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Multi-analyte Blood Test Clinical Trial (LIVER-1 Trial)
Mission Hills, CA
N/A
Recruiting
Research Sponsored by Laboratory for Advanced Medicine, Indiana
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 - 9 months
Awards & highlights
No Placebo-Only Group
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 (HCC) surveillance. These samples will be used for research purposes to develop and validate the Helio multi-analyte blood test.
See full description
Eligible Conditions
- Liver Cirrhosis
- Hepatocellular Carcinoma
- Liver Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 - 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 - 9 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Independent performance measure of sensitivity and specificity of a multi-analyte blood test
Secondary study objectives
Ascertain Reference Range(s)
Ascertain Sample Stability
To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: HCC positive GroupExperimental Treatment1 Intervention
Multi-analyte blood test screen in participants with a recent confirmed untreated diagnosis of HCC by CT scan, MRI or biopsy.
Group II: HCC negative Group: Sub-Group 2Experimental Treatment1 Intervention
Multi-analyte blood test screen in participants with a recent confirmed negative diagnosis of HCC by ultrasound. Participants will be scheduled for a 6 month visit (at least 5 months but no more 9 months form enrollment) for a confirmatory ultrasound.
Group III: HCC negative Group: Sub-Group 1Experimental Treatment1 Intervention
Multi-analyte blood test screen in participants with a recent confirmed negative diagnosis of HCC by CT or MRI (No lesion, LR-1 or LR-2)
Find a Location
Closest Location:Impact Research Institute· Waco, TX· 432 miles
Who is running the clinical trial?
Laboratory for Advanced Medicine, IndianaLead Sponsor
4 Previous Clinical Trials
4,946 Total Patients Enrolled
2 Trials studying Liver Cirrhosis
3,100 Patients Enrolled for Liver Cirrhosis
Helio GenomicsLead Sponsor
4 Previous Clinical Trials
4,946 Total Patients Enrolled
2 Trials studying Liver Cirrhosis
3,100 Patients Enrolled for Liver Cirrhosis
TaggertStudy DirectorHelio Health
1 Previous Clinical Trials
1,200 Total Patients Enrolled
1 Trials studying Liver Cirrhosis
1,200 Patients Enrolled for Liver Cirrhosis
Kisha BushStudy DirectorHelio Health
2 Previous Clinical Trials
3,100 Total Patients Enrolled
2 Trials studying Liver Cirrhosis
3,100 Patients Enrolled for Liver Cirrhosis
BushStudy DirectorHelio Health
1 Previous Clinical Trials
1,200 Total Patients Enrolled
1 Trials studying Liver Cirrhosis
1,200 Patients Enrolled for Liver Cirrhosis