Clinical trial NCT04057924: Therapeutic Abstention and Surveillance of Intra-epithelial Histological Lesions of High Grade Cervical CIN2 (Cervical Intraepithelial Neoplasia Grade 2). SUIVICIN
Official title: Therapeutic Abstention and Surveillance of Intra-epithelial Histological Lesions of High Grade Cervical CIN2 (Cervical Intraepithelial Neoplasia Grade 2). SUIVICIN
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HPV Infection
Cervical Cancer
Keywords: HPV
alternative to surgery
cervical cancer
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with a CIN2 meeting the eligibility criteria will benefit from abstention from treatment and surveillance for at least 2 years

Brief 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

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: rate of spontaneous regression of CIN2 at 2 years
timeFrame: 2 years
Secondary outcomes:
measure: rate of regression of CIN2 at 4 years
timeFrame: 4 years
measure: 4-year regression rate of CIN2 that persisted for 2 years
timeFrame: 1, 2, 3 and 4 years
measure: HPV viral expression
timeFrame: 1, 2, 3 and 4 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References: