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Design of the Texas Hepatocellular Carcinoma Consortium Cohort Study

Feng, Ziding, PhD1; Marrero, Jorge A., MD2; Khaderi, Saira, MD3,4; Singal, Amit G., MD2; Kanwal, Fasiha, MD4; Loo, Nicole, MD5; Beretta, Laura, PhD6; Ning, Jing, PhD1; El-Serag, Hashem B., MD, MPH4

American Journal of Gastroenterology: March 2019 - Volume 114 - Issue 3 - p 530–532
doi: 10.14309/ajg.0000000000000068
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OBJECTIVES: The Texas Hepatocellular Carcinoma Consortium cohort study investigates risk factors of hepatocellular carcinoma (HCC) and biomarkers for early HCC detection in patients with liver cirrhosis.

METHODS: Adult patients with liver cirrhosis are enrolled at 5 clinical centers from 3 cities in Texas, with a target of 5,000 patients. Clinical history, risk factor questionnaires, liver imaging, laboratory data, and blood samples were collected at enrollment and at each 6-month follow-up visit.

RESULTS: The primary outcome was the development of HCC. Biomarkers were tested in banked blood samples using prospective specimen collection, retrospective blinded evaluation design.

CONCLUSIONS: We describe study design, eligibility criteria, recruitment, study cores, and sample size and analysis considerations.

1Department of Biostatistics, UT MD Anderson Cancer Center, Houston, Texas, USA;

2Division of Digestive and Liver Diseases, Department of Medicine, UT Southwestern Medical Center, Dallas, Texas, USA;

3Division of Abdominal Transplantation, Baylor College of Medicine, Houston, Texas, USA;

4Section of Gastroenterology and Hepatology, Department of Medicine, Baylor College of Medicine and Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, USA;

5Department of Medicine, Texas Liver Institute, San Antonio, Texas, USA;

6Department of Molecular and Cellular Oncology, UT MD Anderson Cancer Center, Houston, Texas, USA.

Correspondence: Hashem B. El-Serag. E-mail: hasheme@bcm.edu.

Received August 14, 2018

Accepted September 17, 2018

© The American College of Gastroenterology 2019. All Rights Reserved.
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