Abbreviated Name

HEDS

Lead Investigator

Marrero, Jorge — University of Pennsylvania

Coordinating Investigator

Zheng, Yingye — Fred Hutchinson Cancer Center

Involved Investigators

• Winick, Jeffrey — Wako Diagnostics/Fujifilm
• Schwartz, Myron — Mount Sinai Hospital
• Marrero, Jorge — University of Pennsylvania
• Singal, Amit — UT Southwestern Medical Center
• Befeler, Alex — Saint Louis University
• Roberts, Lewis — Mayo Clinic
• Nguyen, Mindie — Stanford University
• Parikh, Neehar — University of Michigan
• Hutchinson, Amy — Frederick National Laboratory for Cancer Research
• Srivastava, Sudhir — National Cancer Institute
• Zheng, Yingye — Fred Hutchinson Cancer Center
• Reddy, Rajender — University of Pennsylvania

Abstract

Part 1: The first part of this study is to conduct follow-up for patients that were enrolled in the EDRN Phase 2 Validation Study called DCP (13). For this part of the study, four groups are defined as follows: a)   Vanguard Controls are cirrhotic controls, from the Phase 2 trial that have not developed HCC and sign a new consent form for HEDS participation. These patients will be followed for a minimum of an additional 24 months and have biospecimens collected every 6 months. b)   Vanguard Interval Controls are cirrhotic controls, from the Phase 2 trial that have not developed HCC and do not sign a new consent form for HEDS participation. This group will have outcome data abstracted from their medical records. c)   Vanguard Interval Cases are cirrhotic controls from the Phase 2 trial that developed HCC after completion of the Phase 2 trial but prior to the current study. This group will have outcome data abstracted from their medical records. d)   Vanguard Cases are HCC cases from the Phase 2 trial. This group will have outcome data abstracted from their medical records. Part 2: New Controls - The second part of this study is the new accrual of cirrhotic controls at the seven participating sites. These patients will be followed for a minimum of 24 months and have biospecimens collected every 6 months. Data will be collected every 6 months: ultrasound, AFP, liver function tests, complete blood counts, MELD scores and any changes in medical history, personal cancer history and family cancer history.

Aims

The Specific Aims of the HEDS study are: Aim 1:   (a) To determine the incidence rate and the performance of ultrasound, and the biomarkers, alpha-fetoprotein (AFP), AFP-L3%, and des-gamma carboxy-prothrombin (DCP), in detecting preclinical hepatocellular carcinoma (HCC). (b) To evaluate the performance of novel biomarkers for the detection of preclinical HCC. Aim 2:   To determine the cost-effectiveness of surveillance strategies for HCC. Aim 3:   To determine the performance of biomarkers in the prognosis of patients with HCC. Aim 4:   To establish a biorepository of longitudinally collected biospecimens from this cohort of cirrhotic patients. These biospecimens will form a reference set to be used for future EDRN biomarker validation research.

Analytic Method

Analyzed by DMCC

Comments

No comments available.

Outcome

See manuscript

Secure Outcome

No secure outcome available.

Publications

• A Phase 3 Biomarker Validation of GALAD for the Detection of Hepatocellular Carcinoma in Cirrhosis.

Biomarkers

• DCP and AFP-L3, and GALAD score - risk biomarkers for HCC (Panel)

Data Collections

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

Start Date

Sep 1 2009

Estimated Finish Date

Aug 31 2014

Finish Date

Jan 6 2026

Protocol ID

316

Protocol Type

Validation

Fields of Research

• Glycomics
• Proteomics

Collaborative Group

G.I. and Other Associated Cancers Research Group

Cancer Types

• Liver cell carcinoma

Phased Status

3