Skip to content. | Skip to navigation

National Cancer Institute U.S. National Institutes of Health www.cancer.gov

Navigation

Personal tools

You are here: Home / Protocols / Hepatocellular carcinoma Early Detection Strategy study

Hepatocellular carcinoma Early Detection Strategy study

316

No involved investigator sites defined.

Biomarkers that pass the test on the HCC Phase 2 Validation Set will be included in the Phase 3 study. These makers, along with DCP, will not be measured in real time, but will be assayed retrospectively in a blinded fashion either from samples collected from the entire prospective cohort or from a nested case-control sample embedded in the whole cohort.
Glycomics
Proteomics
G.I. and Other Associated Cancers Research Group
3

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.

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.
TBD

There are currently no biomarkers annotated for this protocol.

No datasets are currently associated with this protocol.


2015 EDRN PI Orientation

The New and Continuing EDRN Principal Investigator Orientation will take place October 15–16, 2015 in Bethesda, Maryland.

Announcement 06/30/2015

A funding opportunity for a new pancreatic cancer initiative, called The Pancreatic Cancer Detection Consortium (U01), has been released. For more information, please go to http://grants.nih.gov /grants/guide/ pa-files/ PAR-15-289.html.

Announcement 04/08/2015

Thank you to everyone who made the 29th EDRN Steering Committee Meeting a success. The orientation for new and continuing EDRN PIs will be held October 15-16, 2015 on the NCI campus. More information will be available later this summer.