Actively Recruiting
Multi-analyte Blood Test Clinical Trial
Led by Helio Genomics · Updated on 2024-06-14
1200
Participants Needed
7
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 (HCC) surveillance. These samples will be used for research purposes to develop and validate the Helio multi-analyte blood test.
CONDITIONS
Official Title
Multi-analyte Blood Test Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older.
- Males and females.
- Having cirrhosis or meeting the AASLD guidelines for HCC surveillance.
- Clinically diagnosed with HCC or confirmed negative for HCC after disease surveillance.
- For HCC positive group: recent (within 6 months) clinically diagnosed, untreated hepatocellular carcinoma defined by imaging or biopsy.
- For HCC negative group: chronic liver disease patients with no HCC confirmed by imaging within 3 months prior to enrollment.
- Sub-group 1: negative by CT or MRI (No lesion, LR-1 or LR-2).
- Sub-group 2: negative by ultrasound.
You will not qualify if you...
- Unable or unwilling to sign the Informed Consent Form.
- Diagnosis of cancer other than HCC within the past 5 years (except basal or squamous cell skin cancers).
- Chemotherapy or radiation therapy within 5 years prior to enrollment.
- Prior or current treatment with sorafenib, regorafenib, or other HCC treatments.
- Prior treatment with DNA methyltransferase inhibitors such as Vidaza or Dacogen.
- Any HCC treatment before enrollment or blood collection (including surgery, ablation, embolization, pharmacotherapy, radiotherapy, liver transplant).
- IV contrast imaging (CT or MRI) within 24 hours of blood collection.
- Less than 3 days between fine needle aspiration of target pathology and blood collection.
- Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
- Any condition that interferes with consent, protocol compliance, study interpretation, or increases risk.
- For HCC negative subjects, prior diagnosis of HCC.
- Pregnancy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Providence Facey Medical Foundation
Mission Hills, California, United States, 91345
Actively Recruiting
2
Guardian Angel Research Center
Tampa, Florida, United States, 33614
Actively Recruiting
3
GI Research Mercy Medical Center
Baltimore, Maryland, United States, 21202
Actively Recruiting
4
South Texas Research Institute
Edinburg, Texas, United States, 78539
Actively Recruiting
5
Texas Gastro Research
El Paso, Texas, United States, 79936
Actively Recruiting
6
Impact Research Institute
Waco, Texas, United States, 76710
Actively Recruiting
7
Digestive & Liver Disease Specialist
Norfolk, Virginia, United States, 23502
Actively Recruiting
Research Team
C
Clinical Operations Manager, BSN, RN
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here