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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02945891 |
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Date of registration:
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21/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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SElf-SAMpling in Cervical Cancer Screening; SESAM Study
SESAM |
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Scientific title:
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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 |
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Date of first enrolment:
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April 2014 |
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Target sample size:
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310 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02945891 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Norway
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Contacts
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Name:
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Giske Ursin, MD, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oslo University Hospital, Cancer Registry of Norway |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women with histological verified CIN 2 or CIN 3
- Women with histological verified cervical cancer
Exclusion Criteria:
- Women with mild cervical lesions
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cervical Cancer
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Intervention(s)
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Device: HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Participants screening history and reasons for possible non-participation
[Time Frame: Through study completion, an average of 6 months]
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Acceptability of feasibility of self-sampling
[Time Frame: Through study completion, an average of 6 months]
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Overall and hrHPV specific concordance between self- and clinician-sampled specimens
[Time Frame: Through study completion, an average of 6 months]
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Secondary ID(s)
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5777899
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2014/655
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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