SElf-SAMpling in Cervical Cancer Screening; SESAM Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Device: HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with histological verified CIN 2 or CIN 3 Women with histological verified cervical cancer Exclusion Criteria: Women with mild cervical lesions
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Each women recruited for the study belong to the study group. Intervention is performance of HPV testing on Evalyn®Brush and FloqSwab specimens compared to clinician-sampled specimen. Providing an urinary sample (Colli-PeeTM), blood, and a questionnaire data is optional. | Device: HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens<br>* Each woman use the self-sampling devices in an advised order the day before they go to the hospital. There will be change of sampling order with every patient so that 50% of women will use Evalyn®Brush (Rovers Medical Devices, Oss, The Netherlands) first and 50% a FloqSwab (Coban Flock Technologies, Italy) first. In addition women are asked to provide a first void urine sample using a Colli-PeeTM (Novosanis, Belgium) on the same morning as the hospital visit. At the hospital clinician will take an additional specimen for which the performance of different self-sampling devices will be compared to.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High-risk HPV (hrHPV) testing on self-sampled specimens has non-inferior sensitivity for CIN 2+ compared to clinician-sampled specimens. | Relative sensitivity will be measured through histologically confirmed detection rates using clinician-sampled specimen as a reference. | Sensitivity will be assessed through study completion, up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall and hrHPV specific concordance between self- and clinician-sampled specimens | Agreement of hrHPV positivity rates between self-collected samples and physician-collected reference samples will be assessed by the kappa statistic. | Through study completion, an average of 6 months | 
| Acceptability of feasibility of self-sampling | We will evaluate the acceptability of different self-sampling devices based on the participants' views from a questionnaire. | Through study completion, an average of 6 months | 
| Participants screening history and reasons for possible non-participation | We will evaluate reasons for possible non-participation based on the participants' responses from a questionnaire and individual screening records at the Cancer Registry of Norway. | Through study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mass screening, coverage, self-sampling, clinical validity