Collection of Blood From Healthy Patients, Patients With Benign Disease and Patients With Cancer (ELITE)

• ClinicalTrials.gov Identifier: NCT05181826
• Recruitment Status: Recruiting
• First Posted: January 6, 2022
• Last Update Posted: July 11, 2023
• Sponsor: Helio Genomics
• Information provided by (Responsible Party): Helio Genomics

Tracking Information

• First Submitted Date: December 17, 2021
• First Posted Date: January 6, 2022
• Last Update Posted Date: July 11, 2023
• Actual Study Start Date: May 21, 2019
• Estimated Primary Completion Date: September 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 5, 2022)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 5, 2022)

• To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test [ Time Frame: 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) [ Time Frame: 1 Month ]
  Ascertain reference range determination(s) for select CpG methylation sites
• Ascertain Sample Stability [ Time Frame: 1 Month ]
  Sample stability under various shipping conditions

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Cancer
• Liver Cirrhosis
• Chronic Hepatitis
• Hepatitis B
• Hepatitis C
• Diabetes
• COPD

Intervention

Diagnostic Test: Multi-analyte Blood Test

Intend for the qualitative detection of DNA methylation markers for the detection of various types of cancer

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 5, 2022): 1200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2023
• Estimated Primary Completion Date: September 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided

Contacts

Contact: Clinical Operations Manager; 6263500537; octavia@heliogenomics.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05181826
• Other Study ID Numbers: 001-2018
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Helio Genomics
• Original Responsible Party: Same as current
• Current Study Sponsor: Helio Genomics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Taggert; Helio Health

• PRS Account: Helio Genomics
• Verification Date: July 2023