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SElf-SAMpling in Cervical Cancer Screening; SESAM Study (SESAM)

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ClinicalTrials.gov Identifier: NCT02945891
Recruitment Status : Unknown
Verified April 2017 by Mari Nygård, Oslo University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 26, 2016
Last Update Posted : April 6, 2017
Sponsor:
Collaborator:
Ostfold Hospital Trust
Information provided by (Responsible Party):
Mari Nygård, Oslo University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Device: HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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
Study Start Date : April 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Study group
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.
 Device: HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens
Each woman use the self-sampling devices in an advised order the day before they go to the hospital. There will be change of sampling order with every patient so that 50% of women will use Evalyn®Brush (Rovers Medical Devices, Oss, The Netherlands) first and 50% a FloqSwab (Coban Flock Technologies, Italy) first. In addition women are asked to provide a first void urine sample using a Colli-PeeTM (Novosanis, Belgium) on the same morning as the hospital visit. At the hospital clinician will take an additional specimen for which the performance of different self-sampling devices will be compared to.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Relative sensitivity will be measured through histologically confirmed detection rates using clinician-sampled specimen as a reference.


Secondary Outcome Measures :
  1. Overall and hrHPV specific concordance between self- and clinician-sampled specimens [ Time Frame: 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.

  2. Acceptability of feasibility of self-sampling [ Time Frame: 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.

  3. Participants screening history and reasons for possible non-participation [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Women with mild cervical lesions
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945891


Locations
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Norway
Ostfold Hospital Trust
Fredrikstad, Norway
Oslo University Hospital, Molecular Pathology
Oslo, Norway
Oslo University Hospital, Ullevål
Oslo, Norway
Radiumhospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Ostfold Hospital Trust
Investigators
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Study Director: Giske Ursin, MD, Prof Oslo University Hospital, Cancer Registry of Norway
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mari Nygård, Senior Medical Officer, Head of HPV-related Epiemiological Research Unit, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02945891     History of Changes
Other Study ID Numbers: 2014/655
5777899 ( Other Grant/Funding Number: Cancer Society of Norway )
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We can`t make individual participant data available due to restrictions set by the ethical approval and the informed consent. Our data contains several variables with personal health information, including age, dates, test results and diagnoses. Even without direct identifiers, it would be possible for a person to recognize herself from the dataset and that is strictly forbidden.
Keywords provided by Mari Nygård, Oslo University Hospital:
mass screening
coverage
self-sampling
clinical validity
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female