DNA Methylation Biomarkers for Cervical Cancer Screening

iStat Biomedical CO., Ltd.5,000 enrolled

Overview

The purpose of this prospective study is to evaluate whether DNA methylation can be applied in cervical cancer screening.

Study Type

OBSERVATIONAL

Enrollment

5,000

Conditions

Cervical Intraepithelial Neoplasia Cervical Cancer

Eligibility

Sex: FEMALEMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * women with age ≥20 and sexual experience * Agree to sign ICF Exclusion Criteria: * women had received Hysterectomy * women had destructive therapy for cervical lesions in 6 months, for examples: conization, Laser or cryotherapy, chemotherapy, and radiation therapy * Women are at pregnancy or had baby delivery in 6 weeks

Locations (1)

Mackay Memorial Hospital, Linkou Chang Gung Memorial Hospital, Lin-Shin Medical Corporation Lin-Shin Hosptial

Taipei, Taoyuan, and Taichung, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Performance of DNA methylation in identification of CIN3 or worse.

Patient's information, including clinical diagnosis and the molecular testing results etc., will be collected. Performances of the screening tools will be compared.

Time frame: 3 years

Central Contacts

Chien-Ping Hung

CONTACT

+886-2-2696-3518 apple@istatbio.com

Hsiu-yuan Tsao

CONTACT

+886-2-2696-3518 hytsao@istatbio.com

Data from ClinicalTrials.gov

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