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The significance of gene methylation detection in hierarchical management of cervical precancerous lesions screening and exploration of its application in special populations.

The significance of gene methylation detection in hierarchical management of cervical precancerous lesions screening and exploration of its application in special populations.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300072548
Enrollment
Unknown
Registered
2023-06-16
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

Treatment of cervical HPV infection and prevention of cervical cancer

Interventions

Gold Standard:Cervical biopsy under colposcopy and cervical scraping were performed, and tissues were taken for pathological examination as the standard for grouping. They were divided into inflammati
Index test:Perform methylation detection of PAX1, EPB41L3, FAM19A4, and ZNF582 genes on cervical exfoliated cells

Sponsors

Zhangjiagang Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: a. 18 years old or above; b. According to the standards of the American Cancer Society, the Colposcopy and Cervical Pathology Society, and the American Clinical Pathology Screening Guidelines, cytological abnormalities and/or hrHPV abnormalities; c. Samples can be used for methylation analysis in this project; d. The cervical histological and pathological results confirmed by this study; e. No history of cervical precancerous lesions or other cancers; f. No history of radiation therapy; g. HIV results were negative, and there was no history of organ transplantation or immunosuppression treatment; h. The patient is informed and willing to participate in the study.

Exclusion criteria

Exclusion criteria: During the research process, researchers or other authorized personnel have the right to exclude subjects who meet the following conditions: a. Poor compliance, and researchers believe that clinical research cannot be completed b. Using other medications that affect the treatment plan c. The subject is unwilling to continue clinical research and proposes to withdraw from the study d. At the review meeting, it is up to the main researchers and statisticians to decide whether to exclude the cases. The case report form that excludes the cases should be retained and archived for future reference.

Design outcomes

Primary

MeasureTime frame
Methylation levels of PAX1, EPB41L3, FAM19A4, and ZNF582 genes;accuracy;sensitivity;specificity;

Countries

China

Contacts

Public ContactYing Sha

Zhangjiagang Second People's Hospital

zjgmusicsha@163.com+86 139 1361 2332

Outcome results

None listed

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