An observational study in HPV Infection and Cervical Cancer, sponsored by University Hospital, Bordeaux. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by University Hospital, Bordeaux · Observational
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
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
495 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.
This study's planned enrollment of 200 is below the median of 400 across 147 observational studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
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women with a CIN2 meeting the eligibility criteria will benefit from abstention from treatment and surveillance for at least 2 years
Exclusion Criteria:
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
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).
Time frame: 2 years
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
Time frame: 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
Time frame: 1, 2, 3 and 4 years
HPV viral expression
Binary criteria: yes / No
Time frame: 1, 2, 3 and 4 years
Plan to share: No
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University Hospital, Bordeaux