Regression of Cervical Precancerous Lesions and Associated Risk Factors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorGeneral University Hospital, Prague
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
squamocolumnar junction fully visualized
bioptically verified CIN 2 or CIN 3
age ≥ 18 years
age ≤ 40 years
Disqualifiers
squamocolumnar junction not fully visualized
suspicion on glandular lesion
suspicion on invasive cancer
personal history of CIN 2, 3 or cerv. cancer
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Colposcopy
Diagnostic testNo surgery, observation
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: CIN 2, CIN 31 intervention
Trial outcomes
Primary outcomes
1
Regression-rate of severe cervical precancerous lesions (CIN 2 and CIN 3) expressed through a comparison of initial and final histology
Histological results from the initial visit will be compared with the biopsy obtained during the last visit (or the specimen from conization) to determine whether regression or persistence of the high-grade lesion has occurred.
Time frame
3 yearsSecondary outcomes
1
Rate of HPV negativization in patients with spontaneous regression compared to patients with persistence after conization
The proportion of patients with a negative result on the HPV DNA test obtained during the final visit will be assessed.
Time frame
3 years2
Rate of cytological normalization in patients with spontaneous regression compared to patients with persistence after conization
Time frame
3 years3
Regression-rate considering specified stratification factors
Specific factors will be evaluated to determine their influence on the regression or persistence of the cervical high-grade lesion. The following factors will be assessed: * CIN Grade (CIN 2 / CIN 3) * Immunohistochemically detected biomarkers * p16INK4a * Ki-67 * E4 * Gene methylation (ASTN1, DLX1, ITGA4, RXFP3, SOX17, and ZNF671) * Histologically described cervicitis * Colposcopic Markers * Microbiological Markers * Selective HPV genotyping * Viral load * Anamnestic Data * Smoking * Age
Time frame
3 years4
Development of a model for predicting spontaneous regression
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov