Clinical trial NCT05181826: Collection of Blood From Healthy Patients, Patients With Benign Disease and Patients With Cancer
Official title: Collection of Blood From Healthy Patients, Patients With Benign Disease and Patients With Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Liver Cirrhosis
Chronic Hepatitis
Hepatitis B
Hepatitis C
Diabetes
COPD
Lead sponsor: Helio Genomics
Sponsor class: INDUSTRY
First posted: 2022-01-06
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Independent performance measure of sensitivity and specificity of a multi-analyte blood test
timeFrame: 1 month
Secondary outcomes:
measure: To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test
timeFrame: 1 Month
measure: Ascertain Reference Range(s)
timeFrame: 1 Month
measure: Ascertain Sample Stability
timeFrame: 1 Month
Other outcomes:
Locations:
city: Redondo Beach
country: United States
facility: Torrance Memorial Physician Network - Cancer Care
state: California
city: Coon Rapids
country: United States
facility: Allina Health, Virginia Piper Cancer Institute
state: Minnesota
city: Fridley
country: United States
facility: Virginia Piper Cancer Institute Mercy Hospital-Unity Campus
state: Minnesota
city: Minneapolis
country: United States
facility: VPCI Oncology Research
state: Minnesota
city: Memphis
country: United States
facility: Methodist LeBonheur Healthcare
state: Tennessee
city: Dallas
country: United States
facility: Liver Center of Texas
state: Texas
city: Richardson
country: United States
facility: Methodist Hospital
state: Texas
Study officials:
affiliation: Helio Health
name: Taggert
role: STUDY_DIRECTOR
References: