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. - CESSAR (CErvical Self Sampling Reliability)

Maxima Medisch Centrum0 个研究点目标入组 200 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•* 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.

发起方

Maxima Medisch Centrum