HPV InfectionSUIVICINNCT04057924
Therapeutic Abstention and Surveillance of Intra-epithelial Histological Lesions of High Grade Cervical CIN2 (Cervical Intraepithelial Neoplasia Grade 2). SUIVICIN
An observational study of HPV Infection and Cervical Cancer, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
This study proposes to describe and evaluate the rate of spontaneous regression of CIN2 at 2 year of follow up in women between 18 and 39 year old. This follow-up is proposed as an alternative to the treatment of reference (conization) with a possible extension to 4 years Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HPV Infection, Cervical Cancer
- What is being tested?
- abstention from CIN2 treatment and surveillance for at least 2 years
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 23 Aug 2019to 1 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: women with a CIN2 meeting the eligibility criteria will benefit from abstention from treatment and surveillance for at least 2 years
Who may be able to join
- CIN2 confirmed by biopsy, age between 18 and 39 years,
- satisfactory colposcopy identifying the junction and the lesion,
- affiliated person or beneficiary of a social security scheme,
- having given their oral agreement and authorization to the processing of their data.
Who cannot join
- Pregnancy in progress,
- history of conization,
- atypical or atypical glandular cells or cancer incidentally discovered during smear,
- prophylactic vaccination against HPV,
- active systemic infection requiring treatment, history of HIV infection, congenital or acquired immunodepression,
- long-term treatment with corticosteroids or immunosuppressants, placement under safeguard of justice,
- non-compliance with protocol requirements, in particular a supposed lack of compliance with long-term follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Bordeaux
Bordeaux
Jean-Luc Brun, MD, PhD, 335 56 79 59 85, jean-luc.brun@chu-bordeaux.fr
About this study
This study proposes to describe and evaluate the rate of spontaneous regression of CIN2 at 2 year of follow up in women between 18 and 39 year old. This follow-up is proposed as an alternative to the treatment of reference (conization) with a possible extension to 4 years
Read the detailed description
The INCa recommendations of December 2016 propose the destruction or abstention-monitoring of high-grade histological cervical lesions (HSIL) as an alternative to conization under certain conditions. These are women under 30 years old, with a small lesion in colposcopy, without any sign of invasion, with a squamocolumnar junction seen. These women must accept the principle of regular monitoring by cytology and colposcopy +/- biopsy every 6 months for a maximum of 2 years. HSIL group 2 histological entities CIN2 and CIN3. It is recognized that CIN2 are associated with CIN1 and CIN3 biology whose diagnosis is the result of the subjectivity of colposcopy allowing cervical biopsy and the variability of pathological interpretation due to poor reproducibility of histological diagnosis. CIN2 regress spontaneously in more than 50% of cases at 1 year, either completely (no lesion) or partially (LSIL low grade lesions). No invasive lesions are diagnosed over 2-year observation periods. Among the clinical, pathological and virological criteria, only the initial HPV genotyping seems to have a prognostic influence. There is therefore no strong scientific argument for routine conization in a woman over 30 years of age with a CIN2 lesion extended over more than two quadrants. In addition, conization is associated with an obstetrical risk (prematurity) and post-therapeutic colposcopic cervical stenosis complicates subsequent monitoring in case of abnormal smears. These considerations encourage the extension of the indications of abstention monitoring in the management of women with CIN2 wishing to procreate with an extension of the age to 39 year old, with no limit of size of the lesion and to satisfactory colposcopy
- Conditions
- HPV Infection, Cervical Cancer
- Being tested
- abstention from CIN2 treatment and surveillance for at least 2 years
- Keywords
- HPV, alternative to surgery, cervical cancer
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abstention from CIN2 treatment and surveillance for at least 2 yearsOther
Non-interventional monocentric prospective study taking place at the Bordeaux University Hospital where women with a CIN2 meeting the eligibility criteria will benefit from abstention from treatment and surveillance for at least 2 years
| Study group | Role | What they receive |
|---|---|---|
| CIN 2 women | Non-interventional monocentric prospective study taking place at the Bordeaux University Hospital where women with a CIN2 meeting the eligibility criteria will benefit from abstention from treatment and surveillance for at least 2 years Receives: Other: abstention from CIN2 treatment and surveillance for at least 2 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of spontaneous regression of CIN2 at 2 years
Rate of spontaneous regression of CIN2 at 2 years, either complete (disappearance of the lesion) or partial (<lesions of low grade LSIL).
