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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-analyte Blood Test | Diagnostic Test | Intend for the qualitative detection of DNA methylation markers for the detection of various types of cancer |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 Month |
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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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations Manager | Contact | 6263500537 | octavia@heliogenomics.com |
| Name | Affiliation | Role |
|---|---|---|
| Taggert | Helio Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Torrance Memorial Physician Network - Cancer Care | Active, not recruiting | Redondo Beach | California | 90277 | United States |
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| Ascertain Reference Range(s) | Ascertain reference range determination(s) for select CpG methylation sites | 1 Month |
| Ascertain Sample Stability | Sample stability under various shipping conditions | 1 Month |
| Allina Health, Virginia Piper Cancer Institute | Recruiting | Coon Rapids | Minnesota | 55433 | United States |
|
| Virginia Piper Cancer Institute Mercy Hospital-Unity Campus | Recruiting | Fridley | Minnesota | 55432 | United States |
|
| VPCI Oncology Research | Recruiting | Minneapolis | Minnesota | 55407 | United States |
|
| Methodist LeBonheur Healthcare | Recruiting | Memphis | Tennessee | 38104 | United States |
|
| Liver Center of Texas | Recruiting | Dallas | Texas | 75234 | United States |
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| Methodist Hospital | Recruiting | Richardson | Texas | 75082 | United States |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008103 | Liver Cirrhosis |
| D006521 | Hepatitis, Chronic |
| D006509 | Hepatitis B |
| D006526 | Hepatitis C |
| D003920 | Diabetes Mellitus |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006505 | Hepatitis |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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