Therapeutic Abstention and Surveillance of Intra-epithelial Histological Lesions of High Grade Cervical CIN2 (Cervical Intraepithelial Neoplasia Grade 2). SUIVICIN (SUIVICIN)

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

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer; HPV Infection
• Intervention / Treatment: Other: abstention from CIN2 treatment and surveillance for at least 2 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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jean-Luc Brun, MD, PhD; Phone Number: 335 56 79 59 85; Email: jean-luc.brun@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France
    • Recruiting
    • CHU Bordeaux
    • Contact: Jean-Luc Brun, MD, PhD; Phone Number: 335 56 79 59 85; Email: jean-luc.brun@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: abstention from CIN2 treatment and surveillance for at least 2 years; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	1, 2, 3 and 4 years
HPV viral expression	Binary criteria: yes / No	1, 2, 3 and 4 years

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2019
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: HPV; cervical cancer; alternative to surgery
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Infections; Virus Diseases; Uterine Diseases; Genital Diseases, Female; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Genital Neoplasms, Female; Precancerous Conditions; Uterine Cervical Diseases; Uterine Neoplasms; Tumor Virus Infections; Uterine Cervical Neoplasms; Papillomavirus Infections; Uterine Cervical Dysplasia
• Other Study ID Numbers: CHUBX 2019/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No