Cervix Uteri SILRECERNCT06147388
Regression of Cervical Precancerous Lesions and Associated Risk Factors
An observational study of Cervix Uteri SIL and HPV, run by General University Hospital, Prague at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cervix Uteri SIL, HPV, CIN2
- What is being tested?
- Colposcopy
- How many people
- 300 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2022to 1 Jul 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
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.
Who may be able to join
- squamocolumnar junction fully visualized
- bioptically verified CIN 2 or CIN 3
- age ≥ 18 years
- age ≤ 40 years
- informed consent
Who cannot join
- squamocolumnar junction not fully visualized
- suspicion on glandular lesion
- suspicion on invasive cancer
- personal history of CIN 2, 3 or cerv. cancer
- gravidity
- HIV positivity
- immunosuppression
- impossible photographic documentation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
General University Hospital
Prague, 12800
Lukas Dostalek, +420224967451, lukas.dostalek@vfn.cz
About this study
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.
Read the 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.
- Conditions
- Cervix Uteri SIL, HPV, CIN2, CIN3
- Being tested
- Colposcopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColposcopyDiagnostic test
No surgery, observation
| Study group | Role | What they receive |
|---|---|---|
| CIN 2, CIN 3 | Bioptically verified CIN 2 or CIN 3 lesion Receives: Diagnostic Test: Colposcopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (4)
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.
Measured: 3 years
Rate of cytological normalization in patients with spontaneous regression compared to patients with persistence after conization
Measured: 3 years
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
Measured: 3 years
Development of a model for predicting spontaneous regression
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start1 Sep 2022
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervix Uteri SILStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Cibula, General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147388
- Sponsor's protocol ID
- 154/22 S
- Acronym
- RECER
- Status last verified
- Feb 2026
- First submitted
- 15 Nov 2023
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dostalek L, Brynda D, Marek R, Hederlingova J, Tripac I, Nemejcova K, Slovackova M, Zima T, Cibula D, Slama J. Regression of high-grade squamous intraepithelial cervical lesions and associated risk factors (RECER). Int J Gynecol Cancer. 2025 May;35(5):101768. doi: 10.1016/j.ijgc.2025.101768. Epub 2025 Mar 13.
PubMed 40215795
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regression of Cervical Precancerous Lesions and Associated Risk Factors
- ClinicalTrials.gov ID
- NCT06147388
- Acronym / sponsor ID
- RECER / 154/22 S
- Conditions
- Cervix Uteri SIL, HPV, CIN2, CIN3
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 27 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CIN 2, CIN 3 | – | Diagnostic Test: ColposcopyBioptically verified CIN 2 or CIN 3 lesion |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- squamocolumnar junction fully visualized
- bioptically verified CIN 2 or CIN 3
- age ≥ 18 years
- age ≤ 40 years
- informed consent
Key exclusion criteria (8 listed)
- squamocolumnar junction not fully visualized
- suspicion on glandular lesion
- suspicion on invasive cancer
- personal history of CIN 2, 3 or cerv. cancer
- gravidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColposcopyNo surgery, observation | Diagnostic test | CIN 2, CIN 3 |
Primary outcome
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.
4 secondary outcomes
Rate of HPV negativization in patients with spontaneous regression compared to patients with persistence after conization
Time frame: 3 years
Rate of cytological normalization in patients with spontaneous regression compared to patients with persistence after conization
Time frame: 3 years
Regression-rate considering specified stratification factors
Time frame: 3 years
Development of a model for predicting spontaneous regression
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Derived from this study: PubMed 40215795Dostalek L, Brynda D, Marek R, Hederlingova J, Tripac I, Nemejcova K, Slovackova M, Zima T, Cibula D, Slama J. Regression of high-grade squamous intraepithelial cervical lesions and associated risk factors (RECER). Int J Gynecol Cancer. 2025 May;35(5):101768. doi: 10.1016/j.ijgc.2025.101768. Epub 2025 Mar 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervix Uteri SIL and HPV, run by General University Hospital, Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lukas Dostalek (+420224967451, lukas.dostalek@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06147388, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.