Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs

NCT06967740 | Recruiting

• 1 other identifier: EKVP/51/2024
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to develop a recommended clinical practice guideline for managing women with HPV HR (high-risk human papillomavirus) positivity and cervical lesions. Additionally, in collaboration with the Bioptic Laboratory, the study will analyze the integration of HPV HR testing into screening programs for women aged 35, 45, and 55, with a focus on optimizing management strategies for HPV HR-positive women. Research Objectives:

• Evaluate spontaneous regression/progression over two years based on HPV HR genotyping (three groups - according to Alinity: high, intermediate, and low risk).
• Assess spontaneous regression/progression over two years based on HPV HR genotyping and viral load in HPV-vaccinated vs. non-vaccinated patients.
• Evaluate spontaneous regression/progression over two years based on methylation results.
• Assess spontaneous regression/progression over two years based on CinTec plus results.

Conditions

Cervical Cancer; Cervical Intraepithelial Neoplasia (CIN); Risk Factors; Conservative Management

Keywords

Cervical Intraepithelial Neoplasia (CIN); Conservative management; Precancerous cervical lesions

Outcome Measures

Primary Outcomes (3)

• To evaluate spontaneous regression/progression over a 2-year period according to HPV HR genotyping

  Evaluate the risk of regression or progression of cervical lesion in patients with HG (high-grade) cervical precancerous lesion - according to stratification of HPV genotyping

  2 year follow up

• To evaluate spontaneous regression/progression over a 2-year period according to methylation results

  Evaluate the risk of regression or progression of cervical lesion in patients with HG cervical precancer - according to methylation test (FAM194A, miR124-2)

  2 year follow up

• o evaluate spontaneous regression/progression over a 2-year period according to CinTec plus

  Evaluate the risk of regression or progression of cervical lesion in patients with HG cervical precancer - according to CinTec plus test - mmunohistochemical marker utilizing two proteins - p16 and Ki67

  2 year follow up

Study Arms (2)

Unvaccinated

Without adjuvant vaccination for HPV

Vaccinated

Adjuvantly vaccinated against HPV with Gardasil-9

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Females with HG precancerous lesions of the cervix.

You may qualify if:

• Informed Consent
• cervical biopsy - HG lesion
• Age: 18-46 years
• colposcopicaly visible transformation zone
• HPV: Unvaccinated
• cytology all except AIS, adenocarcinoma, squamous cell carcinoma, AGC NEO

You may not qualify if:

• cytology AIS, AGC NEO, adenocarcinoma, squamous cell carcinoma
• immunosuppression
• active autoimmune disease
• history of cervical cryodestruction
• HPV vaccinated prior to start of the study

Sponsors & Collaborators

• Nikola Janovska: lead

Study Sites (1)

University Hospital Kralovske Vinohrady

Prague, 10034, Czechia

RECRUITING

Related Publications (3)

• Lee MH, Finlayson SJ, Gukova K, Hanley G, Miller D, Sadownik LA. Outcomes of Conservative Management of High Grade Squamous Intraepithelial Lesions in Young Women. J Low Genit Tract Dis. 2018 Jul;22(3):212-218. doi: 10.1097/LGT.0000000000000399.

  PMID: 29762428 BACKGROUND

• Kyrgiou M, Athanasiou A, Paraskevaidi M, Mitra A, Kalliala I, Martin-Hirsch P, Arbyn M, Bennett P, Paraskevaidis E. Adverse obstetric outcomes after local treatment for cervical preinvasive and early invasive disease according to cone depth: systematic review and meta-analysis. BMJ. 2016 Jul 28;354:i3633. doi: 10.1136/bmj.i3633.

  PMID: 27469988 BACKGROUND

• Depuydt CE, Jonckheere J, Berth M, Salembier GM, Vereecken AJ, Bogers JJ. Serial type-specific human papillomavirus (HPV) load measurement allows differentiation between regressing cervical lesions and serial virion productive transient infections. Cancer Med. 2015 Aug;4(8):1294-302. doi: 10.1002/cam4.473. Epub 2015 May 20.

  PMID: 25991420 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

cytology, cervical biopsy

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions

Study Officials

• Lukas Rob, Prof., MUDr., Csc.

  University Hospital Kralovske Vinohrady

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukas Rob, Prof. MUDr., Csc.

CONTACT

+420 296472368; lukas.rob@fnkv.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical doctor, Department of Gynecology and Obstetrics

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 13, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

CZ (1)