Role of Methylation Test Triage in HPV Positive Women (MTTRIHPW)

Obstetrics & Gynecology Hospital of Fudan University

Status: Not yet enrolling

Conditions: Precancerous Cervical Lesion

Treatments: Diagnostic Test: Methylation Test

Study type: Interventional

Funder types: Other

Identifiers

NCT06366516

FUOBGY2024-23

Details and patient eligibility

About

The pathological results were used as the gold standard in this study and the investigators analyze the diagnostic value of six gene methylation status (ASTN1 DLX1, ITGA4, RXFP3, SOX17, ZNF671) in triaging high-risk human papillomavirus infection. The sensitivity and specificity of methylation test and cytology in the diagnosis of high-grade cervical lesions are compared in order to providing new methods and basis in improving the accuracy of cervical cancer screening.

Full description

The study is divided into two phases, a baseline (cross-sectional) phase and a 1-year follow-up phase. Women who meet the clinical endpoint (i.e. histopathologically confirmed ≥CIN2 after baseline colposcopy/biopsy) are withdrawn from the study. Participants who do not meet the primary endpoint/treat at baseline will invited to participate in the follow-up phase of the trial. Participants included in the follow-up phase are underwent HPV, cytology, and methylation tests at 6 months and 1 year after baseline.Similar to the baseline phase,participants were referred to colposcopy/biopsy if any of the cytology and HPV tests result is positive.

Enrollment: 10,000 estimated patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged 25~65 years undergoing cervical cancer screening
• normal for cytology and positive for hrHPV
• informed consent was obtained

Exclusion criteria

• pregnant
• with a known history of ablation or treatment with cervical excision within 12 months
• hysterectomy
• chemoradiotherapy
• planning to participate or taking part in another cancer screening, treatment, or vaccination study
• do not meet the inclusion criteria
• give up the trial or naturally dropped out of the follow-up during the observation process
• people who asked to withdraw

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10,000 participants in 1 patient group

Women aged 25-65 years with high-risk HPV infection.

Experimental group

Description:

Ten thousand women were recruited who aged 25-65 years and they are positive for high-risk HPV.

Treatment:

Diagnostic Test: Methylation Test