HPVNCT04909281
Feasibility of Sending a Direct Send HPV Self-sampling Kit to Long-term Screening Non-attenders
An observational study of HPV and Cervical Cancer, run by Falu Hospital at 1 site in Sweden.
Trial summary
All women in one Swedish county who had not participated in the organized screening program for at least 10 years were sent an HPV self-sampling kit. Women who were positive for HPV were referred to a gynecological examination including colposcopy and further testing according to national guidelines. Read more about this study
- Who is it for?
- Ages 33 to 70 years, women only
- Conditions the study is for
- HPV, Cervical Cancer
- What is being tested?
- Self-sampling HPV
- How many people
- 741 participants
- Where
- 1 siteSweden
- Study dates
- 28 Aug 2019to 4 Apr 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 33 to 70 years
- Women only
- Adult, Older adult
Study population: Women who had not participated in the organized screening program for at least 10 years in 1 Swedish county
Who may be able to join
- Women who had not participated in the organized screening program for at least 10 years
Who cannot join
- Women who were hystrectomized, moved, died
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Sending a Direct Send HPV Self-sampling Kit to Long-term Non-attenders in an Organized Cervical Screening Program
All women in one Swedish county who had not participated in the organized screening program for at least 10 years were sent an HPV self-sampling kit. Women who were positive for HPV were referred to a gynecological examination including colposcopy and further testing according to national guidelines.
Read the detailed description
In this cohort study nested in the organized cervical screening program, all women who had not participated in the organized screening program for at least 10 years in one Swedish county were eligible. Women were identified through the screening hub register that administrates for all invitations, referrals, and monitoring of the cervical screening program. The county screening hub invites approximately 30 000 women yearly to routine screening. Those who had opted out of the screening program, undergone hysterectomy, or changed their personal identification number (PNR) were excluded. HPV self-sampling kits with instructions and invitation letters were sent from the Department of Laboratory Medicine, Falun Hospital, in batches over 4 weeks. Lists of invitees were checked against changes in the screening hub register for individuals who moved, emigrated, died, or had taken a routine screening sample before sending a kit. Samples were received and HPV-analysis was performed.
If the self-sample HPV test was negative, the woman was returned to the screening program according to routine practice. HPV-positive women were referred without triage for further investigation to a gynecologist responsible for the clinical follow-up of high-risk women. The gynecological examination included colposcopy as well as biopsies and a liquid based cytology (LBC) sample (analyzed for cytology and HPV), which are routine examinations in clinical practice according to national and international guidelines. Colposcopies were performed within 3 months of a positive self-sample. If the colposcopic examination or the cytological/histopathological results indicated high-grade squamous intraepithelial lesions (HSIL) or invasive cervical cancer, women underwent treatment by conization and/or hysterectomy according to national guidelines The Cobas® PCR Female Swab Sample Packet was used for self-sampling, as previous studies had determined that the sensitivity for HPV was high and comparable with cervical samples used in the organized screening program. The HPV analysis was performed at the Department of Laboratory Medicine, Falun Hospital using the Cobas 4800 HPV Test (Roche Molecular Systems, South Branchburg, New Jersey, USA).
- Conditions
- HPV, Cervical Cancer
- Being tested
- Self-sampling HPV
- Keywords
- self sampling
- 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.
Self-sampling HPVDiagnostic test
In this cohort study nested in the organized cervical screening program, all women who had not participated in the organized screening program for at least 10 years in one Swedish county were eligible.
| Study group | Role | What they receive |
|---|---|---|
| Long-term non-attenders in the cervical screening program | All women who had not attended tthe cervical screening program in Sweden for at least 10 years were eligeble. Receives: Diagnostic Test: Self-sampling HPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathologically confirmed high grade cervical lesions and cervical cancer among long-trem non-attenders in the organized cervical screening program
To evaluate the prevalence of high grade cervical lesions and cervical cancer cancer among long-term non-attenders in the organized screening program
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start28 Aug 2019
- Primary completion3 Sep 2019
- Study completion4 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPVStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 741 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Falu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanna Sahlgren, Falu Hospital
- Investigators
- Hanna I Sahlgren, md, Principal investigator, RCCMiriam K Elfström, phd, Principal investigator, RCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909281
- Sponsor's protocol ID
- DNR 2019-02564
- Status last verified
- May 2021
- First submitted
- 27 May 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share upon demand
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Sending a Direct Send HPV Self-sampling Kit to Long-term Non-attenders in an Organized Cervical Screening Program
- ClinicalTrials.gov ID
- NCT04909281
- Acronym / sponsor ID
- DNR 2019-02564
- Conditions
- HPV, Cervical Cancer
- Keywords
- self sampling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 741 participants (actual)
- Lead sponsor
- Falu HospitalUniversity, hospital or other
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 3 Sep 2019 (actual)
- Study completion
- 4 Apr 2020 (actual)
- First posted
- 1 Jun 2021 (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.
All women in one Swedish county who had not participated in the organized screening program for at least 10 years were sent an HPV self-sampling kit. Women who were positive for HPV were referred to a gynecological examination including colposcopy and further testing according to national guidelines.
Detailed description
In this cohort study nested in the organized cervical screening program, all women who had not participated in the organized screening program for at least 10 years in one Swedish county were eligible. Women were identified through the screening hub register that administrates for all invitations, referrals, and monitoring of the cervical screening program. The county screening hub invites approximately 30 000 women yearly to routine screening. Those who had opted out of the screening program, undergone hysterectomy, or changed their personal identification number (PNR) were excluded. HPV self-sampling kits with instructions and invitation letters were sent from the Department of Laboratory Medicine, Falun Hospital, in batches over 4 weeks. Lists of invitees were checked against changes in the screening hub register for individuals who moved, emigrated, died, or had taken a routine screening sample before sending a kit. Samples were received and HPV-analysis was performed.
If the self-sample HPV test was negative, the woman was returned to the screening program according to routine practice. HPV-positive women were referred without triage for further investigation to a gynecologist responsible for the clinical follow-up of high-risk women. The gynecological examination included colposcopy as well as biopsies and a liquid based cytology (LBC) sample (analyzed for cytology and HPV), which are routine examinations in clinical practice according to national and international guidelines. Colposcopies were performed within 3 months of a positive self-sample. If the colposcopic examination or the cytological/histopathological results indicated high-grade squamous intraepithelial lesions (HSIL) or invasive cervical cancer, women underwent treatment by conization and/or hysterectomy according to national guidelines The Cobas® PCR Female Swab Sample Packet was used for self-sampling, as previous studies had determined that the sensitivity for HPV was high and comparable with cervical samples used in the organized screening program. The HPV analysis was performed at the Department of Laboratory Medicine, Falun Hospital using the Cobas 4800 HPV Test (Roche Molecular Systems, South Branchburg, New Jersey, USA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long-term non-attenders in the cervical screening program | – | Diagnostic Test: Self-sampling HPVAll women who had not attended tthe cervical screening program in Sweden for at least 10 years were eligeble. |
Who may qualify
- Ages
- 33 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women who had not participated in the organized screening program for at least 10 years in 1 Swedish county
Key inclusion criteria (1 listed)
- Women who had not participated in the organized screening program for at least 10 years
Key exclusion criteria (1 listed)
- Women who were hystrectomized, moved, died
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 |
|---|---|---|
| Self-sampling HPVIn this cohort study nested in the organized cervical screening program, all women who had not participated in the organized screening program for at least 10 years in one Swedish county were eligible. | Diagnostic test | Long-term non-attenders in the cervical screening program |
Primary outcome
Histopathologically confirmed high grade cervical lesions and cervical cancer among long-trem non-attenders in the organized cervical screening program
Time frame: 1 year
To evaluate the prevalence of high grade cervical lesions and cervical cancer cancer among long-term non-attenders in the organized screening program
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 1 Jun 2021.
- Individual participant dataSharing planned: Yes. Share upon demand
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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.
Hanna I Sahlgren, md principal investigator
RCC
Miriam K Elfström, phd principal investigator
RCC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV and Cervical Cancer, run by Falu Hospital at 1 site in Sweden.
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 1 Jun 2021. 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 Sweden. 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?
Histopathologically confirmed high grade cervical lesions and cervical cancer among long-trem non-attenders in the organized cervical screening program (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2021.