About this trial
To acquire blood samples from subjects for various purposes, including: i) determining the sensitivity and specificity of select DNA methylation markers for the detection of various types of cancer, ii) identifying benign conditions that may induce false positive or false negative results, and iii) defining the effects of potential interfering substances, such as chemotherapy drugs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Healthy subjects, subjects diagnosed with active cancer, subjects in cancer remission, and subjects diagnosed with a benign disease will eligible to participate in this study.
Trial design
Other
Prospective
Treatments tested in this trial
Multi-analyte Blood Test
Diagnostic testIntend for the qualitative detection of DNA methylation markers for the detection of various types of cancer
Treatment groups
Trial outcomes
Primary outcomes
Independent performance measure of sensitivity and specificity of a multi-analyte blood test
The primary objective is to measure the performance (sensitivity and specificity) the multi-analyte blood Test for the detection of liver cancers in healthy subjects, subjects diagnosed with active cancer, subjects in cancer remission, and subjects diagnosed with a benign disease.
Secondary outcomes
To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test
To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test for the detection of liver cancers within healthy subjects, subjects diagnosed with active cancer, subjects in cancer remission, and subjects diagnosed with a benign disease.
Ascertain Reference Range(s)
Ascertain reference range determination(s) for select CpG methylation sites
Ascertain Sample Stability
Sample stability under various shipping conditions
Sponsors and contacts
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