Blood test for detecting liver cancer and cirrhosis
Collection of Blood to Evaluate Epigenomics and Protein Biomarkers for the Detection of Hepatocellular Carcinoma
This study is testing a new blood test to see if it can help detect liver cancer and cirrhosis in people who have or are being checked for liver issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Helio Genomics Industry-sponsored |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 7 sites (Mission Hills, California and 6 other locations) |
| Trial ID | NCT05199259 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect whole blood and serum samples from participants with untreated Hepatocellular Carcinoma (HCC) and those undergoing HCC surveillance. Participants will be divided into two main groups: those diagnosed with HCC and those without. The latter group will be further categorized based on the imaging methods used to confirm the absence of HCC. The collected samples will be utilized to develop and validate the Helio multi-analyte blood test for better detection of liver conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with cirrhosis or those meeting guidelines for HCC surveillance.
Not a fit: Patients who do not have liver disease or are not at risk for HCC may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of liver cancer, potentially enhancing treatment outcomes for patients.
How similar studies have performed: Other studies have shown promise in using multi-analyte blood tests for cancer detection, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older. * Males and Females. * Having cirrhosis or meeting the AASLD guidelines for HCC * surveillance. * Clinically diagnosed with HCC or negative for HCC following disease * surveillance. * HCC positive Group: Subject has a recent (within 6 months of enrollment) clinically diagnosed, untreated hepatocellular carcinoma as defined by at least one ≥1 cm lesion exhibiting arterial phase hyperenhancement in combination with washout appearance and/or capsule by 4 phase CT scan or multiphase contrast enhanced MRI or biopsy is positive for HCC. * HCC negative Group: Non-cancer, at-risk subjects with chronic liver disease undergoing routine imaging surveillance for HCC, where the definitive lack of HCC within 3 months prior to enrollment has been verified by negative imaging, for HCC. No more than 200 subjects without cirrhosis can be enrolled in this group. * Sub-Group 1 (approximately 450 subjects) - negative by CT or MRI (No lesion, LR-1 or LR-2) * Sub-Group 2 (approximately 450 subjects) - negative by ultrasound Exclusion Criteria: * Subjects that are unwilling or unable to sign the Informed Consent Form will be excluded. * Known cancer diagnosis of a cancer other than HCC within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers). * Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection. * Prior or current treatment with sorafenib, regorafenib, or other treatment indicated for HCC. * Prior treatment with a DNA methyltransferase inhibitor such as with Vidaza (azacitidine) or Dacogen (decitabine) * Any HCC treatment prior to enrollment/blood sample collection (e.g., surgery, ablation, embolization, pharmacotherapy, radiotherapy, liver transplant or other treatment indicated for HCC). * IV contrast (e.g., CT and MRI) within 1 day \[or 24 hours\] of blood collection. * Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection. * Less than 7 days between biopsy (other than FNA) of target pathology and blood collection. * Any condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk. * For HCC negative subjects, patients with a prior diagnosis of HCC are also excluded. * Subjects that are pregnant will be exclude
Where this trial is running
Mission Hills, California and 6 other locations
- Providence Facey Medical Foundation — Mission Hills, California, United States (Recruiting)
- Guardian Angel Research Center — Tampa, Florida, United States (Recruiting)
- GI Research Mercy Medical Center — Baltimore, Maryland, United States (Recruiting)
- South Texas Research Institute — Edinburg, Texas, United States (Recruiting)
- Texas Gastro Research — El Paso, Texas, United States (Recruiting)
- Impact Research Institute — Waco, Texas, United States (Recruiting)
- Digestive & Liver Disease Specialist — Norfolk, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Operations Manager, BSN, RN
- Email: octavia@heliogenomics.com
- Phone: 626-350-0537
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.