SElf-SAMpling in Cervical Cancer Screening; SESAM Study (SESAM)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Cancer | Device: HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens | Not Applicable |
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 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 |

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. |
- 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.
- 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.
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women with histological verified CIN 2 or CIN 3
- Women with histological verified cervical cancer
Exclusion Criteria:
- Women with mild cervical lesions

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
Norway | |
Ostfold Hospital Trust | |
Fredrikstad, Norway | |
Oslo University Hospital, Molecular Pathology | |
Oslo, Norway | |
Oslo University Hospital, Ullevål | |
Oslo, Norway | |
Radiumhospital | |
Oslo, Norway |
Study Director: | Giske Ursin, MD, Prof | Oslo University Hospital, Cancer Registry of Norway |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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. |
mass screening coverage self-sampling clinical validity |
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |