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Clinical Trials in China / NCT06713655
Starting soon Observational

Predicting Treatment Failure in HSIL Patients with Positive Margins After Conization Via Detection of PAX1 Methylation

NCT06713655 · tracked via the Priya Life Science China tracker
Sponsor
Women's Hospital School Of Medicine Zhejiang University
Phase
Observational
Started
2024-12
Last updated
2024-12-06

Condition(s) studied

High-grade Squamous Intraepithelial Lesions (HSIL)Cervical Conization

Study summary

The goal of this multicenter, observational study is to evaluate whether methylation testing of paired box gene 1 (PAX1) can better predict and diagnose recurrence or persistent disease in patients with positive margins after cervical conization for high-grade squamous intraepithelial lesion (HSIL). The main question it aims to answer is:

Can PAX1 gene methylation testing provide a more accurate and effective prediction and diagnosis of cervical disease recurrence/persistence in addition to existing methods? Participants will be managed according to the latest clinical guidelines, and during follow-up, a non-invasive test, PAX1 gene methylation testing, will be added.

Eligibility

Sex
FEMALE
Min age
26 Years
Max age
54 Years
Healthy volunteers
No
Inclusion Criteria: * Age greater than 25 years and less than 55 years; * First-time cervical conization (cold knife conization or loop electrosurgical excision procedure); * Postoperative pathology showing HSIL (CIN2 or CIN3); * Positive margins for HSIL (CIN2 or CIN3) in conization specimen. Exclusion Criteria: * The presence of other malignant tumors or precancerous lesions; * Lack of willingness for follow-up; * Pregnant or breastfeeding women; * Unable or unwilling to complete follow-up examinations; * History of prior cervical disease treatment (surgical or physical therapy); * Presence of immune system disorders.

Primary outcome measure(s)

  • Treatment failure rate within 24 months after surgery (cervical intraepithelial neoplasia grade 2+ (CIN2+) recurrence/residual rates) — 2 years post-surgery
    the percentage of HSIL treatment failure (CIN2+ recurrence and residual) within 24 months after surgery
  • Sensitivity of the PAX1 methylation to detect treatment failure — 2 years post-surgery
  • specificity of the PAX1 methylation to detect treatment failure — 2 years post-surgery

Trial sites (1)

FacilityCityRegionStatus
Women's Hospital School Of Medicine Zhejiang University Hangzhou Zhejiang

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06713655 on ClinicalTrials.gov ↗ ← All trials in China