Cervical CancerSESAMNCT02945891
SElf-SAMpling in Cervical Cancer Screening; SESAM Study
A study testing HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens in people with Cervical Cancer, run by Oslo University Hospital at 4 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 4 sitesNorway
- Study dates
- Apr 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women with histological verified CIN 2 or CIN 3
- Women with histological verified cervical cancer
Who cannot join
- Women with mild cervical lesions
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Ostfold Hospital Trust
Fredrikstad
Oslo University Hospital, Molecular Pathology
Oslo
Oslo University Hospital, Ullevål
Oslo
Radiumhospital
Oslo
About this study
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 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.
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens
- Keywords
- mass screening, coverage, self-sampling, clinical validity
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimensDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | 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. Receives: Device: HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Sensitivity will be assessed through study completion, up to 36 months
Secondary outcomes (3)
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.
Measured: Through study completion, an average of 6 months
Acceptability of feasibility of self-sampling
We will evaluate the acceptability of different self-sampling devices based on the participants' views from a questionnaire.
Measured: Through study completion, an average of 6 months
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.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startApr 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ostfold Hospital Trust
- Responsible party
- Principal investigator, Mari Nygård, Oslo University Hospital
- Investigators
- Giske Ursin, MD, Prof, Study director, Oslo University Hospital, Cancer Registry of Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945891
- Sponsor's protocol ID
- 2014/655
- Other IDs
- 5777899
- Acronym
- SESAM
- Status last verified
- Apr 2017
- First submitted
- 21 Oct 2016
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Publications
Leinonen MK, Schee K, Jonassen CM, Lie AK, Nystrand CF, Rangberg A, Furre IE, Johansson MJ, Trope A, Sjoborg KD, Castle PE, Nygard M. Safety and acceptability of human papillomavirus testing of self-collected specimens: A methodologic study of the impact of collection devices and HPV assays on sensitivity for cervical cancer and high-grade lesions. J Clin Virol. 2018 Feb-Mar;99-100:22-30. doi: 10.1016/j.jcv.2017.12.008. Epub 2017 Dec 21.
PubMed 29289814
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02945891
- Acronym / sponsor ID
- SESAM / 2014/655
- Conditions
- Cervical Cancer
- Keywords
- mass screening, coverage, self-sampling, clinical validity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Ostfold Hospital Trust
- Study start
- Apr 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimensEach 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Women with histological verified CIN 2 or CIN 3
- Women with histological verified cervical cancer
Key exclusion criteria (1 listed)
- Women with mild cervical lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimensEach 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. | Device | Study group |
Primary outcome
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.
3 secondary outcomes
Overall and hrHPV specific concordance between self- and clinician-sampled specimens
Time frame: Through study completion, an average of 6 months
Acceptability of feasibility of self-sampling
Time frame: Through study completion, an average of 6 months
Participants screening history and reasons for possible non-participation
Time frame: Through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Derived from this study: PubMed 29289814Leinonen MK, Schee K, Jonassen CM, Lie AK, Nystrand CF, Rangberg A, Furre IE, Johansson MJ, Trope A, Sjoborg KD, Castle PE, Nygard M. Safety and acceptability of human papillomavirus testing of self-collected specimens: A methodologic study of the impact of collection devices and HPV assays on sensitivity for cervical cancer and high-grade lesions. J Clin Virol. 2018 Feb-Mar;99-100:22-30. doi: 10.1016/j.jcv.2017.12.008. Epub 2017 Dec 21.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giske Ursin, MD, Prof study director
Oslo University Hospital, Cancer Registry of Norway
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens in people with Cervical Cancer, run by Oslo University Hospital at 4 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02945891, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.