Clinical trial NCT02945891: SElf-SAMpling in Cervical Cancer Screening; SESAM Study
Official title: SElf-SAMpling in Cervical Cancer Screening. SESAM Study; a Key to Better Health. Clinical Validation of a Self-sampling Device in Patients With Cervical Cancer and Cervical Pre-invasive Neoplasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
Keywords: mass screening
coverage
self-sampling
clinical validity
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Ostfold Hospital Trust
First posted: 2016-10-26
Enrollment: 310
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* Women with histological verified CIN 2 or CIN 3
* Women with histological verified cervical cancer

Exclusion Criteria:

* Women with mild cervical lesions

Primary outcomes:
measure: High-risk HPV (hrHPV) testing on self-sampled specimens has non-inferior sensitivity for CIN 2+ compared to clinician-sampled specimens.
timeFrame: Sensitivity will be assessed through study completion, up to 36 months
Secondary outcomes:
measure: Overall and hrHPV specific concordance between self- and clinician-sampled specimens
timeFrame: Through study completion, an average of 6 months
measure: Acceptability of feasibility of self-sampling
timeFrame: Through study completion, an average of 6 months
measure: Participants screening history and reasons for possible non-participation
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Fredrikstad
country: Norway
facility: Ostfold Hospital Trust
city: Oslo
country: Norway
facility: Oslo University Hospital, Molecular Pathology
city: Oslo
country: Norway
facility: Oslo University Hospital, Ullevål
city: Oslo
country: Norway
facility: Radiumhospital
Study officials:
affiliation: Oslo University Hospital, Cancer Registry of Norway
name: Giske Ursin, MD, Prof
role: STUDY_DIRECTOR
References:
citation: Leinonen MK, Schee K, Jonassen CM, Lie AK, Nystrand CF, Rangberg A, Furre IE, Johansson MJ, Trope A, Sjoborg KD, Castle PE, Nygard M. Safety and acceptability of human papillomavirus testing of self-collected specimens: A methodologic study of the impact of collection devices and HPV assays on sensitivity for cervical cancer and high-grade lesions. J Clin Virol. 2018 Feb-Mar;99-100:22-30. doi: 10.1016/j.jcv.2017.12.008. Epub 2017 Dec 21.