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Recruiting NCT06967740

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

— Observational Cervical Cancer Cervical Intraepithelial Neoplasia (CIN) Risk Factors Conservative Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN), Risk Factors, Conservative Management. Basic parameters: 18 years — 46 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • To evaluate spontaneous regression/progression over a 2-year period according to HPV HR genotyping [Time frame: 2 year follow up]
  • To evaluate spontaneous regression/progression over a 2-year period according to methylation results [Time frame: 2 year follow up]
  • o evaluate spontaneous regression/progression over a 2-year period according to CinTec plus [Time frame: 2 year follow up]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Czechia · 1 center
  • University Hospital Kralovske Vinohrady — Prague

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. PMID 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. PMID 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. PMID 25991420

Identifiers

NCT: NCT06967740 · EKVP/51/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