Measured: 2 years
Secondary outcomes (3)
rate of regression of CIN2 at 4 years
rate of regression of CIN2 at 4 years in women who responded to the main rate of regression of CIN2 at 4 years in women who responded to the main objective (disappearance of the lesion or lesions <low grade LSIL) and monitored for 2 more years
Measured: 4 years
4-year regression rate of CIN2 that persisted for 2 years
evaluate the 4-year regression rate of CIN2 that persisted for 2 years in women who had not been treated with conization
Measured: 1, 2, 3 and 4 years
HPV viral expression
Binary criteria: yes / No
Measured: 1, 2, 3 and 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start23 Aug 2019
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057924
- Sponsor's protocol ID
- CHUBX 2019/03
- Acronym
- SUIVICIN
- Status last verified
- Feb 2025
- First submitted
- 4 Jul 2019
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Abstention and Surveillance of Intra-epithelial Histological Lesions of High Grade Cervical CIN2 (Cervical Intraepithelial Neoplasia Grade 2). SUIVICIN
- ClinicalTrials.gov ID
- NCT04057924
- Acronym / sponsor ID
- SUIVICIN / CHUBX 2019/03
- Conditions
- HPV Infection, Cervical Cancer
- Keywords
- HPV, alternative to surgery, cervical cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 15 Aug 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.
This study proposes to describe and evaluate the rate of spontaneous regression of CIN2 at 2 year of follow up in women between 18 and 39 year old. This follow-up is proposed as an alternative to the treatment of reference (conization) with a possible extension to 4 years
Detailed description
The INCa recommendations of December 2016 propose the destruction or abstention-monitoring of high-grade histological cervical lesions (HSIL) as an alternative to conization under certain conditions. These are women under 30 years old, with a small lesion in colposcopy, without any sign of invasion, with a squamocolumnar junction seen. These women must accept the principle of regular monitoring by cytology and colposcopy +/- biopsy every 6 months for a maximum of 2 years. HSIL group 2 histological entities CIN2 and CIN3. It is recognized that CIN2 are associated with CIN1 and CIN3 biology whose diagnosis is the result of the subjectivity of colposcopy allowing cervical biopsy and the variability of pathological interpretation due to poor reproducibility of histological diagnosis. CIN2 regress spontaneously in more than 50% of cases at 1 year, either completely (no lesion) or partially (LSIL low grade lesions). No invasive lesions are diagnosed over 2-year observation periods. Among the clinical, pathological and virological criteria, only the initial HPV genotyping seems to have a prognostic influence. There is therefore no strong scientific argument for routine conization in a woman over 30 years of age with a CIN2 lesion extended over more than two quadrants. In addition, conization is associated with an obstetrical risk (prematurity) and post-therapeutic colposcopic cervical stenosis complicates subsequent monitoring in case of abnormal smears. These considerations encourage the extension of the indications of abstention monitoring in the management of women with CIN2 wishing to procreate with an extension of the age to 39 year old, with no limit of size of the lesion and to satisfactory colposcopy
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CIN 2 women | – | Other: abstention from CIN2 treatment and surveillance for at least 2 yearsNon-interventional monocentric prospective study taking place at the Bordeaux University Hospital where women with a CIN2 meeting the eligibility criteria will benefit from abstention from treatment and surveillance for at least 2 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with a CIN2 meeting the eligibility criteria will benefit from abstention from treatment and surveillance for at least 2 years
Key inclusion criteria (4 listed)
- CIN2 confirmed by biopsy, age between 18 and 39 years,
- satisfactory colposcopy identifying the junction and the lesion,
- affiliated person or beneficiary of a social security scheme,
- having given their oral agreement and authorization to the processing of their data.
Key exclusion criteria (7 listed)
- Pregnancy in progress,
- history of conization,
- atypical or atypical glandular cells or cancer incidentally discovered during smear,
- prophylactic vaccination against HPV,
- active systemic infection requiring treatment, history of HIV infection, congenital or acquired immunodepression,
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 |
|---|---|---|
| abstention from CIN2 treatment and surveillance for at least 2 yearsNon-interventional monocentric prospective study taking place at the Bordeaux University Hospital where women with a CIN2 meeting the eligibility criteria will benefit from abstention from treatment and surveillance for at least 2 years | Other | CIN 2 women |
Primary outcome
rate of spontaneous regression of CIN2 at 2 years
Time frame: 2 years
Rate of spontaneous regression of CIN2 at 2 years, either complete (disappearance of the lesion) or partial (<lesions of low grade LSIL).
3 secondary outcomes
rate of regression of CIN2 at 4 years
Time frame: 4 years
4-year regression rate of CIN2 that persisted for 2 years
Time frame: 1, 2, 3 and 4 years
HPV viral expression
Time frame: 1, 2, 3 and 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- 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.
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 Infection and Cervical Cancer, run by University Hospital, Bordeaux at 1 site in France.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 10 Feb 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Luc Brun, MD, PhD (335 56 79 59 85, jean-luc.brun@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of spontaneous regression of CIN2 at 2 years (time frame: 2 years). 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 10 Feb 2025.