Cancer Screening
Conditions
Keywords
cell-free DNA, methylation, markers, cancer, screening
Brief summary
The purpose of this study is to evaluate the role of cell-free DNA methylation markers in cancer screening.
Interventions
DIAGNOSTIC_TESTmethylation markers screening
Cell-free DNA extraction from plasma samples-Bisulfite conversion of cfDNA-Determination of DNA methylation levels by deep sequencing-Sequencing data analysis
Sponsors
Sun Yat-sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 74 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Outcome results
None listed