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.
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.
The primary outcome was the development of HCC. Biomarkers were tested in banked blood samples using prospective specimen collection, retrospective blinded evaluation design.
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: firstname.lastname@example.org.
Received August 14, 2018
Accepted September 17, 2018