---
title: Role of Methylation Test Triage in HPV Positive Women
nct_id: NCT06366516
overall_status: UNKNOWN
phase: NA
sponsor: Obstetrics & Gynecology Hospital of Fudan University
study_type: INTERVENTIONAL
primary_condition: Precancerous Cervical Lesion
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06366516.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06366516"
ct_last_update_post_date: 2024-04-16
last_seen_at: "2026-05-12T07:27:26.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Role of Methylation Test Triage in HPV Positive Women

**Official Title:** Clinical Validation of ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671 Methylation in HPV Positive Women: a Multi-center RCT From China

**NCT ID:** [NCT06366516](https://clinicaltrials.gov/study/NCT06366516)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 10000
- **Lead Sponsor:** Obstetrics & Gynecology Hospital of Fudan University
- **Collaborators:** Peking Union Medical College Hospital, Chengdu Women's and Children's Central Hospital, Guangdong Women and Children Hospital, Second Hospital of Jilin University, First Affiliated Hospital of Xinjiang Medical University, Third Affiliated Hospital of Zhengzhou University
- **Conditions:** Precancerous Cervical Lesion
- **Start Date:** 2024-04
- **Completion Date:** 2026-02
- **CT.gov Last Update:** 2024-04-16

## Brief 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.

## Detailed Description

The study is divided into two phases, a baseline (cross-sectional) phase and a 1-year follow-up phase. Women who meet the clinical endpoint (i.e. histopathologically confirmed ≥CIN2 after baseline colposcopy/biopsy) are withdrawn from the study. Participants who do not meet the primary endpoint/treat at baseline will invited to participate in the follow-up phase of the trial. Participants included in the follow-up phase are underwent HPV, cytology, and methylation tests at 6 months and 1 year after baseline.Similar to the baseline phase,participants were referred to colposcopy/biopsy if any of the cytology and HPV tests result is positive.

## Eligibility

- **Minimum age:** 25 Years
- **Maximum age:** 65 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Women aged 25-65 years with high-risk HPV infection.** (EXPERIMENTAL) — Ten thousand women were recruited who aged 25-65 years and they are positive for high-risk HPV.

## Interventions

- **Methylation Test** (DIAGNOSTIC_TEST) — Participants who aged 25-65 years with high-risk HPV infection are recruited.To start with,cervical exfoliated cells are collected, coded (according to the actual enrollment sequence), and stored in the pathology department where methylation testing is performed.In addition,patients will underwent colposcopy and biopsy.

Patients are followed up by cytology, high-risk HPV and methylation tests at 6 and 12 months after enrollment.Cervical conization and hysterectomy will be taken if necessary according to histopathological results. The clinical endpoint is reached when CIN2+ is confirmed by histopathological result.

## Primary Outcomes

- **The sensitivity and specificity of methylation test in detecting CIN2+.** _(time frame: From date of enrollment until the date of first documented CIN2+,assessed up to 12 months)_ — The primary variable of methylation test are as follows:clinical sensitivity, clinical specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, positive coincidence rate, and negative coincidence rate.

## Secondary Outcomes

- **KAPPA value of methylation test.** _(time frame: From date of enrollment until the date of first documented CIN2+,assessed up to 12 months)_

## Locations (1)

- Obstetrics and Gynecology Hospital of Fudan University, Shanghai, Shanghai Municipality, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.obstetrics and gynecology hospital of fudan university|shanghai|shanghai municipality|china` — added _(2026-05-12)_

---

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