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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 23 November 2015
Main ID:  NCT02605941
Date of registration: 06/11/2015
Prospective Registration: No
Primary sponsor: iStat Biomedical CO., Ltd.
Public title: DNA Methylation Biomarkers for Cervical Cancer Screening
Scientific title: DNA Methylation Biomarkers for Cervical Cancer Screening
Date of first enrolment: February 2014
Target sample size: 5000
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02605941
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Taiwan
Contacts
Name:     Chih-Long Chang, MD, Ph.D.
Address: 
Telephone:
Email:
Affiliation:  Mackay Memorial Hospital
Name:     Shih-chu Ho, MD
Address: 
Telephone:
Email:
Affiliation:  Lin-Shin Medical Corporation Lin-Shin Hosptial
Name:     Ting-Chang Chang, MD., MPH.
Address: 
Telephone:
Email:
Affiliation:  Linkou Chang Gung Memorial Hospital
Name:     Chien-Ping Hung
Address: 
Telephone: +886-2-2696-3518
Email: apple@istatbio.com
Affiliation: 
Name:     Yuh-cheng Yang, MD
Address: 
Telephone:
Email:
Affiliation:  Mackay Memorial Hospital
Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: N/A
Gender: Female
Health Condition(s) or Problem(s) studied
Cervical Cancer
Cervical Intraepithelial Neoplasia
Intervention(s)
Primary Outcome(s)
Performance of DNA methylation in identification of CIN3 or worse. [Time Frame: 3 years]
Secondary Outcome(s)
Secondary ID(s)
epigene-13151
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Mackay Memorial Hospital
Chang Gung Memorial Hospital
Lin-Shin Medical Corporation Lin-Shin Hosptial
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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