Cell-free DNA Methylation Markers for Cancer Screening

Not Applicable

• Conditions: Cancer Screening
• Interventions: Diagnostic Test: methylation markers screening

• Registration Number: NCT03096938
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The purpose of this study is to evaluate the role of cell-free DNA methylation markers in cancer screening.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-29
• Study First Posted: 2017-03-30
• Study Start: 2017-06-01
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-25
• Last Update Posted: 2017-12-27
• Primary Completion: 2020-10-01
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Normal screening group	methylation markers screening	patients receive the routine screening examination
methylation markers screening group	methylation markers screening	patients receive the methylation markers screening

Primary Outcome Measures

Name	Time	Method
sensitivity (true positive rate)	2 year	The proportion of persons with disease who have a positive test (positive test results among persons with disease)
Specificity (true negative rate)	2 year	The proportion of persons without disease who have a negative test (negative test results among persons without disease)

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China