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Regression of Cervical Precancerous Lesions and Associated Risk Factors

NCT ID: NCT06147388

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2027-09-01

Brief Summary

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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

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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

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Cervix Uteri SIL HPV CIN2 CIN3

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CIN 2, CIN 3

Bioptically verified CIN 2 or CIN 3 lesion

Colposcopy

Intervention Type DIAGNOSTIC_TEST

No surgery, observation

Interventions

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Colposcopy

No surgery, observation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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General University Hospital, Prague

OTHER

Sponsor Role lead

Responsible Party

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David Cibula

Dr, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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General University Hospital

Prague, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Lukas Dostalek

Role: CONTACT

[email protected]
+420224967451

Facility Contacts

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Lukas Dostalek

Role: primary

[email protected]
+420224967451

References

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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.

Reference Type DERIVED
PMID: 40215795 (View on PubMed)

Other Identifiers

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154/22 S

Identifier Type: -

Identifier Source: org_study_id