Abbreviated Name

HEDS Ref Set - UTSW Data Only

Lead Investigator

Singal, Amit — UT Southwestern Medical Center

Coordinating Investigator

Zheng, Yingye — Fred Hutchinson Cancer Center

Involved Investigators

• Singal, Amit — UT Southwestern Medical Center
• Zheng, Yingye — Fred Hutchinson Cancer Center

Abstract

Methods 1.   We propose to look at baseline clinical risk scores (aMAP and THRI) in the full HEDS cohort with data for both scores (i.e., patients with data for one score but not the other will be exclude). These scores can be derived using baseline clinical data, with thresholds for risk categories (low, medium, and high) based on published cut-offs for each risk score [aMAP - Low:  50 ; Intermediate: (>50 – < 60) ; High:  60. Toronto HCC Risk Index - Low: < 120; Intermediate: (120 – 240); High: > 240]. 2.   We will report the positive predictive value (PPV) and sensitivity of baseline high-risk aMAP and baseline high-risk THRI as well as negative predictive value (NPV) and specificity of low-risk aMAP and THRI. 3.   We will examine changes in aMAP and THRI scores using baseline and follow-up data during one-year period. 4.   We will describe how many patients with incident HCC (after 1 year period) and how many without HCC change risk categories [low to intermediate, low to high, intermediate to high, intermediate to low, high to intermediate, and high to low]. Patients with incident HCC within one year of baseline will be excluded from this analysis. 5.   Data from #4 should enable calculation of PPV, NPV, sensitivity, and specificity of increases and decreases in aMAP and THRI categories.

Aims

Methods 1.   We propose to look at baseline clinical risk scores (aMAP and THRI) in the full HEDS cohort with data for both scores (i.e., patients with data for one score but not the other will be exclude). These scores can be derived using baseline clinical data, with thresholds for risk categories (low, medium, and high) based on published cut-offs for each risk score [aMAP - Low:  50 ; Intermediate: (>50 – < 60) ; High:  60. Toronto HCC Risk Index - Low: < 120; Intermediate: (120 – 240); High: > 240]. 2.   We will report the positive predictive value (PPV) and sensitivity of baseline high-risk aMAP and baseline high-risk THRI as well as negative predictive value (NPV) and specificity of low-risk aMAP and THRI. 3.   We will examine changes in aMAP and THRI scores using baseline and follow-up data during one-year period. 4.   We will describe how many patients with incident HCC (after 1 year period) and how many without HCC change risk categories [low to intermediate, low to high, intermediate to high, intermediate to low, high to intermediate, and high to low]. Patients with incident HCC within one year of baseline will be excluded from this analysis. 5.   Data from #4 should enable calculation of PPV, NPV, sensitivity, and specificity of increases and decreases in aMAP and THRI categories.

Analytic Method

Analysis Plan 1.   We will report the positive predictive value (PPV) and sensitivity of baseline high-risk aMAP and baseline high-risk THRI as well as negative predictive value (NPV) and specificity of low-risk aMAP and THRI. 2.   We will describe how many patients with incident HCC (after 1 year period) and how many without HCC change risk categories [low to intermediate, low to high, intermediate to high, intermediate to low, high to intermediate, and high to low]. Patients with incident HCC within one year of baseline will be excluded from this analysis.

Outcome

Methods 1.   We propose to look at baseline clinical risk scores (aMAP and THRI) in the full HEDS cohort with data for both scores (i.e., patients with data for one score but not the other will be exclude). These scores can be derived using baseline clinical data, with thresholds for risk categories (low, medium, and high) based on published cut-offs for each risk score [aMAP - Low:  50 ; Intermediate: (>50 – < 60) ; High:  60. Toronto HCC Risk Index - Low: < 120; Intermediate: (120 – 240); High: > 240]. 2.   We will report the positive predictive value (PPV) and sensitivity of baseline high-risk aMAP and baseline high-risk THRI as well as negative predictive value (NPV) and specificity of low-risk aMAP and THRI. 3.   We will examine changes in aMAP and THRI scores using baseline and follow-up data during one-year period. 4.   We will describe how many patients with incident HCC (after 1 year period) and how many without HCC change risk categories [low to intermediate, low to high, intermediate to high, intermediate to low, high to intermediate, and high to low]. Patients with incident HCC within one year of baseline will be excluded from this analysis. 5.   Data from #4 should enable calculation of PPV, NPV, sensitivity, and specificity of increases and decreases in aMAP and THRI categories.

Publications

• No publications available at this time for this protocol.

Biomarkers

• No biomarkers available at this time for this protocol.

Data Collections

• No data collections available at this time for this protocol.

 Team Project

Finish Date

Jun 2 2026

Protocol ID

589

Protocol Type

Reference Set

Fields of Research

• Glycomics
• Proteomics

Collaborative Group

G.I. and Other Associated Cancers Research Group

Cancer Types

• Liver cell carcinoma