Collection of Blood From Healthy Patients, Patients With Benign Disease and Patients With Cancer
Collection of Blood From Healthy Patients, Patients With Benign Disease and Patients With Cancer
Sponsors
Source
Helio Genomics
Oversight Info
Is Fda Regulated Drug
No
Is Fda Regulated Device
Yes
Is Unapproved Device
Yes
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.
Overall Status
Recruiting
Start Date
2019-05-21
Completion Date
2025-12-01
Primary Completion Date
2025-09-01
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
Independent performance measure of sensitivity and specificity of a multi-analyte blood test |
1 month |
Secondary Outcome
Measure |
Time Frame |
|
To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test |
1 Month |
|
Ascertain Reference Range(s) |
1 Month |
|
Ascertain Sample Stability |
1 Month |
Enrollment
1200
Conditions
Intervention
Intervention Type
Diagnostic Test
Intervention Name
Description
Intend for the qualitative detection of DNA methylation markers for the detection of
various types of cancer
Eligibility
Study Pop
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.
Sampling Method
Non-Probability Sample
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.
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Overall Official
Last Name |
Role |
Affiliation |
|
Taggert |
Study Director |
Helio Health |
Overall Contact
Last Name
Clinical Operations Manager
Phone
6263500537
octavia@heliogenomics.com
Location
Facility |
Status | ||
|
Torrance Memorial Physician Network - Cancer Care Redondo Beach 5386785 California 5332921 90277 United States |
Active, not recruiting | ||
|
Allina Health, Virginia Piper Cancer Institute Coon Rapids 5022025 Minnesota 5037779 55433 United States |
Recruiting |
Last Name: Kathryn Gruetzman Phone: 763-236-0814 Email: kathryn.gruetzman@allina.com |
Last Name: Micheala Tsai, MD Role: Principal Investigator |
|
Virginia Piper Cancer Institute Mercy Hospital-Unity Campus Fridley 5027482 Minnesota 5037779 55432 United States |
Recruiting |
Last Name: Lynne Schroeder Email: lynne.schroeder@allina.com |
Last Name: Micheala Tsai Role: Principal Investigator |
|
VPCI Oncology Research Minneapolis 5037649 Minnesota 5037779 55407 United States |
Recruiting |
Last Name: Kelsey Froemming Email: kelsey.froemming@allina.com |
Last Name: Micheala Tsai, MD Role: Principal Investigator |
|
Methodist LeBonheur Healthcare Memphis 4641239 Tennessee 4662168 38104 United States |
Recruiting |
Last Name: Carol Jones Phone: 901-516-8078 Email: carol.jones@mlh.org |
Last Name: Jiten Kothadia, MD Role: Principal Investigator |
|
Liver Center of Texas Dallas 4684888 Texas 4736286 75234 United States |
Recruiting |
Last Name: Ariela Moreno Email: ariela@livercenteroftexas.com |
Last Name: Abdullah Mubarak, MD Role: Principal Investigator |
|
Methodist Hospital Richardson 4722625 Texas 4736286 75082 United States |
Recruiting |
Last Name: Araceli Torres Email: aracelitorres@mhd.com |
Last Name: Rohan Jeyarajah, MD Role: Principal Investigator |
Location Countries
Country
United States
Verification Date
2023-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Condition Browse
Firstreceived Results Date
N/A
Acronym
ELITE
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Other
Time Perspective
Prospective
Study First Submitted
December 17, 2021
Study First Submitted Qc
January 5, 2022
Study First Posted
January 6, 2022
Last Update Submitted
June 13, 2024
Last Update Submitted Qc
June 13, 2024
Last Update Posted
June 14, 2024
ClinicalTrials.gov processed this data on October 31, 2025
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.