Cervical Cancer Clinical Trial
— SESAMOfficial 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
Verified date | April 2017 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 310 |
Est. completion date | December 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Women with histological verified CIN 2 or CIN 3 - Women with histological verified cervical cancer Exclusion Criteria: - Women with mild cervical lesions |
Country | Name | City | State |
---|---|---|---|
Norway | Ostfold Hospital Trust | Fredrikstad | |
Norway | Oslo University Hospital, Molecular Pathology | Oslo | |
Norway | Oslo University Hospital, Ullevål | Oslo | |
Norway | Radiumhospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | Ostfold Hospital Trust |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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