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.
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.
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;
Women undergoing their first cervical conization surgery for treatment or diagnosis at seven hospitals mentioned above in Zhejiang Province.
Cohort
Prospective
Not listed
Treatment failure rate within 24 months after surgery (cervical intraepithelial neoplasia grade 2+ (CIN2+) recurrence/residual rates)
the percentage of HSIL treatment failure (CIN2+ recurrence and residual) within 24 months after surgery
Sensitivity of the PAX1 methylation to detect treatment failure
specificity of the PAX1 methylation to detect treatment failure
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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
This trial is not recruiting at the moment. You can still explore other options:
