CancerELITENCT05181826
Collection of Blood From Healthy Patients, Patients With Benign Disease and Patients With Cancer
An observational study of Cancer and Liver Cirrhosis, run by Helio Genomics at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Liver Cirrhosis, Chronic Hepatitis
- What is being tested?
- Multi-analyte Blood Test
- How many people
- 1,200 participants
- Where
- 7 sitesUnited States
- Study dates
- 21 May 2019to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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. .
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 6 recruiting
- Recruiting
Allina Health, Virginia Piper Cancer Institute
Coon Rapids, Minnesota, 55433
Kathryn Gruetzman, 763-236-0814, kathryn.gruetzman@allina.com
Micheala Tsai, MD
- Recruiting
Liver Center of Texas
Dallas, Texas, 75234
Ariela Moreno, ariela@livercenteroftexas.com
Abdullah Mubarak, MD
- Recruiting
Virginia Piper Cancer Institute Mercy Hospital-Unity Campus
Fridley, Minnesota, 55432
Lynne Schroeder, lynne.schroeder@allina.com
Micheala Tsai
- Recruiting
Methodist LeBonheur Healthcare
Memphis, Tennessee, 38104
Carol Jones, 901-516-8078, carol.jones@mlh.org
Jiten Kothadia, MD
- Recruiting
VPCI Oncology Research
Minneapolis, Minnesota, 55407
Kelsey Froemming, kelsey.froemming@allina.com
Micheala Tsai, MD
- Active, not recruiting
Torrance Memorial Physician Network - Cancer Care
Redondo Beach, California, 90277
- Recruiting
Methodist Hospital
Richardson, Texas, 75082
Araceli Torres, aracelitorres@mhd.com
Rohan Jeyarajah, MD
About this study
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.
Read the 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.
- Conditions
- Cancer, Liver Cirrhosis, Chronic Hepatitis, Hepatitis B, Hepatitis C, Diabetes
- Being tested
- Multi-analyte Blood Test
- Medical subject headings
- Neoplasms, Liver Cirrhosis, Hepatitis, Chronic, Hepatitis B, Hepatitis C, Diabetes Mellitus, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-analyte Blood TestDiagnostic test
Intend for the qualitative detection of DNA methylation markers for the detection of various types of cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (3)
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.
Measured: 1 Month
Ascertain Reference Range(s)
Ascertain reference range determination(s) for select CpG methylation sites
Measured: 1 Month
Ascertain Sample Stability
Sample stability under various shipping conditions
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start21 May 2019
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helio Genomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taggert, Study director, Helio Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181826
- Sponsor's protocol ID
- 001-2018
- Acronym
- ELITE
- Status last verified
- Jul 2026
- First submitted
- 17 Dec 2021
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Blood From Healthy Patients, Patients With Benign Disease and Patients With Cancer
- ClinicalTrials.gov ID
- NCT05181826
- Acronym / sponsor ID
- ELITE / 001-2018
- Conditions
- Cancer, Liver Cirrhosis, Chronic Hepatitis, Hepatitis B, Hepatitis C, Diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Helio GenomicsIndustry (pharma, biotech, devices)
- Study start
- 21 May 2019 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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. .
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-analyte Blood TestIntend for the qualitative detection of DNA methylation markers for the detection of various types of cancer | Diagnostic test | – |
Primary outcome
Independent performance measure of sensitivity and specificity of a multi-analyte blood test
Time frame: 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.
3 secondary outcomes
To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test
Time frame: 1 Month
Ascertain Reference Range(s)
Time frame: 1 Month
Ascertain Sample Stability
Time frame: 1 Month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taggert study director
Helio Health
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Liver Cirrhosis, run by Helio Genomics at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations Manager (6263500537, octavia@heliogenomics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Independent performance measure of sensitivity and specificity of a multi-analyte blood test (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.