DNA Methylation Biomarkers for Cervical Cancer Screening

• Conditions: Cervical Cancer; Cervical Intraepithelial Neoplasia

• Registration Number: NCT02605941
• Lead Sponsor: iStat Biomedical CO., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Status Verified: 2015-11
• Study First Submitted: 2015-11-06
• Study First Submitted QC: 2015-11-12
• Last Update Submitted: 2015-11-12
• Study First Posted: 2015-11-17
• Last Update Posted: 2015-11-17
• Primary Completion: 2015-12
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance of DNA methylation in identification of CIN3 or worse.	3 years	Patient's information, including clinical diagnosis and the molecular testing results etc., will be collected. Performances of the screening tools will be compared.

Trial Locations

Locations (1)

Mackay Memorial Hospital, Linkou Chang Gung Memorial Hospital, Lin-Shin Medical Corporation Lin-Shin Hosptial; 🇨🇳 Taipei, Taoyuan, and Taichung, Taiwan