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Testing PAX1 Methylation to Predict Cervical Lesion Return After Conization

Studies whether a PAX1 gene test can predict cervical lesion return in women after surgery.

Plain-language title generated from the registry record
Registry title: Predicting Treatment Failure in HSIL Patients with Positive Margins After Conization Via Detection of PAX1 Methylation

Key facts

Where
Hangzhou, ChinaSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women who had a first cervical conization for HSIL (CIN2 or CIN3) and whose removed tissue had positive margins for HSIL. A PAX1 methylation test is added during follow-up.

Age
Older than 25 and younger than 55 years (26 to 54 years).
Sex
Women only.
Disease stage
HSIL (CIN2 or CIN3) found after conization, with positive margins for HSIL in the removed tissue.
Earlier treatment
First-time cervical conization (cold knife conization or loop electrosurgical excision procedure). No earlier treatment of cervical disease, surgical or physical therapy.

Main reasons for not taking part

  • Other malignant tumors or precancerous lesions
  • Pregnant or breastfeeding women
  • Immune system disorders
  • Earlier surgical or physical treatment of cervical disease
  • Unable or unwilling to complete follow-up examinations

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 26 and 54 years old?

Source: NCT06713655, who can take part

Where in China

  • Women's hospital school of medicine Zhejiang UniversityHangzhou, ChinaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Women's Hospital School Of Medicine Zhejiang University
Trial code
NCT06713655
Record updated
6 December 2024
Original description
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:Read full original descriptionShow less

Multicenter Study on PAX1 Methylation for Predicting Lesion Persistence/Recurrence in HSIL Patients with Positive Margins After Cervical Conization

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.

Inclusion: 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: History of prior cervical disease treatment (surgical or physical therapy); The presence of other malignant tumors or precancerous lesions; Presence of immune system disorders; Lack of willingness for follow-up; Pregnant or breastfeeding women; Unable or unwilling to complete follow-up examinations.

ClinicalTrials.gov NCT06713655