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Trial Title:
Regression of Cervical Precancerous Lesions and Associated Risk Factors
NCT ID:
NCT06147388
Condition:
Cervix Uteri SIL
HPV
CIN2
CIN3
Conditions: Official terms:
Squamous Intraepithelial Lesions of the Cervix
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Colposcopy
Description:
No surgery, observation
Arm group label:
CIN 2, CIN 3
Summary:
The aim of this study is to assess the extent of histopathological regression of severe
cervical precancerous lesions (CIN 2 and CIN 3); evaluate the proportion of patients who
experience the normalization of HPV test and cytology finding among those who were
treated conservatively and those who underwent conization; and identify predictive
parameters associated with regression. Based on this analysis, a model will be proposed
to predict the likelihood of lesion regression.
Detailed description:
Introduction There are three grades of dysplasia of the cervix based on their severity
(CIN 1-3). Most women with CIN 2 or CIN 3 (high-grade - HG lesions) are referred for
conization due to the presumed risk of developing invasive cervical cancer. However, this
surgical intervention is associated with an increased risk of preterm labor in the
future.
From the literature, it is evident that 30% - 60% of CIN 2 and CIN 3 lesions
spontaneously regress. Colposcopic examination is a tool that can accurately assess the
severity of the lesion and safely evaluate the dynamics of its development. It can be
used to exclude the presence of invasive cervical cancer.
The aim of the study is to determine the absolute rate of spontaneous regression of HG
lesions, considering stratification factors.
Methods Patients meeting all inclusion criteria and none of the exclusion criteria are
included (see below). Colposcopic evaluations occur at four-month intervals during the
study. In case of progression, the patient is indicated for conization; in case of
persistence, the patient is consulted and can choose further observation or conization;
in case of regression, punch biopsy is performed to acquire a histopathologic sample for
primary endpoint evaluation. The biopsy/conization result is subsequently compared with
the initial sample to declare regression or persistence of the HG lesion.
The HPV status and cytological findings are evaluated similarly. Stratification criteria
such as age, colposcopic characteristics, HPV genotype (Cobas 4800, Roche Molecular
Systems, Pleasanton, USA), methylation markers (GynTect®, Oncgnostics GmbH, Löbstedter
Str. 41, 07749 Jena, Germany), semiquantitative microscopic assessment of the vaginal
swab, and personal history are assessed during monitoring.
Criteria for eligibility:
Study pop:
Consecutive participant sampling of patients with bioptically-verified CIN 2 or CIN 3 and
fully visualised squamocolumnar junction with no suspiction on invasive cancer or
glandular lesion.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. squamocolumnar junction fully visualized
2. bioptically verified CIN 2 or CIN 3
3. age ≥ 18 years
4. age ≤ 40 years
5. informed consent
Exclusion Criteria:
1. squamocolumnar junction not fully visualized
2. suspicion on glandular lesion
3. suspicion on invasive cancer
4. personal history of CIN 2, 3 or cerv. cancer
5. gravidity
6. HIV positivity
7. immunosuppression
8. impossible photographic documentation
Gender:
Female
Minimum age:
18 Years
Maximum age:
40 Years
Locations:
Facility:
Name:
General University Hospital
Address:
City:
Prague
Zip:
12800
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Lukas Dostalek
Phone:
+420224967451
Email:
lukas.dostalek@vfn.cz
Start date:
September 1, 2022
Completion date:
September 1, 2027
Lead sponsor:
Agency:
General University Hospital, Prague
Agency class:
Other
Source:
General University Hospital, Prague
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06147388
