Role of Methylation Test Triage in HPV Positive Women (NCT06366516) | Clinical Trial Compass
UnknownNot Applicable
Role of Methylation Test Triage in HPV Positive Women
China10,000 participantsStarted 2024-04
Plain-language summary
The pathological results were used as the gold standard in this study and the investigators analyze the diagnostic value of six gene methylation status (ASTN1 DLX1, ITGA4, RXFP3, SOX17, ZNF671) in triaging high-risk human papillomavirus infection. The sensitivity and specificity of methylation test and cytology in the diagnosis of high-grade cervical lesions are compared in order to providing new methods and basis in improving the accuracy of cervical cancer screening.
Who can participate
Age range
25 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:
* aged 25\~65 years undergoing cervical cancer screening
* normal for cytology and positive for hrHPV
* informed consent was obtained
Exclusion Criteria:
* pregnant
* with a known history of ablation or treatment with cervical excision within 12 months
* hysterectomy
* chemoradiotherapy
* planning to participate or taking part in another cancer screening, treatment, or vaccination study
* do not meet the inclusion criteria
* give up the trial or naturally dropped out of the follow-up during the observation process
* people who asked to withdraw
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
The sensitivity and specificity of methylation test in detecting CIN2+.
Timeframe: From date of enrollment until the date of first documented CIN2+,assessed up to 12 months
Trial details
NCT IDNCT06366516
SponsorObstetrics & Gynecology Hospital of Fudan University