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RecruitingNCT06967740Updated Jul 31, 2025

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

An observational study in Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN) and Risk Factors, sponsored by Nikola Janovska. Recruiting at 1 site in Czechia. Open to female participants aged 18 Years to 46 Years. Per ClinicalTrials.gov, last updated 2025-07-31.

Sponsored by Nikola Janovska · Observational

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 46 Years
Sex
Female
01

Study 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.
02

Conditions studied

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

Keywords

  • Cervical Intraepithelial Neoplasia (CIN)
  • Conservative management
  • Precancerous cervical lesions
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 565 are open to participants now.

This study's planned enrollment of 200 is close to the median of 220 across 419 observational studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

This is the only study on the registry with Nikola Janovska as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 46 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Females with HG precancerous lesions of the cervix.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • cytology AIS, AGC NEO, adenocarcinoma, squamous cell carcinoma
  • immunosuppression
  • active autoimmune disease
  • history of cervical cryodestruction
  • HPV vaccinated prior to start of the study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Unvaccinated

    Without adjuvant vaccination for HPV

  • Vaccinated

    Adjuvantly vaccinated against HPV with Gardasil-9

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 year follow up

  2. 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)

    Time frame: 2 year follow up

  3. 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

    Time frame: 2 year follow up

07

Study locations

1 of 1 sites recruiting
  • University Hospital Kralovske Vinohrady
    Prague, 10034, Czechia
    • Lukas Rob, Prof., MUDr., Csc. · Contact · lukas.rob@fnkv.cz · +420 296472368
    • Nikola Janovska, MUDr. · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 29762428 ↗
  • 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. PubMed 27469988 ↗
  • 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. PubMed 25991420 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06967740
Lead sponsor
Nikola Janovska
Responsible party
Nikola Janovska (Medical doctor, Department of Gynecology and Obstetrics, Faculty Hospital Kralovske Vinohrady) — Sponsor-investigator
First posted
May 13, 2025
Start date
Nov 1, 2024
Primary completion
Dec 2028 (estimated)
Completion
Dec 2029 (estimated)
Last update
Jul 31, 2025

Study contacts

Lukas Rob, Prof. MUDr., Csc.
Contact
lukas.rob@fnkv.cz
+420 296472368
Lukas Rob, Prof., MUDr., Csc.
principal investigator · Vascular surgery, University hospital Královské Vinohrady, Prague

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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