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Multi-analyte Blood Test Clinical Trial (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

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.

Eligible Conditions

Non-invasive Indices to Predict Hepatic Fibrosis in BA Patients.
Liver Cancer
Hepatocellular Carcinoma
Liver Cirrhosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 - 9 months

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

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)

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