Study on the use of DNA methylation marker in different strategies of cervical cancer and precancerous lesions screening

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2100049202

Enrollment

Unknown

Registered

2021-07-25

Start date

2021-08-01

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

Cervical Lesions

Interventions

Gold Standard:The gold standard is pathological results of cervical tissue.In this study, colposcopy biopsy and/or ECC will be performed within 12 weeks of completion of HPV+cytology test according to

Index test:DNA methylation

Eligibility

Sex/Gender

Female

Age

30 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Women aged >= 30 years with a history of sexual life. 2. Cervical cancer screening (HPV and/or cytology test) in outpatient clinic, the initial screening result is positive, and the remaining samples can be collected enough for DNA testing. 3. Sign the informed consent form, be willing and able to undergo colposcopy, and have histological results that meet the diagnostic criteria. 4. No history of cervical cancer and precancerous lesions treatment.

Exclusion criteria

Exclusion criteria: 1. Pregnant women. 2. Women with immunodeficiency. 3. Women with a history of other gynecological malignancies and tumors. 4. Women with incomplete personal information: sampling unit, name, age, cytology test results, HPV test results, colposcopy pathology results, cytology history within 5 years, and history of colposcopy within 5 years.

Design outcomes

Primary

Measure	Time frame
DNA methylation;	—

Countries

China

Contacts

Public ContactYu Wenqiang

Obstetrics and Gynecology Hospital of Fudan University

wenqiangyu@fudan.edu.cn+86 15221889142

Outcome results

None listed

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