Clinical trial NCT06967740: Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs
Official title: Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Cervical Intraepithelial Neoplasia (CIN)
Risk Factors
Conservative Management
Keywords: Cervical Intraepithelial Neoplasia (CIN)
Conservative management
Precancerous cervical lesions
Lead sponsor: Faculty Hospital Kralovske Vinohrady
Sponsor class: OTHER_GOV
First posted: 2025-05-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females with HG precancerous lesions of the cervix.

Brief summary: The primary aim of this study is to develop a recommended clinical practice guideline for managing women with HPV HR 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 results.


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

Primary outcomes:
measure: To evaluate spontaneous regression/progression over a 2-year period according to HPV HR genotyping
timeFrame: 2 year follow up
measure: To evaluate spontaneous regression/progression over a 2-year period according to methylation results
timeFrame: 2 year follow up
measure: o evaluate spontaneous regression/progression over a 2-year period according to CinTec plus
timeFrame: 2 year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: University Hospital Kralovske Vinohrady
Study officials:
affiliation: University Hospital Kralovske Vinohrady
name: Lukas Rob, Prof., MUDr., Csc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.