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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age26-54
SponsorWomen's Hospital School Of Medicine Zhejiang University

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Sponsors and collaborators

Women's Hospital School Of Medicine Zhejiang University

Lead sponsor

Huzhou Maternity and Child Care Hospital

Collaborator

Jiaxing Maternity and Child Health Care Hospital

Collaborator

Shaoxing Maternity and Child Health Care Hospital

Collaborator

Ningbo No. 1 Hospital

Collaborator

Jinhua Central Hospital

Collaborator

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Collaborator