Clinical Trial on Cervical Cancer, Cervical Intraepithelial Neoplasia - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Taiwan
- - Taipei, Taoyuan, and Taichung, Taiwan
    - Recruiting
    - Mackay Memorial Hospital, Linkou Chang Gung Memorial Hospital, Lin-Shin Medical Corporation Lin-Shin Hosptial
    - Principal Investigator:
      
      Yuh-cheng Yang, MD
    - Sub-Investigator:
      
      Shih-chu Ho, MD
    - Sub-Investigator:
      
      Ting-Chang Chang, MD., MPH.
    - Sub-Investigator:
      
      Chih-Long Chang, MD, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Investigators plan to recruit 5,000 women to participate this study in Taiwan. Papanicolaou test, high-risk HPV typing and DNA methylation will be co-tested. It is expected to find an optimal solution for molecular cervical cancer screening. The participant will be recruited by Mackay Memorial Hospital, Chang Gung Memorial Hospital, and Lin-Hsin Hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iStat Biomedical CO., Ltd.

Collaborators

Mackay Memorial Hospital

Chang Gung Memorial Hospital

Li Shin Hospital

Investigators

Study Chair: Yuh-cheng Yang, MD, MacKay Memorial Hospital
Principal Investigator: Shih-chu Ho, MD, Li Shin Hospital
Principal Investigator: Ting-Chang Chang, MD., MPH., Chang Gung Memorial Hospital
Principal Investigator: Chih-Long Chang, MD, Ph.D., MacKay Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

November 6, 2015

First Submitted That Met QC Criteria

November 12, 2015

First Posted (Estimate)

November 17, 2015

Study Record Updates

Last Update Posted (Estimate)