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Predictive Study on the Correlation Between Methylation Detection and Pathological Outcomes of Conization in Cervical Intraepithelial Neoplasia (CIN)

Predictive Study on the Correlation Between Methylation Detection and Pathological Outcomes of Conization in Cervical Intraepithelial Neoplasia (CIN)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116456
Enrollment
Unknown
Registered
2026-01-09
Start date
2023-10-01
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical intraepithelial neoplasia

Interventions

Index test:Cervical methylation testing

Sponsors

The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Voluntary participation in this study; 2.Aged 18-65 years; 3.Patients with cervical biopsy-confirmed cervical lesions (CIN?-CIN?) , scheduled for cervical conization via Loop Electrosurgical Excision Procedure (LEEP); 4.Availability of pre-enrollment test results within 3 months: High-risk HPV genotyping test Cervical exfoliative cytology test (Pap smear) Serum SCC antigen test Colposcopy examination Preoperative/Postoperative cervical biopsy pathology reports; 5.Carried out the collection and testing of six gene methylation specimens at the outpatient department; 6.Be able to follow the visit and related procedures as stipulated in the plan;

Exclusion criteria

Exclusion criteria: 1. Women during pregnancy or lactation period; 2. Those without surgical indications; 3. Cervical cancer patients; 4.Previously, physical therapy or surgical treatment, radiotherapy and chemotherapy were performed due to cervical lesions or cervical cancer. 5.The researchers believe that any situation that might increase the risk for the subjects; 6.Those who are unable to complete the treatment course;

Design outcomes

Primary

MeasureTime frame
Methylation test results: Positive and negative as well as scores;

Secondary

MeasureTime frame
Demographic data: sex, age, etc.;Clinical Diagnosis: Collect pathological grading results, type of cervical transformation zone, lesion size under colposcopy, etc.;Association between cone biopsy results and methylation levels;

Countries

China

Contacts

Public ContactJia Ying

The First Affiliated Hospital of Chongqing Medical University

617418550@qq.com+86 23 89011876

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026