Status:
RECRUITING
Multi-analyte Blood Test Clinical Trial
Lead Sponsor:
Helio Genomics
Conditions:
Liver Cirrhosis
Liver Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study is the acquisition of whole blood samples and serum samples from participants with untreated Hepatocellular Carcinoma (HCC) and subjects undergoing Hepatocellular Carcinoma...
Detailed Description
This study pertains to the collection of whole blood and serum specimens from participants undergoing Hepatocellular Carcinoma (HCC) surveillance. The participants will fall into two main groups, subj...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT05199259
Start Date
March 1 2022
End Date
March 1 2025
Last Update
June 14 2024
Active Locations (7)
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1
Providence Facey Medical Foundation
Mission Hills, California, United States, 91345
2
Guardian Angel Research Center
Tampa, Florida, United States, 33614
3
GI Research Mercy Medical Center
Baltimore, Maryland, United States, 21202
4
South Texas Research Institute
Edinburg, Texas, United States, 78539