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)
Facility
City
Region
Status
Women's Hospital School Of Medicine Zhejiang University
Hangzhou
Zhejiang
More Women's Hospital School Of Medicine Zhejiang University trials in China
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.
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