Cell-free DNA Methylation Markers for Cancer Screening

December 25, 2017 updated by: Ruihua Xu, Sun Yat-sen University
The purpose of this study is to evaluate the role of cell-free DNA methylation markers in cancer screening.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15000

Phase

  • Not Applicable

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

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun yat-sen University Cancer Center
        • Contact:
        • Contact:

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

40 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is average risk for development of cancer
  2. Subject able and willing to undergo screening test within 90 days of enrollment
  3. Subject is 40 to 74 years of age inclusive
  4. Subject is able to comprehend, sign, and date the written informed consent document to participate in the study

Exclusion Criteria:

  1. Subject has any condition which, in the opinion of the investigator should preclude participation in the study
  2. Subject has a history of cancer
  3. Participation in any "interventional" clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups.

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

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Normal screening group
patients receive the routine screening examination
Diagnostic test: methylation markers screening
Cell-free DNA extraction from plasma samples-Bisulfite conversion of cfDNA-Determination of DNA methylation levels by deep sequencing-Sequencing data analysis
Experimental: methylation markers screening group
patients receive the methylation markers screening
Diagnostic test: methylation markers screening
Cell-free DNA extraction from plasma samples-Bisulfite conversion of cfDNA-Determination of DNA methylation levels by deep sequencing-Sequencing data analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity (true positive rate)
Time Frame: 2 year
The proportion of persons with disease who have a positive test (positive test results among persons with disease)
2 year
Specificity (true negative rate)
Time Frame: 2 year
The proportion of persons without disease who have a negative test (negative test results among persons without disease)
2 year

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

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 (Actual)

June 1, 2017

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

March 15, 2017

First Submitted That Met QC Criteria

March 29, 2017

First Posted (Actual)

March 30, 2017

Study Record Updates

Last Update Posted (Actual)

December 27, 2017

Last Update Submitted That Met QC Criteria

December 25, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • cancer screening

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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