NCT07376031Completed
Cervical Thermal Ablation to Treat Persistent HPV Infection
Effect of Thermal Ablation on Persistent HPV Infection in Danish Women ≥40 Years of Age; a Randomized Clinical Study
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
Thermal ablation of women ≥40 years of age with persistent Human papillomavirus (HPV) infection. A pilot and intervention study. Cervical heat treatment is a relatively new form of treatment19 where a smaller, defined area of the cervix is destroyed by insertion of a heated probe. Cervical heat treatment is already used in specialist medical practice for patients with erythroplakia, contact bleeding, chronic cervicitis and discharged. In a collaboration between Region Zealand and the Capital Region of Denmark, 120 women are randomized to receive thermal ablation for HPV infections without severe disease with a matched control group of 120 women who do not receive ablation. All women are monitored through repeated cervical cytology re-tests at defined follow-up (FU) times. The study cohort consist of 1) sample on enrollment date, 2) 3 months FU sample, 3) 6 months FU sample, 4) 12 months FU sample. All samples are collected in SurePath liquid-based cytology medium and HPV tested using the BD Onclarity HPV test (BD Integrated Diagnostic systems, Sparks, MD)20-22 supplemented by a full genotyping analysis (Seegene, Seoul, Korea)21,23. Methylation status is examined using the QiaSure FAM19A4/miRNA 122-4 methylation test (Qiagen, Hilden, Germany). This project element aims to determine whether thermal ablation impact viral clearance compared to the control group, and whether DNA methylation status is significant amongst women who are persistently HPV positive before and after thermal ablation.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 131 (actual)
- First submitted
- 21 Jan 2026
- Start date
- 1 Jan 2020
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Hvidovre University Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT07376031
What you commit to
- Study type: Interventional
- Participants enrolled: 131
- From 1 Jan 2020 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Women with histologically confirmed ≥CIN2
- biopsies lacking transformation zone tissue
Who the study is looking for
- Women, age ≥40 years;
- persistent high-risk human papillomavirus (HR-HPV) infection for ≥12 months
- colposcopy referral according to national screening guidelines;
- normal, ASC-US, or LSIL cytology;
- no histologically verified ≥CIN2; and no prior cervical treatment.
Age in the registry: 40 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dept. Pathology, AHH-Hvidovre Hospital Coordinator of this site? Confirm its status | Hvidovre | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.