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DNA methylation biomarker as a screening test for detection of cervical cancer : a prospective cohort study

Screening for PCDHGB7 gene methylation in large cervical cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400085330
Enrollment
Unknown
Registered
2024-06-05
Start date
2024-06-10
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Uterine Cervical Lesions

Interventions

Additional follow-up group (DNA methylation was used to guide referral for colposcopy):None
Standard follow-up group (Referral for colposcopy according to the Chinese Cervical Cancer Screening Guideline):None

Sponsors

Heze Maternal and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1.Females aged 35-64 years with a history of sexual life. 2.The remaining cell samples for DNA methylation testing can be collected. 3.Sign the informed consent form, be willing and able to accept 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: sample collection unit, name, age, cytology test results, HPV test results, colposcopy pathology results, cytology history within 5 years, and history of colposcopy within 5 years. 5.Known history of history of high-grade cervical lesions and above (CIN2, CIN3, cervical cancer) and history of ablative, excisional therapy to the cervix. 6.Subjects enrolled withdraw from reasearch. 7.Unable to meet the minimum required sample size.

Design outcomes

Primary

MeasureTime frame
DNA methylation;Diagnosis proportion of CIN2+;

Secondary

MeasureTime frame
Diagnostic proportion of CIN3+;

Countries

China

Contacts

Public ContactChaohui Yuan; Longfang Xu

Heze Maternal and Child Health Hospital

hzbjylfx@126.com+86 186 0530 6848

Outcome results

None listed

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