Cancer of the Uterine CervixDEPISTNCT02698423
Feasibility and Acceptability of Offering Self-sampling to Non-attendees in Primary Care
A study testing Cobas HPV DNA Test and Papanicolau test in people with Cancer of the Uterine Cervix, run by University Hospital, Geneva.
Trial summary
The purpose of this study is to determine whether human-papillomavirus (HPV) self-sampling can be used as a primary screening test for unscreened women. Read more about this study
- Who is it for?
- Ages 25 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer of the Uterine Cervix
- What is being tested?
- Cobas HPV DNA Test and Papanicolau test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 667 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No previous cervical cancer screening test in the last three years
Who cannot join
- pregnancy
- previous hysterectomy
About this study
Official title: Human Papillomavirus Testing Versus Liquid-based Cytology for Non-attendees of Cervical Cancer Screening: Results of a Randomised Controlled Trial
The purpose of this study is to determine whether human-papillomavirus (HPV) self-sampling can be used as a primary screening test for unscreened women.
Read the detailed description
Women residing in the canton of Geneva, aged between 25 and 69 years, who haven't had a Pap test in the last three years, will be invited to participate. Participation to the study will be encouraged through public displays, social networks, and medical consultations. Women meeting the eligibility criteria will be enrolled in the study. They will be randomized into two groups and will receive a home-sent letter, inviting them to either come in for a Pap test or to perform and send back the HPV self-sample that they'll receive at their domicile. Both groups will also receive a questionnaire, in order to better understand the reasons for their previous non-attendance to cervical cancer screening.
- Conditions
- Cancer of the Uterine Cervix
- Being tested
- Cobas HPV DNA Test, Papanicolau test
- 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.
Cobas HPV DNA TestDevice
Women will receive a home-sent sample for HPV self-testing
Papanicolau testOther
Women will be invited to come in for a physician-performed Pap test
| Study group | Role | What they receive |
|---|---|---|
| Cobas HPV DNA test | Experimental | Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home. Receives: Device: Cobas HPV DNA Test |
| Papanicolau test | Active comparator | Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician. Receives: Other: Papanicolau test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Performed HPV Self-testing Compared to the Number of Participants Who Responded to the Invitation to Come to the Hospital for Pap Testing
Compare the participation rate to cervical cancer screening for home-based human papillomavirus testing based on self-sampling versus clinic-based, physician-performed Pap testing.
Measured: 1 year
Secondary outcomes (1)
Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations.
Assess the compliance with further follow-up among women having tested positive for the presence of HPV at baseline screening.
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 posted3 Mar 2016 (estimated)
- Study startSep 2011
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer of the Uterine CervixStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Patrick Petignat, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698423
- Sponsor's protocol ID
- CER 11-034
- Acronym
- DEPIST
- Status last verified
- May 2018
- First submitted
- 23 Feb 2016
- Last updated
- 6 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be used for scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Papillomavirus Testing Versus Liquid-based Cytology for Non-attendees of Cervical Cancer Screening: Results of a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02698423
- Acronym / sponsor ID
- DEPIST / CER 11-034
- Conditions
- Cancer of the Uterine Cervix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Posted 2 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether human-papillomavirus (HPV) self-sampling can be used as a primary screening test for unscreened women.
Detailed description
Women residing in the canton of Geneva, aged between 25 and 69 years, who haven't had a Pap test in the last three years, will be invited to participate. Participation to the study will be encouraged through public displays, social networks, and medical consultations. Women meeting the eligibility criteria will be enrolled in the study. They will be randomized into two groups and will receive a home-sent letter, inviting them to either come in for a Pap test or to perform and send back the HPV self-sample that they'll receive at their domicile. Both groups will also receive a questionnaire, in order to better understand the reasons for their previous non-attendance to cervical cancer screening.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cobas HPV DNA test | Experimental | Device: Cobas HPV DNA TestWomen will be invited to perform HPV self-testing with the Cobas HPV DNA test at home. |
| Papanicolau test | Active comparator | Other: Papanicolau testWomen will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician. |
Who may qualify
- Ages
- 25 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- No previous cervical cancer screening test in the last three years
Key exclusion criteria (2 listed)
- pregnancy
- previous hysterectomy
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 |
|---|---|---|
| Cobas HPV DNA TestWomen will receive a home-sent sample for HPV self-testing | Device | Cobas HPV DNA test |
| Papanicolau testWomen will be invited to come in for a physician-performed Pap test | Other | Papanicolau test |
Primary outcome
Number of Participants Who Performed HPV Self-testing Compared to the Number of Participants Who Responded to the Invitation to Come to the Hospital for Pap Testing
Time frame: 1 year
Compare the participation rate to cervical cancer screening for home-based human papillomavirus testing based on self-sampling versus clinic-based, physician-performed Pap testing.
1 secondary outcome
Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations.
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be used for scientific publications.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cobas HPV DNA Test and Papanicolau test in people with Cancer of the Uterine Cervix, run by University Hospital, Geneva.
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 2 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 2 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Performed HPV Self-testing Compared to the Number of Participants Who Responded to the Invitation to Come to the Hospital for Pap Testing (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 6 Jun 2018.