Cancer, Chronic Hepatitis, COPD, Diabetes, Hepatitis B, Hepatitis C, Liver Cirrhosis
Conditions
Brief summary
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.
Detailed description
Whole blood, plasma, and/or serum specimens will be collected from patients with active cancer, patients in cancer remission, patients diagnosed with benign disease, and healthy volunteers. These blood samples will be used to perform various studies to determine the utility of select DNA methylation markers for cancer diagnostic or prognostic indications.
Interventions
DIAGNOSTIC_TESTMulti-analyte Blood Test
Intend for the qualitative detection of DNA methylation markers for the detection of various types of cancer
Sponsors
Helio Genomics
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
2.1.1 Age 18 years or older. 2.1.2 A diagnosis of cancer, cancer remission, benign disease (benign tumor, diabetes, liver cirrhosis, chronic hepatitis B or hepatitis C virus infection, Chronic obstructive pulmonary disease, etc.) or apparently healthy volunteers. .
Exclusion criteria
2.2.1 Patients that are unwilling or unable to sign the Informed Consent Form will be excluded. 2.2.2 Approximately 50 mL of blood will be drawn from participants within an 8-week period under this protocol. Patients that have already given 50 mL of blood within this time frame will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Independent performance measure of sensitivity and specificity of a multi-analyte blood test | 1 month | 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
| Measure | Time frame | Description |
|---|---|---|
| To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test | 1 Month | 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) | 1 Month | Ascertain reference range determination(s) for select CpG methylation sites |
| Ascertain Sample Stability | 1 Month | Sample stability under various shipping conditions |
Countries
United States
Contacts
CONTACTClinical Operations Manager
STUDY_DIRECTORTaggert
Helio Health
Outcome results
None listed