MedDataX Logo

Predicting Treatment Failure in HSIL Patients with Positive Margins After Conization Via Detection of PAX1 Methylation

NCT ID: NCT06713655

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-31

Study Completion Date

2028-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

High-grade Squamous Intraepithelial Lesions (HSIL) Cervical Conization

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

cervical intraepithelial neoplasia conization positive margins cervical cancer treatment failure residual/recurrent disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

26 Years

Maximum Eligible Age

54 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Huzhou Maternity and Child Care Hospital

UNKNOWN

Sponsor Role collaborator

Jiaxing Maternity and Child Health Care Hospital

OTHER

Sponsor Role collaborator

Shaoxing Maternity and Child Health Care Hospital

OTHER

Sponsor Role collaborator

Ningbo No. 1 Hospital

OTHER

Sponsor Role collaborator

Jinhua Central Hospital

OTHER

Sponsor Role collaborator

Taizhou Hospital Zhejiang Province

UNKNOWN

Sponsor Role collaborator

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Weiguo Lv

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lv Weiguo, Ph.D

Role: CONTACT

Phone: 86-13588819218

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lv Weiguo

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB-20240248-R

Identifier Type: -

Identifier Source: org_study_id