SElf-SAMpling in Cervical Cancer Screening; SESAM Study

Not Applicable

• Conditions: Cervical Cancer
• Interventions: Device: HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens

• Registration Number: NCT02945891
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2016-10-21
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-26
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-06
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 310

Inclusion Criteria

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

Exclusion Criteria

• Women with mild cervical lesions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens	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.

Primary Outcome Measures

Name	Time	Method
High-risk HPV (hrHPV) testing on self-sampled specimens has non-inferior sensitivity for CIN 2+ compared to clinician-sampled specimens.	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.

Secondary Outcome Measures

Name	Time	Method
Overall and hrHPV specific concordance between self- and clinician-sampled specimens	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.
Participants screening history and reasons for possible non-participation	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.
Acceptability of feasibility of self-sampling	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.

Trial Locations

Locations (4)

Ostfold Hospital Trust; 🇳🇴 Fredrikstad, Norway

Oslo University Hospital, Ullevål; 🇳🇴 Oslo, Norway

Oslo University Hospital, Molecular Pathology; 🇳🇴 Oslo, Norway

Radiumhospital; 🇳🇴 Oslo, Norway