Cervical CancerNCT03873376
Self-sampling Among Long-term Non-attenders to Cervical Cancer Screening
A study testing Opt-in; Receive offer to order self-sampling kit and Opt-out; Receive self-sampling kit unsolicited in people with Cervical Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The trial will evaluate whether human papillomavirus (HPV) self-sampling may increase cervical cancer screening attendance among under-screened women in Norway, how different ways of offering self-sampling and follow-up may affect attendance, and whether self-sampling may reduce inequities in attendance. Read more about this study
- Who is it for?
- Ages 35 to 69 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Opt-in; Receive offer to order self-sampling kit and Opt-out; Receive self-sampling kit unsolicited
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,669 participants
- Where
- 1 siteNorway
- Study dates
- 11 Mar 2019to 30 Dec 2020
- 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 35 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women living in the regions Hordaland, Vest-Agder, Rogaland or Sør-Trøndelag, who have been eligible for screening in Norway, but who have not attended screening for at least 10 years (2009-2018)
Who cannot join
- Women who have not been eligible for cervical cancer screening during the entire 10 year period (2009-2018)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pragmatic Randomized Controlled Trial of Self-sampling Among Long-term Non-attenders to Cervical Cancer Screening
The trial will evaluate whether human papillomavirus (HPV) self-sampling may increase cervical cancer screening attendance among under-screened women in Norway, how different ways of offering self-sampling and follow-up may affect attendance, and whether self-sampling may reduce inequities in attendance.
Read the detailed description
A randomized control trial will be performed on the effect of vaginal HPV self-sampling on screening attendance, targeting women age 35-69 who have not attended screening for at least 10 years. The women will be randomly allocated to one of three interventions: (i) receive a reminder to be screened by a physician; (ii) receive a self-sampling kit; (iii) receive an offer to order a self-sampling kit. Comparisons of the screening attendance among the interventions will be made. To also address potential effects on inequities, the analyses will include comparisons by sociodemographic characteristics. The rates of cervical cancer/precancer among the interventions will also be compared. Further, to assess the feasibility of and the compliance to follow-up after a positive HPV test in this population, half of the HPV-positive women from each self-sampling arm will be referred to initial follow-up by their regular general practitioner (GP), while the other half will be referred to initial follow-up by a gynecologist. The project will be embedded in the national cervical cancer screening program, and will utilize the extensive nationwide registers describing performance and outcomes of screening collected by the Cancer Registry of Norway.
- Conditions
- Cervical Cancer
- Being tested
- Opt-in; Receive offer to order self-sampling kit, Opt-out; Receive self-sampling kit unsolicited, Control; Receive open reminder to be screened by physician
- Keywords
- mass screening, non-attendance, self-sampling, HPV
- 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.
Opt-in; Receive offer to order self-sampling kitBehavioural
Women in the opt-in arm receive an offer to order a HPV self-sampling kit, in addition to information about the study. Women who order, receive a kit that includes a self-sampling brush (Evalyn, Rovers Medical Devices), with instructions for use and a pre-paid envelope for returning the brush for HPV testing. The women are also informed that they can attend ordinary screening, i.e. performed by a physician. Women who choose self-sampling and test positive for high-risk HPV will be 1:1 allocated to follow-up by their general practitioner or a gynecologist. Women who test negative for high-risk HPV return to the ordinary screening program
Opt-out; Receive self-sampling kit unsolicitedBehavioural
Women in the opt-out arm receive the self-sampling kit directly, without having ordered it themselves. The kit has the same contents, and the follow-up is the same, as that described for the opt-in arm.
Control; Receive open reminder to be screened by physicianBehavioural
Similar to the procedure of the national screening program, women in the control arm receive a reminder to be screened by their general practitioner, and continues in the ordinary screening program
| Study group | Role | What they receive |
|---|---|---|
| Opt-in | Experimental | Receive offer to order self-sampling kit Receives: Behavioral: Opt-in; Receive offer to order self-sampling kit |
| Opt-out | Experimental | Receive self-sampling kit unsolicited Receives: Behavioral: Opt-out; Receive self-sampling kit unsolicited |
| Control | Experimental | Receive open reminder to be screened by physician Receives: Behavioral: Control; Receive open reminder to be screened by physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening attendance rate (%)
The primary outcome measure is the attendance rate to cervical cancer screening. Attendance is defined as returning a self-sampling test, or being screened by a physician during the 6 months following receipt of the invitation letter
Measured: 6 months
Secondary outcomes (3)
Prevalence of high-risk HPV (%)
Self-samples as well as physician-taken samples will be tested for high-risk HPV with the Cobas 4800 HPV-DNA test at the national HPV reference laboratory
Measured: 6 months
Prevalence of CIN2+ (proportion of cervical intraepithelial neoplasia grade 2 or worse)
Histologically confirmed CIN2+ diagnoses of all study participants who are eligible for follow-up will be retrieved from the cervical screening registry at the Cancer Registry of Norway
Measured: 6 months
Compliance to clinical follow-up of a high-risk HPV positive screening test (%)
Attendance to follow-up among women with a positive screening test will be surveyed following notification of the positive test result. In addition to comparing arms, we will compare compliance of women in the self-sampling arms who are followed up by their regular GP vs. women who are followed up by a gynecologist
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start11 Mar 2019
- Primary completion28 Feb 2020
- Study completion30 Dec 2020
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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,669 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Akershus, University of Oslo, University of Bergen, Albert Einstein College of Medicine, Norwegian Institute of Public Health
- Responsible party
- Principal investigator, Bo Terning Hansen, Oslo University Hospital
- Investigators
- Giske Ursin, MD, Prof, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873376
- Sponsor's protocol ID
- 18/14056
- Other IDs
- 182687
- Status last verified
- Apr 2022
- First submitted
- 8 Mar 2019
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aasbo G, Trope A, Nygard M, Christiansen IK, Baasland I, Iversen GA, Munk AC, Christiansen MH, Presthus GK, Undem K, Bjorge T, Castle PE, Hansen BT. HPV self-sampling among long-term non-attenders to cervical cancer screening in Norway: a pragmatic randomised controlled trial. Br J Cancer. 2022 Nov;127(10):1816-1826. doi: 10.1038/s41416-022-01954-9. Epub 2022 Aug 23.
