Rationale and design of the Hepatocellular carcinoma Early Detection Strategy study: A multi-center longitudinal initiative of the National Cancer Institute’s Early Detection Research Network

Hepatocellular carcinoma (HCC) is a common malignancy with a steadily rising incidence and associated morbidity and mortality. Cirrhosis of the liver is presently the leading risk factor for developing HCC. Abdominal imaging, with or without alpha-fetoprotein (AFP) testing, every 6 months is the cur...

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Published in	Contemporary clinical trials Vol. 76; pp. 49 - 54
Main Authors	Borges, Kelly A., Dai, Jianliang, Parikh, Neehar D., Schwartz, Myron, Nguyen, Mindie H., Roberts, Lewis R., Befeler, Alex S., Srivastava, Sudhir, Rinaudo, Jo Ann, Feng, Ziding, Marrero, Jorge A., Reddy, K. Rajender
Format	Journal Article
Language	English
Published	United States Elsevier Inc 01.01.2019
Subjects	Adolescent Adult Aged Aged, 80 and over alpha-Fetoproteins - metabolism Biomarker Biomarkers - metabolism Biomarkers, Tumor - metabolism Cancer surveillance Carcinoma, Hepatocellular - diagnosis Carcinoma, Hepatocellular - metabolism Carcinoma, Hepatocellular - pathology Early Detection of Cancer Female Hepatocellular carcinoma Humans Liver - diagnostic imaging Liver Cirrhosis Liver Neoplasms - diagnosis Liver Neoplasms - metabolism Liver Neoplasms - pathology Longitudinal Studies Male Middle Aged Multicenter Studies as Topic National Cancer Institute (U.S.) Protein Precursors - metabolism Prothrombin - metabolism Real-world Research design Sensitivity and Specificity Ultrasonography United States Young Adult United States T2DM NAFLD Biomarker DAA MRI Cancer surveillance DCP-V Real-world HCC Hepatocellular carcinoma AFP NASH NIH HEDS DCP CT MELD NCI HCV Research design EDRN HBV US
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ISSN	1551-7144 1559-2030 1559-2030
DOI	10.1016/j.cct.2018.11.008

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Abstract	Hepatocellular carcinoma (HCC) is a common malignancy with a steadily rising incidence and associated morbidity and mortality. Cirrhosis of the liver is presently the leading risk factor for developing HCC. Abdominal imaging, with or without alpha-fetoprotein (AFP) testing, every 6 months is the current surveillance strategy for patients at risk. The available biomarkers for detecting this cancer at an early stage have inadequate sensitivity and specificity. The Hepatocellular carcinoma Early Detection Strategy (HEDS) study, a multi-center initiative of the National Cancer Institutes' (NCI) Early Detection Research Network (EDRN), launched an effort to establish what has become the nation's largest comprehensive biorepository and database on patients at high risk of developing HCC. The cohort has been developed in seven clinical centers across the USA. Subjects are enrolled for a five-year period involving data and specimen collection every six months in accordance with standard surveillance for HCC. Extensive clinical data are collected and specimens are stored at a central repository. The database and biorepository contain longitudinally collected clinical data and serum and plasma samples from 1482 participants with cirrhosis and without evidence of HCC at baseline. Fifty-six percent are male, 85% Caucasian, 30% have a history of chronic HCV and 71% have compensated cirrhosis. The HEDS cohort provides opportunities for the continued study of the incidence and course of HCC in a comprehensively followed population of patients at high risk for this malignancy. Further, the EDRN biorepository provides a distinct opportunity for the development of novel biomarkers. Trial registry URL: https://edrn.nci.nih.gov/protocols/316-hepatocellular-carcinoma-early-detection-strategy.
AbstractList	Hepatocellular carcinoma (HCC) is a common malignancy with a steadily rising incidence and associated morbidity and mortality. Cirrhosis of the liver is presently the leading risk factor for developing HCC. Abdominal imaging, with or without alpha-fetoprotein (AFP) testing, every 6 months is the current surveillance strategy for patients at risk. The available biomarkers for detecting this cancer at an early stage have inadequate sensitivity and specificity. The Hepatocellular carcinoma Early Detection Strategy (HEDS) study, a multi-center initiative of the National Cancer Institutes' (NCI) Early Detection Research Network (EDRN), launched an effort to establish what has become the nation's largest comprehensive biorepository and database on patients at high risk of developing HCC. The cohort has been developed in seven clinical centers across the USA. Subjects are enrolled for a five-year period involving data and specimen collection every six months in accordance with standard surveillance for HCC. Extensive clinical data are collected and specimens are stored at a central repository. The database and biorepository contain longitudinally collected clinical data and serum and plasma samples from 1482 participants with cirrhosis and without evidence of HCC at baseline. Fifty-six percent are male, 85% Caucasian, 30% have a history of chronic HCV and 71% have compensated cirrhosis. The HEDS cohort provides opportunities for the continued study of the incidence and course of HCC in a comprehensively followed population of patients at high risk for this malignancy. Further, the EDRN biorepository provides a distinct opportunity for the development of novel biomarkers. Trial registry URL: https://edrn.nci.nih.gov/protocols/316-hepatocellular-carcinoma-early-detection-strategy. Hepatocellular carcinoma (HCC) is a common malignancy with a steadily rising incidence and associated morbidity and mortality. Cirrhosis of the liver is presently the leading risk factor for developing HCC. Abdominal imaging, with or without alpha-fetoprotein (AFP) testing, every 6 months is the current surveillance strategy for patients at risk. The available biomarkers for detecting this cancer at an early stage have inadequate sensitivity and specificity. The Hepatocellular carcinoma Early Detection Strategy (HEDS) study, a multi-center initiative of the National Cancer Institutes' (NCI) Early Detection Research Network (EDRN), launched an effort to establish what has become the nation's largest comprehensive biorepository and database on patients at high risk of developing HCC. The cohort has been developed in seven clinical centers across the USA. Subjects are enrolled for a five-year period involving data and specimen collection every six months in accordance with standard surveillance for HCC. Extensive clinical data are collected and specimens are stored at a central repository. The database and biorepository contain longitudinally collected clinical data and serum and plasma samples from 1482 participants with cirrhosis and without evidence of HCC at baseline. Fifty-six percent are male, 85% Caucasian, 30% have a history of chronic HCV and 71% have compensated cirrhosis. The HEDS cohort provides opportunities for the continued study of the incidence and course of HCC in a comprehensively followed population of patients at high risk for this malignancy. Further, the EDRN biorepository provides a distinct opportunity for the development of novel biomarkers. Trial registry URL: https://edrn.nci.nih.gov/protocols/316-hepatocellular-carcinoma-early-detection-strategy. Hepatocellular carcinoma (HCC) is a common malignancy with a steadily rising incidence and associated morbidity and mortality. Cirrhosis of the liver is presently the leading risk factor for developing HCC. Abdominal imaging, with or without alpha-fetoprotein (AFP) testing, every 6 months is the current surveillance strategy for patients at risk. The available biomarkers for detecting this cancer at an early stage have inadequate sensitivity and specificity.BACKGROUNDHepatocellular carcinoma (HCC) is a common malignancy with a steadily rising incidence and associated morbidity and mortality. Cirrhosis of the liver is presently the leading risk factor for developing HCC. Abdominal imaging, with or without alpha-fetoprotein (AFP) testing, every 6 months is the current surveillance strategy for patients at risk. The available biomarkers for detecting this cancer at an early stage have inadequate sensitivity and specificity.The Hepatocellular carcinoma Early Detection Strategy (HEDS) study, a multi-center initiative of the National Cancer Institutes' (NCI) Early Detection Research Network (EDRN), launched an effort to establish what has become the nation's largest comprehensive biorepository and database on patients at high risk of developing HCC. The cohort has been developed in seven clinical centers across the USA. Subjects are enrolled for a five-year period involving data and specimen collection every six months in accordance with standard surveillance for HCC. Extensive clinical data are collected and specimens are stored at a central repository.METHODSThe Hepatocellular carcinoma Early Detection Strategy (HEDS) study, a multi-center initiative of the National Cancer Institutes' (NCI) Early Detection Research Network (EDRN), launched an effort to establish what has become the nation's largest comprehensive biorepository and database on patients at high risk of developing HCC. The cohort has been developed in seven clinical centers across the USA. Subjects are enrolled for a five-year period involving data and specimen collection every six months in accordance with standard surveillance for HCC. Extensive clinical data are collected and specimens are stored at a central repository.The database and biorepository contain longitudinally collected clinical data and serum and plasma samples from 1482 participants with cirrhosis and without evidence of HCC at baseline. Fifty-six percent are male, 85% Caucasian, 30% have a history of chronic HCV and 71% have compensated cirrhosis.RESULTSThe database and biorepository contain longitudinally collected clinical data and serum and plasma samples from 1482 participants with cirrhosis and without evidence of HCC at baseline. Fifty-six percent are male, 85% Caucasian, 30% have a history of chronic HCV and 71% have compensated cirrhosis.The HEDS cohort provides opportunities for the continued study of the incidence and course of HCC in a comprehensively followed population of patients at high risk for this malignancy. Further, the EDRN biorepository provides a distinct opportunity for the development of novel biomarkers. Trial registry URL: https://edrn.nci.nih.gov/protocols/316-hepatocellular-carcinoma-early-detection-strategy.CONCLUSIONSThe HEDS cohort provides opportunities for the continued study of the incidence and course of HCC in a comprehensively followed population of patients at high risk for this malignancy. Further, the EDRN biorepository provides a distinct opportunity for the development of novel biomarkers. Trial registry URL: https://edrn.nci.nih.gov/protocols/316-hepatocellular-carcinoma-early-detection-strategy.
Author	Srivastava, Sudhir Dai, Jianliang Marrero, Jorge A. Feng, Ziding Nguyen, Mindie H. Borges, Kelly A. Parikh, Neehar D. Rinaudo, Jo Ann Schwartz, Myron Roberts, Lewis R. Befeler, Alex S. Reddy, K. Rajender
AuthorAffiliation	1. University of Pennsylvania, Philadelphia, PA, USA 9. University of Texas Southwestern Medical Center, Dallas, TX, USA 6. Mayo Clinic, Rochester, MN, USA 2. Fred Hutchinson Cancer Research Center, Seattle, WA, USA 8. National Cancer Institute, Bethesda, MD, USA 4. Mount Sinai Hospital, New York, NY, USA 5. Stanford University, Stanford, CA, USA 7. Saint Louis University, St. Louis, MO, USA 3. University of Michigan, Ann Arbor, MI, USA
AuthorAffiliation_xml	– name: 6. Mayo Clinic, Rochester, MN, USA – name: 8. National Cancer Institute, Bethesda, MD, USA – name: 2. Fred Hutchinson Cancer Research Center, Seattle, WA, USA – name: 1. University of Pennsylvania, Philadelphia, PA, USA – name: 3. University of Michigan, Ann Arbor, MI, USA – name: 9. University of Texas Southwestern Medical Center, Dallas, TX, USA – name: 4. Mount Sinai Hospital, New York, NY, USA – name: 5. Stanford University, Stanford, CA, USA – name: 7. Saint Louis University, St. Louis, MO, USA
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Keywords	T2DM NAFLD Biomarker DAA MRI Cancer surveillance DCP-V Real-world HCC Hepatocellular carcinoma AFP NASH NIH HEDS DCP CT MELD NCI HCV Research design EDRN HBV US
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Notes	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23 K. Rajender Reddy: Hospital of the University of Pennsylvania, 2 Dulles, 3400 Spruce Street, Philadelphia, PA 19104 Alex S. Befeler: Saint Louis University, 1 N Grand Blvd, St. Louis, MO 63103 Myron Schwartz: Mount Sinai Hospital, 1468 Madison Ave, New York, NY 10029 Jorge A. Marrero: UT Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390 Sudhir Srivastava: National Cancer Institute, 9000 Rockville Pike, Bethesda, MD 20892 Neehar D. Parikh: University of Michigan, 1500 E Medical Center Dr. Taubman Center SPC 3912, Ann Arbor, MI 48109 Ziding Feng: Fred Hutchinson Cancer Research Center,1100 Fairview Ave N, Seattle, WA 98109 Jo Ann Rinaudo: National Cancer Institute, 9000 Rockville Pike, Bethesda, MD 20892 Co-Senior Authors Jianliang Dai: Fred Hutchinson Cancer Research Center,1100 Fairview Ave N, Seattle, WA 98109 Kelly A. Borges: Perelman Center for Advanced Medicine, 3400 Civic Center Blvd 7S, Philadelphia, PA, 19104 Lewis R. Roberts: Mayo Clinic, 200 1st St SW, Rochester, MN 55905 Mindie H. Nguyen: Stanford University, 750 Welch Road, #210, Palo Alto, CA 94304 AUTHOR INFORMATION
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Snippet	Hepatocellular carcinoma (HCC) is a common malignancy with a steadily rising incidence and associated morbidity and mortality. Cirrhosis of the liver is...
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SubjectTerms	Adolescent Adult Aged Aged, 80 and over alpha-Fetoproteins - metabolism Biomarker Biomarkers - metabolism Biomarkers, Tumor - metabolism Cancer surveillance Carcinoma, Hepatocellular - diagnosis Carcinoma, Hepatocellular - metabolism Carcinoma, Hepatocellular - pathology Early Detection of Cancer Female Hepatocellular carcinoma Humans Liver - diagnostic imaging Liver Cirrhosis Liver Neoplasms - diagnosis Liver Neoplasms - metabolism Liver Neoplasms - pathology Longitudinal Studies Male Middle Aged Multicenter Studies as Topic National Cancer Institute (U.S.) Protein Precursors - metabolism Prothrombin - metabolism Real-world Research design Sensitivity and Specificity Ultrasonography United States Young Adult
Title	Rationale and design of the Hepatocellular carcinoma Early Detection Strategy study: A multi-center longitudinal initiative of the National Cancer Institute’s Early Detection Research Network
URI	https://www.clinicalkey.com/#!/content/1-s2.0-S1551714418305640 https://dx.doi.org/10.1016/j.cct.2018.11.008 https://www.ncbi.nlm.nih.gov/pubmed/30439517 https://www.proquest.com/docview/2135136060 https://pubmed.ncbi.nlm.nih.gov/PMC7086481
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