Table 1.
Descriptions and key eligibility criteria of cohorts enrolled in DCP-V and HEDS studies.
| DCP-V | HEDS n = 1482 | |
|---|---|---|
| CASES (HCC) n = 372 | CONTROLS (NO HCC) n = 374 | |
| - AFP labs within 180 days - All other labs within past 90 days - Diagnosis of HCC based on: histology*, two imaging tests** - MELD < 15 OR INR < 1.5, t.bili < 1.7 and history of intrinsic renal disease - No prior or current treatment of HCC - No cancer history within 5 years*** - No Participation in a trial for HCC treatment - No undiagnosed liver mass |
- Albumin, Bilirubin, Creatinine and INR labs within past 90 days - Imaging**** showing no HCC within 180 days - Diagnosis of cirrhosis based on: histology, image showing cirrhotic liver with splenomegaly and platelets < 120 mm3, Esophageal or gastric varices on endoscopy AND presence of chronic liver disease - MELD < 15 -OR- INR < 1.5, t.bili < 1.7 and history of intrinsic renal disease - No significant hepatic decompensation****** - No hepatorenal syndrome - AFP labs within 180 days, AFP < 20 ng/ml***** - No cancer history within 5 years*** - No prior solid organ transplant |
- Albumin, Bilirubin, Creatinine and
INR labs within 180 days****
- Imaging**** showing no HCC within 180 days - Diagnosis of cirrhosis based on: histology, imaging showing cirrhotic liver with splenomegaly AND platelets < 120 mm-3, Elastography indicating cirrhosis, FibroTest result of F4, Varices AND chronic liver disease - MELD < 15 -OR- INR < 1.5, T.Bili < 1.7 and history of intrinsic renal disease - No significant hepatic decompensation****** - No hepatorenal syndrome - Not listed for liver transplantation and noted as “exception” - No known AIDS related diseases - No significant co-morbid conditions with life expectancy < 1 year - No cancer history within 5 years*** - No prior solid organ transplant |
DCP-V controls who remained HCC-free at time of abstraction were screened to meet eligibility criteria for HEDS enrollment prior to being approached for consent to continue follow-up in HEDS study.
required if only one lesion < 2 cm is present) – Must have CT/MRI to calculate stage
with at least one (CT/MRI/Angiography) within the past 3 months or up to 2 weeks after consent showing evidence of arterial hypervascularization, and the other within the past 6 months (US, CT, MRI/Angiography) indicating a mass in the liver.
(excluding non-melanoma skin cancer)
within 6 months prior to enrollment OR up to 2 weeks after consent
without proof of a dynamic CT scan or triple phase MRI within 3 months prior to consent OR up to 2 weeks after consent indicating no mass
Grade 3–4 encephalopathy, refractory ascites, CTP class C