SElf-SAMpling in Cervical Cancer Screening; SESAM Study
SElf-SAMpling in Cervical Cancer Screening; SESAM Study
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.
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.
Inclusion Criteria:

 -  Women with histological verified CIN 2 or CIN 3

 -  Women with histological verified cervical cancer

 Exclusion Criteria:

 -  Women with mild cervical lesions