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Multi-analyte Blood Test Clinical Trial

ConditionsLiver CirrhosisLiver CancerHCCHepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHelio Genomics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older.

Males and Females.

Having cirrhosis or meeting the AASLD guidelines for HCC

surveillance.

Disqualifiers

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.

Trial population

The subjects will fall into two main groups, subjects diagnosed with HCC (HCC positive Group) or subjects without HCC (HCC negative Group). The HCC negative Group will be further divided into two sub-groups based on whether the absence of HCC has been determined using CT or MRI procedures (Sub-group 1) or ultrasound (Sub-group 2). Only the subjects in sub-group 2 will receive a confirmatory ultrasound approximately 6 months (between 5 to 7 months) after enrollment to confirm the absence of HCC ("6-month visit). This additional imaging study is necessary due to the low sensitivity of abdominal ultrasound to detect HCC lesions. The blood specimens will be shipped to a clinical diagnostic laborator

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Multi-analyte Blood Test

    Diagnostic test

    A clinical diagnostic test based upon the detection and quantification of DNA methylation markers in cell-free DNA (cfDNA) isolated from plasma and of tumor-specific proteins isolated from serum.

Treatment groups

1,200 Participants
are divided into 3 treatment groups
Group A: HCC positive Group1 intervention
Group B: HCC negative Group: Sub-Group 11 intervention
Group C: HCC negative Group: Sub-Group 21 intervention

Trial outcomes

Primary outcomes

1

Independent performance measure of sensitivity and specificity of a multi-analyte blood test

The primary objective is to measure the performance (sensitivity and specificity) the multi-analyte blood Test for the detection of liver cancers in high-risk particiapnats.

Time frame
1 - 9 months

Secondary outcomes

1

To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test

To investigate potential endogenous and exogenous interfering substances of a multi-analyte blood test for the detection of liver cancers within healthy subjects, subjects diagnosed with active cancer, subjects in cancer remission, and subjects diagnosed with a benign disease.

Time frame
1 - 9 months
2

Ascertain Reference Range(s)

Ascertain reference range determination(s) for select CpG methylation sites

Time frame
1 - 9 months
3

Ascertain Sample Stability

Sample stability under various shipping conditions

Time frame
1 - 9 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Helio Genomics

Lead sponsor

Source ClinicalTrials.gov
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