Clinical trial NCT06713655: Predicting Treatment Failure in HSIL Patients with Positive Margins After Conization Via Detection of PAX1 Methylation
Official title: Multicenter Study on PAX1 Methylation for Predicting Lesion Persistence/Recurrence in HSIL Patients with Positive Margins After Cervical Conization
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: High-grade Squamous Intraepithelial Lesions (HSIL)
Cervical Conization
Keywords: cervical intraepithelial neoplasia
conization
positive margins
cervical cancer
treatment failure
residual/recurrent disease
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
Collaborators: name: Huzhou Maternity and Child Care Hospital
name: Jiaxing Maternity and Child Health Care Hospital
name: Shaoxing Maternity and Child Health Care Hospital
name: Ningbo No. 1 Hospital
name: Jinhua Central Hospital
name: Taizhou Hospital Zhejiang Province
First posted: 2024-12-03
Enrollment: 800
Sex: FEMALE
Minimum age (years): 26
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing their first cervical conization surgery for treatment or diagnosis at seven hospitals mentioned above in Zhejiang Province.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 outcomes:
measure: Treatment failure rate within 24 months after surgery (cervical intraepithelial neoplasia grade 2+ (CIN2+) recurrence/residual rates)
timeFrame: 2 years post-surgery
measure: Sensitivity of the PAX1 methylation to detect treatment failure
timeFrame: 2 years post-surgery
measure: specificity of the PAX1 methylation to detect treatment failure
timeFrame: 2 years post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's Hospital School Of Medicine Zhejiang University
state: Zhejiang
Study officials:
References: