Regression of Cervical Precancerous Lesions and Associated Risk Factors

NCT06147388 | Recruiting

• 1 other identifier: 154/22 S
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervix Uteri SIL; HPV; CIN2; CIN3

Outcome Measures

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.

  3 years

Secondary Outcomes (4)

• Rate of HPV negativization in patients with spontaneous regression compared to patients with persistence after conization

  3 years

• Rate of cytological normalization in patients with spontaneous regression compared to patients with persistence after conization

  3 years

• Regression-rate considering specified stratification factors

  3 years

• Development of a model for predicting spontaneous regression

  3 years

Study Arms (1)

CIN 2, CIN 3

Bioptically verified CIN 2 or CIN 3 lesion

Diagnostic Test: Colposcopy

Interventions

Colposcopy DIAGNOSTIC_TEST

No surgery, observation

CIN 2, CIN 3

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• squamocolumnar junction fully visualized
• bioptically verified CIN 2 or CIN 3
• age ≥ 18 years
• age ≤ 40 years
• informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• General University Hospital, Prague: lead

Study Sites (1)

General University Hospital

Prague, 12800, Czechia

RECRUITING

Related Publications (1)

• 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.

  PMID: 40215795 DERIVED

MeSH Terms

Interventions

Colposcopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Central Study Contacts

Lukas Dostalek

CONTACT

+420224967451; lukas.dostalek@vfn.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, PhD

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 27, 2023
• Study Start: September 1, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

CZ (1)