Clinical trial · Interventional
SElf-SAMpling in Cervical Cancer Screening; SESAM Study
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study group
- description
- 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.
- interventionNames
- Device: HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens
Primary outcomes (1)
- 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
- description
- Relative sensitivity will be measured through histologically confirmed detection rates using clinician-sampled specimen as a reference.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Women with histological verified CIN 2 or CIN 3 * Women with histological verified cervical cancer Exclusion Criteria: * Women with mild cervical lesions
References
Publications (1)
- DERIVEDLeinonen 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. PMID 29289814