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HCC positive Group for Liver Cancer (LIVER-1 Trial)

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

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.

Eligible Conditions
  • Liver Cancer
  • Hepatocellular Carcinoma
  • Liver Cirrhosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 - 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 - 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Independent performance measure of sensitivity and specificity of a multi-analyte blood test
Secondary outcome measures
Ascertain Reference Range(s)
Ascertain Sample Stability
To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test

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

Who is running the clinical trial?

Laboratory for Advanced Medicine, IndianaLead Sponsor
4 Previous Clinical Trials
4,390 Total Patients Enrolled
Helio GenomicsLead Sponsor
4 Previous Clinical Trials
4,390 Total Patients Enrolled
Kisha BushStudy DirectorHelio Health
2 Previous Clinical Trials
3,100 Total Patients Enrolled
~106 spots leftby Jan 2025
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