An observational study in High-grade Squamous Intraepithelial Lesions (HSIL) and Cervical Conization, sponsored by Women's Hospital School Of Medicine Zhejiang University. Not yet recruiting at 1 site in China. Open to female participants aged 26 Years to 54 Years. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by Women's Hospital School Of Medicine Zhejiang University · Observational
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.
This study is a multicenter, prospective observational study that qualitatively assesses the methylation status of the PAX1 gene in cervical exfoliated cells from patients with HSIL and positive margins after conization. The aim is to evaluate the ability of PAX1 gene methylation testing to predict treatment failure (lesion recurrence or persistence). The first follow-up occurs 6 months post-surgery, including high-risk human papillomavirus (hrHPV) testing and cytology, with referral for colposcopy, including biopsy and/or endocervical curettage (ECC), if necessary. Subsequent management and follow-up are based on examination results, following clinical guidelines, and arranged at intervals of 6-12 months depending on the findings. The follow-up includes routine clinical examinations widely applied in practice, and PAX1 testing will be completed at each follow-up visit. PAX1 testing, like hrHPV testing and cytology, will be performed using cervical exfoliated cells.
Women undergoing their first cervical conization surgery for treatment or diagnosis at seven hospitals mentioned above in Zhejiang Province.
Exclusion Criteria:
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
Time frame: 2 years post-surgery
Sensitivity of the PAX1 methylation to detect treatment failure
Time frame: 2 years post-surgery
specificity of the PAX1 methylation to detect treatment failure
Time frame: 2 years post-surgery
Plan to share: No
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This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Squamous Intraepithelial Lesions of the Cervix→
Women's Hospital School Of Medicine Zhejiang University