SElf-SAMpling in Cervical Cancer Screening; SESAM Study (SESAM)
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|ClinicalTrials.gov Identifier: NCT02945891|
Recruitment Status : Unknown
Verified April 2017 by Mari Nygård, Oslo University Hospital.
Recruitment status was: Active, not recruiting
First Posted : October 26, 2016
Last Update Posted : April 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Device: HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||310 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||April 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
Experimental: Study group
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
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.
- High-risk HPV (hrHPV) testing on self-sampled specimens has non-inferior sensitivity for CIN 2+ compared to clinician-sampled specimens. [ Time Frame: Sensitivity will be assessed through study completion, up to 36 months ]Relative sensitivity will be measured through histologically confirmed detection rates using clinician-sampled specimen as a reference.
- Overall and hrHPV specific concordance between self- and clinician-sampled specimens [ Time Frame: Through study completion, an average of 6 months ]Agreement of hrHPV positivity rates between self-collected samples and physician-collected reference samples will be assessed by the kappa statistic.
- Acceptability of feasibility of self-sampling [ Time Frame: Through study completion, an average of 6 months ]We will evaluate the acceptability of different self-sampling devices based on the participants` views from a questionnaire.
- Participants screening history and reasons for possible non-participation [ Time Frame: Through study completion, an average of 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945891
|Ostfold Hospital Trust|
|Oslo University Hospital, Molecular Pathology|
|Oslo University Hospital, Ullevål|
|Study Director:||Giske Ursin, MD, Prof||Oslo University Hospital, Cancer Registry of Norway|