DNA Methylation Biomarkers for Cervical Cancer Screening

iStat Biomedical CO., Ltd.1 site in 1 country5,000 target enrollmentFebruary 2014

ConditionsCervical Intraepithelial Neoplasia Cervical Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cervical Intraepithelial Neoplasia
Sponsor: iStat Biomedical CO., Ltd.
Enrollment: 5000
Locations: 1
Primary Endpoint: Performance of DNA methylation in identification of CIN3 or worse.
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

August 2016

Last Updated

10 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

iStat Biomedical CO., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Performance of DNA methylation in identification of CIN3 or worse.

Time Frame: 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.