, as a measurement of safety. | — |
Countries
Netherlands
Outcome results
None listed