Dual-Modality Immunotherapy for HPV Clearance (DUAL-HPV)
Turkey (Türkiye)76 participantsStarted 2026-04-28
Plain-language summary
Persistent high-risk human papillomavirus infection is an important precursor of cervical cancer and related cervical lesions. This single-center, randomized, assessor-blinded, parallel-group controlled trial evaluates whether dual-modality immunotherapy consisting of an oral immunomodulator plus a vaginal ovule improves HPV clearance compared with standard supportive care. A total of 76 participants will be randomized in a 1:1 ratio. The primary outcome is HPV clearance confirmed by repeat HPV testing and cervical cytology after the 3-month treatment period. Treatment adherence and adverse events will also be monitored.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female patients aged 18-65 years.
* Confirmed persistent high-risk human papillomavirus (HR-HPV) infection.
* Histologically confirmed CIN 1 or cytological diagnosis of ASC-US or LSIL.
* Eligible for conservative follow-up without immediate excisional treatment.
* Ability to provide written informed consent and comply with study procedures.
Exclusion Criteria:
* HSIL, CIN2, CIN3, adenocarcinoma in situ, or invasive cervical cancer.
* Pregnancy or breastfeeding.
* Immunodeficiency or current immunosuppressive therapy.
* Previous treatment for cervical dysplasia within the last 6 months.
* Planned colposcopy, cervical biopsy, or LEEP during the 3-month study period.
* Known hypersensitivity to any study intervention.
* Participation in another interventional clinical trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HPV clearance rate
Timeframe: 3 months
Trial details
NCT IDNCT07735039
SponsorDr. Lutfi Kirdar Kartal Training and Research Hospital