Reliability, validation and acceptance of a novel self-lavaging collection device, MySampleTM, in combination with the HPV-Risk Assay and QIAsure Methylation test to screen for cervical cancer.
- Conditions
- cervical cancer10013364
- Registration Number
- NL-OMON46230
- Lead Sponsor
- Maxima Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 200
* 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;
* 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* To assess the reliability of MySample (MySample BV, the Netherlands) used in<br /><br>home-setting, for hrHPV testing and methylation triage (HPV-Risk Assay and<br /><br>QIAsure Methylation test, Selfscreen, the Netherlands), using the<br /><br>clinician-collected brush as comparative method by calculating percent<br /><br>agreement and the kappa, stratified for CIN2+/CIN3+.<br /><br>* To clinically validate specimens self-collected with MySample by evaluating<br /><br>the sensitivity of hrHPV primary (HPV risk assay) for identifying CIN2+/CIN3+,<br /><br>as confirmed by colposcopy and biopsy. The relative sensitivity of hrHPV<br /><br>testing on MySample self-samples must be at least 90% compared to that of hrHPV<br /><br>testing on the clinician-collected brush samples as determined with the<br /><br>non-inferiority score test.</p><br>
- Secondary Outcome Measures
Name Time Method