Therapeutic Abstention and Surveillance of Intra-epithelial Histological Lesions of High Grade Cervical CIN2 (Cervical Intraepithelial Neoplasia Grade 2). SUIVICIN
SUIVICIN
1 other identifier
observational
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2019
CompletedFirst Posted
Study publicly available on registry
August 15, 2019
CompletedStudy Start
First participant enrolled
August 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2029
February 10, 2025
February 1, 2025
10 years
July 4, 2019
February 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
rate of regression of CIN2 at 4 years
4 years
4-year regression rate of CIN2 that persisted for 2 years
1, 2, 3 and 4 years
HPV viral expression
1, 2, 3 and 4 years
Study Arms (1)
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
Interventions
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
Eligibility Criteria
women with a CIN2 meeting the eligibility criteria will benefit from abstention from treatment and surveillance for at least 2 years
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Bordeaux
Bordeaux, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2019
First Posted
August 15, 2019
Study Start
August 23, 2019
Primary Completion (Estimated)
September 1, 2029
Study Completion (Estimated)
September 1, 2029
Last Updated
February 10, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share