Blood test for detecting liver cancer and cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Gastroenterology and Liver Institute
  Escondido, California, United States Recruiting
• Providence Facey Medical Foundation
  Mission Hills, California, United States Recruiting
• UF Hepatology Research at CTRB
  Gainesville, Florida, United States Recruiting
• Guardian Angel Research Center
  Tampa, Florida, United States Recruiting
• South Texas Research Institute
  Edinburg, Texas, United States Recruiting
• Texas Gastro Research
  El Paso, Texas, United States Recruiting

Study contacts

• Study coordinator: Clinical Operations Manager, BSN, RN
• Email: octavia@heliogenomics.com
• Phone: 626-350-0537

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.