PubMed 35995936
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Controlled Trial of Self-sampling Among Long-term Non-attenders to Cervical Cancer Screening
- ClinicalTrials.gov ID
- NCT03873376
- Acronym / sponsor ID
- 18/14056
- Conditions
- Cervical Cancer
- Keywords
- mass screening, non-attendance, self-sampling, HPV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,669 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Akershus, University of Oslo, University of Bergen, Albert Einstein College of Medicine, Norwegian Institute of Public Health
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 13 Mar 2019 (actual)
- 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.
The trial will evaluate whether human papillomavirus (HPV) self-sampling may increase cervical cancer screening attendance among under-screened women in Norway, how different ways of offering self-sampling and follow-up may affect attendance, and whether self-sampling may reduce inequities in attendance.
Detailed description
A randomized control trial will be performed on the effect of vaginal HPV self-sampling on screening attendance, targeting women age 35-69 who have not attended screening for at least 10 years. The women will be randomly allocated to one of three interventions: (i) receive a reminder to be screened by a physician; (ii) receive a self-sampling kit; (iii) receive an offer to order a self-sampling kit. Comparisons of the screening attendance among the interventions will be made. To also address potential effects on inequities, the analyses will include comparisons by sociodemographic characteristics. The rates of cervical cancer/precancer among the interventions will also be compared. Further, to assess the feasibility of and the compliance to follow-up after a positive HPV test in this population, half of the HPV-positive women from each self-sampling arm will be referred to initial follow-up by their regular general practitioner (GP), while the other half will be referred to initial follow-up by a gynecologist. The project will be embedded in the national cervical cancer screening program, and will utilize the extensive nationwide registers describing performance and outcomes of screening collected by the Cancer Registry of Norway.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Opt-in | Experimental | Behavioral: Opt-in; Receive offer to order self-sampling kitReceive offer to order self-sampling kit |
| Opt-out | Experimental | Behavioral: Opt-out; Receive self-sampling kit unsolicitedReceive self-sampling kit unsolicited |
| Control | Experimental | Behavioral: Control; Receive open reminder to be screened by physicianReceive open reminder to be screened by physician |
Who may qualify
- Ages
- 35 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women living in the regions Hordaland, Vest-Agder, Rogaland or Sør-Trøndelag, who have been eligible for screening in Norway, but who have not attended screening for at least 10 years (2009-2018)
Key exclusion criteria (1 listed)
- Women who have not been eligible for cervical cancer screening during the entire 10 year period (2009-2018)
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 |
|---|---|---|
| Opt-in; Receive offer to order self-sampling kitWomen in the opt-in arm receive an offer to order a HPV self-sampling kit, in addition to information about the study. Women who order, receive a kit that includes a self-sampling brush (Evalyn, Rovers Medical Devices), with instructions for use and a pre-paid envelope for returning the brush for HPV testing. The women are also informed that they can attend ordinary screening, i.e. performed by a physician. Women who choose self-sampling and test positive for high-risk HPV will be 1:1 allocated to follow-up by their general practitioner or a gynecologist. Women who test negative for high-risk HPV return to the ordinary screening program | Behavioural | Opt-in |
| Opt-out; Receive self-sampling kit unsolicitedWomen in the opt-out arm receive the self-sampling kit directly, without having ordered it themselves. The kit has the same contents, and the follow-up is the same, as that described for the opt-in arm. | Behavioural | Opt-out |
| Control; Receive open reminder to be screened by physicianSimilar to the procedure of the national screening program, women in the control arm receive a reminder to be screened by their general practitioner, and continues in the ordinary screening program | Behavioural | Control |
Primary outcome
Screening attendance rate (%)
Time frame: 6 months
The primary outcome measure is the attendance rate to cervical cancer screening. Attendance is defined as returning a self-sampling test, or being screened by a physician during the 6 months following receipt of the invitation letter
3 secondary outcomes
Prevalence of high-risk HPV (%)
Time frame: 6 months
Prevalence of CIN2+ (proportion of cervical intraepithelial neoplasia grade 2 or worse)
Time frame: 6 months
Compliance to clinical follow-up of a high-risk HPV positive screening test (%)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Derived from this study: PubMed 35995936Aasbo G, Trope A, Nygard M, Christiansen IK, Baasland I, Iversen GA, Munk AC, Christiansen MH, Presthus GK, Undem K, Bjorge T, Castle PE, Hansen BT. HPV self-sampling among long-term non-attenders to cervical cancer screening in Norway: a pragmatic randomised controlled trial. Br J Cancer. 2022 Nov;127(10):1816-1826. doi: 10.1038/s41416-022-01954-9. Epub 2022 Aug 23.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opt-in; Receive offer to order self-sampling kit and Opt-out; Receive self-sampling kit unsolicited in people with Cervical Cancer, run by Oslo University Hospital at 1 site 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 1 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: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Screening attendance rate (%) (time frame: 6 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 NCT03873376, 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 21 Apr 2022.