Cervical Intra-epithelial Neoplasia Grade 1 or WorseNCT02780960
Human Papillomavirus (HPV) Self-sampling as a Test of Cure After Treatment of Cervical Intra-epithelial Neoplasia
A study testing HPV self-testing in people with Cervical Intra-epithelial Neoplasia Grade 1 or Worse, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The purpose of this study is to evaluate the performance of HPV self-sampling (self-HPV) in detecting residual/recurrent disease in women treated by loop electro-surgical excision (LEEP) for CIN1+. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Intra-epithelial Neoplasia Grade 1 or Worse
- What is being tested?
- HPV self-testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2016to Oct 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- attending colposcopy clinic
- biopsy-proven CIN1+ lesion
- understands study procedures and accepts voluntarily to participate by signing the informed consent form
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HPV Self-sampling as a Test of Cure After Treatment of Cervical Intra-epithelial Neoplasia
The purpose of this study is to evaluate the performance of HPV self-sampling (self-HPV) in detecting residual/recurrent disease in women treated by loop electro-surgical excision (LEEP) for CIN1+.
Read the detailed description
The HPV test is an efficient method to assess the long-term risk of residual/recurrent disease in women treated for cervical intraepithelial neoplasia grade 1 or worse (CIN1+).
Women treated by LEEP for CIN1+ will be invited to participate. Follow-up visits will be performed at 6 months and 12 months after treatment and will include cytology, colposcopy when indicated and HPV testing. Two weeks before each follow-up visit at the colposcopy clinic, a home-based Self-HPV will be organized. A sample of 168 women will be included. Agreement between the two methods (Dr-HPV vs. S-HPV) will be measured using the kappa statistic (κ).
the investigators expect to find that Self-HPV may be an accurate method to predict residual and recurrent disease in women previously treated by LEEP.
- Being tested
- HPV self-testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV self-testingDevice
Patients will perform HPV testing themselves at home.
| Study group | Role | What they receive |
|---|---|---|
| HPV self-testing | Experimental | Patients will perform HPV self-testing at home, prior to their follow-up visit. At the colposcopy visit, the doctor or nurse will also perform HPV testing. This procedure will be repeated at 6 and 12 months following LEEP. Receives: Device: HPV self-testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with CIN
Number of patients with CIN after LEEP.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2020
- Study completionOct 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 Intra-epithelial Neoplasia Grade 1 or WorseStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuela Viviano, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780960
- Sponsor's protocol ID
- 15-285
- Status last verified
- Jan 2021
- First submitted
- 13 May 2016
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Viviano M, Vassilakos P, Meyer-Hamme U, Grangier L, Emery SL, Malinverno MU, Petignat P. HPV self-sampling in the follow-up of women after treatment of cervical intra-epithelial neoplasia: A prospective study in a high-income country. Prev Med Rep. 2021 Sep 20;24:101564. doi: 10.1016/j.pmedr.2021.101564. eCollection 2021 Dec.
PubMed 34976630
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Self-sampling as a Test of Cure After Treatment of Cervical Intra-epithelial Neoplasia
- ClinicalTrials.gov ID
- NCT02780960
- Acronym / sponsor ID
- 15-285
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Sep 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 24 May 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.
The purpose of this study is to evaluate the performance of HPV self-sampling (self-HPV) in detecting residual/recurrent disease in women treated by loop electro-surgical excision (LEEP) for CIN1+.
Detailed description
The HPV test is an efficient method to assess the long-term risk of residual/recurrent disease in women treated for cervical intraepithelial neoplasia grade 1 or worse (CIN1+).
Women treated by LEEP for CIN1+ will be invited to participate. Follow-up visits will be performed at 6 months and 12 months after treatment and will include cytology, colposcopy when indicated and HPV testing. Two weeks before each follow-up visit at the colposcopy clinic, a home-based Self-HPV will be organized. A sample of 168 women will be included. Agreement between the two methods (Dr-HPV vs. S-HPV) will be measured using the kappa statistic (κ).
the investigators expect to find that Self-HPV may be an accurate method to predict residual and recurrent disease in women previously treated by LEEP.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV self-testing | Experimental | Device: HPV self-testingPatients will perform HPV self-testing at home, prior to their follow-up visit. At the colposcopy visit, the doctor or nurse will also perform HPV testing. This procedure will be repeated at 6 and 12 months following LEEP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- attending colposcopy clinic
- biopsy-proven CIN1+ lesion
- understands study procedures and accepts voluntarily to participate by signing the informed consent form
Key exclusion criteria (1 listed)
- pregnancy
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 self-testingPatients will perform HPV testing themselves at home. | Device | HPV self-testing |
Primary outcome
Number of patients with CIN
Time frame: 12 months
Number of patients with CIN after LEEP.
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 3 Feb 2021.
- Derived from this study: PubMed 34976630Viviano M, Vassilakos P, Meyer-Hamme U, Grangier L, Emery SL, Malinverno MU, Petignat P. HPV self-sampling in the follow-up of women after treatment of cervical intra-epithelial neoplasia: A prospective study in a high-income country. Prev Med Rep. 2021 Sep 20;24:101564. doi: 10.1016/j.pmedr.2021.101564. eCollection 2021 Dec.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV self-testing in people with Cervical Intra-epithelial Neoplasia Grade 1 or Worse, run by University Hospital, Geneva at 1 site in Switzerland.
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 3 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 3 Feb 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 Switzerland. 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?
Number of patients with CIN (time frame: 12 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 NCT02780960, 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 3 Feb 2021.