Spots Global Cancer Trial Database for SElf-SAMpling in Cervical Cancer Screening; SESAM Study

Study Description

Brief Summary: Study aims to support development of evidence based health care in Norway through evaluating recently proposed technological improvements in cervical cancer control before their routine use. SESAM II study evaluates the accuracy of vaginal self-sampling for high risk human papillomavirus (hrHPV) testing compared with a physician-taken sample.

Detailed Description: Concept of collecting cervical cancer screening smear in home through self-sampling is new both for target population and medical professionals. Self-sampling increases screening attendance and could be an alternative to recruit more women to cervical cancer screening in Norway. As there are is an implementation ongoing to switch from cytology based screening to HPV based screening in Norway, a reliable self-sampling method for HPV testing should be available. Furthermore, detection of HPV from self-sampled specimen requires laboratory capacity and expertise to comply with quality assurance demands such as internal quality control, external quality assessment and quality improvement. National studies are crucial to obtain knowledge and build expertize among health care providers. This study aims to show non-inferior sensitivity of hrHPV testing on self-sampled vs. clinician-sampled specimens to detect high-grade cervical lesions and cancer (CIN2+). Additionally we will; * Evaluate overall and hrHPV type specific concordance between self-taken and physician-taken samples. * Evaluate participants views on feasibility and acceptability of self-sampling (questionnaire) * Compare participants screening history with the questionnaire to evaluate the reason for not participating in the national screening program (if that is the case). * Biobank biological material collected from self-sample, physician taken samples, blood and urine, for future analysis on HPV-related diseases and cancer. Study participants will be recruited from the colposcopy referrals and cancer care units from three different hospitals. Patients with CIN 2 or CIN 3 lesions (n=200) will be recruited from Oslo University Hospital, Ullevål and Østfold Hospital Trust, while cancer patients (n=50) will be recruited from Radiumhospital.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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