Hepatocellular carcinoma Early Detection Strategy study
- 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
- Diaz-Mayoral, Norma — Frederick National Laboratory for Cancer Research
- Srivastava, Sudhir — National Cancer Institute
- Zheng, Yingye — Fred Hutchinson Cancer Center
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
TBD
Outcome
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.
Publications
- No publications available at this time for this protocol.
Biomarkers
Data Collections
- No data collections available at this time for this protocol.
- Start Date
- Sep 1 2009
- Estimated Finish Date
- Aug 31 2014
- 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