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

NCT06713655 | Not Yet Recruiting

• 1 other identifier: IRB-20240248-R
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

High-grade Squamous Intraepithelial Lesions (HSIL); Cervical Conization

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

  2 years post-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

Eligibility Criteria

• Age: 26 Years - 54 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead
• Huzhou Maternity and Child Care Hospital: collaborator
• Jiaxing Maternity and Child Health Care Hospital: collaborator
• Shaoxing Maternity and Child Health Care Hospital: collaborator
• Ningbo No. 1 Hospital: collaborator
• Jinhua Central Hospital: collaborator
• Taizhou Hospital Zhejiang Province: collaborator

Study Sites (1)

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Squamous Intraepithelial Lesions; Uterine Cervical Dysplasia; Margins of Excision; Uterine Cervical Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Disease Attributes; Pathologic Processes

Central Study Contacts

Lv Weiguo, Ph.D

CONTACT

86-13588819218; lbwg@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 3, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: December 6, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)