Cell-free DNA Methylation Markers for Cancer Screening
1 other identifier
interventional
15,000
1 country
1
Brief Summary
The purpose of this study is to evaluate the role of cell-free DNA methylation markers in cancer screening.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2017
CompletedFirst Posted
Study publicly available on registry
March 30, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedDecember 27, 2017
December 1, 2017
3.3 years
March 15, 2017
December 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
sensitivity (true positive rate)
The proportion of persons with disease who have a positive test (positive test results among persons with disease)
2 year
Specificity (true negative rate)
The proportion of persons without disease who have a negative test (negative test results among persons without disease)
2 year
Study Arms (2)
Normal screening group
PLACEBO COMPARATORpatients receive the routine screening examination
methylation markers screening group
EXPERIMENTALpatients receive the methylation markers screening
Interventions
Cell-free DNA extraction from plasma samples-Bisulfite conversion of cfDNA-Determination of DNA methylation levels by deep sequencing-Sequencing data analysis
Eligibility Criteria
You may qualify if:
- Subject is average risk for development of cancer
- Subject able and willing to undergo screening test within 90 days of enrollment
- Subject is 40 to 74 years of age inclusive
- Subject is able to comprehend, sign, and date the written informed consent document to participate in the study
You may not qualify if:
- Subject has any condition which, in the opinion of the investigator should preclude participation in the study
- Subject has a history of cancer
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Related 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.
PMID: 24645800RESULT
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
March 15, 2017
First Posted
March 30, 2017
Study Start
June 1, 2017
Primary Completion
October 1, 2020
Study Completion
May 1, 2021
Last Updated
December 27, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share