Cell-free DNA Methylation Markers for Cancer Screening

Cancer Screening Clinical Trial

Official title:

Cell-free DNA Methylation Markers for Cancer Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03096938
• Other study ID #: cancer screening
• Status: Recruiting
• Phase: N/A
• First received: March 15, 2017
• Last updated: December 25, 2017
• Start date: June 1, 2017
• Est. completion date: May 1, 2021

Study information

• Verified date: December 2017
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: May 1, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Screening

Intervention

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

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (1)

Imperiale TF, Ransohoff DF, Itzkowitz SH, Levin TR, Lavin P, Lidgard GP, Ahlquist DA, Berger BM. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014 Apr 3;370(14):1287-97. doi: 10.1056/NEJMoa1311194. Epub 2014 Mar 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity (true positive rate)	The proportion of persons with disease who have a positive test (positive test results among persons with disease)	2 year
Primary	Specificity (true negative rate)	The proportion of persons without disease who have a negative test (negative test results among persons without disease)	2 year