Regression of Cervical Precancerous Lesions and Associated Risk Factors (RECER)

February 22, 2026 updated by: David Cibula, General University Hospital, Prague
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Czechia
      • Prague, Czechia, 12800
        • Recruiting
        • General University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
CIN 2, CIN 3
Bioptically verified CIN 2 or CIN 3 lesion
Diagnostic test: Colposcopy
No surgery, observation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Regression-rate of severe cervical precancerous lesions (CIN 2 and CIN 3) expressed through a comparison of initial and final histology
Time Frame: 3 years
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.
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of HPV negativization in patients with spontaneous regression compared to patients with persistence after conization
Time Frame: 3 years
The proportion of patients with a negative result on the HPV DNA test obtained during the final visit will be assessed.
3 years
Rate of cytological normalization in patients with spontaneous regression compared to patients with persistence after conization
Time Frame: 3 years
3 years
Regression-rate considering specified stratification factors
Time Frame: 3 years

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
3 years
Development of a model for predicting spontaneous regression
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
General University Hospital, Prague

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 154/22 S

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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