Kelly A Borges1, Jianliang Dai2, Neehar D Parikh3, Myron Schwartz4, Mindie H Nguyen5, Lewis R Roberts6, Alex S Befeler7, Sudhir Srivastava8, Jo Ann Rinaudo9, Ziding Feng10, Jorge A Marrero11, K Rajender Reddy12. 1. Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd 7S, Philadelphia, PA, 19104, USA. Electronic address: Kelly.borges@uphs.upenn.edu. 2. Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA 98109, USA. Electronic address: jdai4@mdanderson.org. 3. University of Michigan, 1500 E Medical Center Dr. Taubman Center SPC 3912, Ann Arbor, MI 48109, USA. Electronic address: ndparikh@med.umich.edu. 4. Mount Sinai Hospital, 1468 Madison Ave, New York, NY 10029, USA. Electronic address: myron.schwartz@mountsinai.org. 5. Stanford University, Stanford, 750 Welch Road, #210, Palo Alto, CA 94304, USA. Electronic address: mindiehn@stanford.edu. 6. Mayo Clinic, 200 1st St SW, Rochester, MN 55905, USA. Electronic address: lewis.roberts@mayo.edu. 7. Saint Louis University, 1 N Grand Blvd, St. Louis, MO 63103, USA. Electronic address: alex.befeler@health.slu.edu. 8. National Cancer Institute, 9000 Rockville Pike, Bethesda, MD 20892, USA. Electronic address: srivasts@mail.nih.gov. 9. National Cancer Institute, 9000 Rockville Pike, Bethesda, MD 20892, USA. Electronic address: rinaudoj@mail.nih.gov. 10. Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA 98109, USA. Electronic address: zfeng3@mdanderson.org. 11. University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390, USA. Electronic address: jorge.marrero@utsouthwestern.edu. 12. Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd 7S, Philadelphia, PA, 19104, USA. Electronic address: rajender.reddy@uphs.upenn.edu.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
BACKGROUND: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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
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