SElf-SAMpling in Cervical Cancer Screening; SESAM Study

University of Oslo (UIO)

Status: Unknown

Conditions: Cervical Cancer

Treatments: Device: HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens

Study type: Interventional

Funder types: Other

Identifiers

NCT02945891

2014/655

5777899 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 310 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Women with mild cervical lesions

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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310 participants in 1 patient group

Study group

Experimental 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.

Treatment:

Device: HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens