| CDE ID | CDE Description | | * 421 | EDRN Participant ID (Go To: 773) |
| * 773 | Visit code (Go To: 423) |
| | | Permissible Values (value): | BLN1 (1) |
|
| | |
| | |
| | |
| * 423 | EDRN Protocol ID (Go To: 422) |
| * 422 | EDRN Site ID (Go To: 1056) |
| * 1056 | Proposed study group (Go To: 807) |
| | | Permissible Values (value): | Cases group 1 (1) |
|
| | |
| * 807 | Date of baseline visit: (Go To: 929) |
| * 929 | EDRN Staff ID of the person who collected the data: (Go To: 794) |
| * 794 | Date of birth: (What is your date of birth?) (Go To: 948) |
| * 948 | Does the participant currently have cirrhosis? (Go To: 951) |
| | | Permissible Values (value): | No (0) |
|
| | |
| * 987 | Cirrhosis diagnosis based on: (Go To: 950) |
| | | Permissible Values (value): | Liver histology (1) |
|
| | | | Judgment of the treating physician (2) (Go To: 988) |
|
| * 988 | Does the participant have an imaging test showing a cirrhotic liver with splenomegaly? (Go To: 989) |
| | | Permissible Values (value): | No (0) |
|
| | |
| * 989 | Does the participant have a platelet count of less than 120 K/mm3? (Go To: 950) |
| | | Permissible Values (value): | No (0) |
|
| | |
| 950 | Year in which participant first met diagnostic criteria for cirrhosis: (Go To: 1718) |
| * 1718 | Does the participant have chronic liver disease? (Go To: 1719) |
| | | Permissible Values (value): | No (0) |
|
| | |
| * 1719 | Does the participant currently have esophageal varices? (Go To: 1720) |
| | | Permissible Values (value): | No (0) |
|
| | |
| * 1720 | Does the participant currently have gastric varices? (Go To: 951) |
| | | Permissible Values (value): | No (0) |
|
| | |
| * 951 | Does the participant currently have an undiagnosed hepatic mass? (Go To: 1103) |
| | | Permissible Values (value): | No (0) |
|
| | |
| * 1103 | In the past five years has participant had cancer [other than basal/squamous cell skin cancer] confirmed by a doctor? (In the past five years have you had cancer [other than basal/squamous cell skin cancer] confirmed by a doctor?) (Go To: 954) |
| | | Permissible Values (value): | No (0) |
|
| | |
| * 1104 | In the past five years is hepatocellular carcinoma (HCC) the only type of cancer (other than basal/squamous cell skin cancer) the participant has had? (Go To: 954) |
| | | Permissible Values (value): | No (0) |
|
| | |
| 995 | Date on which participant first met diagnostic criteria for hepatocellular carcinoma (HCC): (Go To: 961) |
| * 961 | Has participant ever received therapy for hepatocellular carcinoma (HCC)? (Go To: 963) |
| | | Permissible Values (value): | No (0) |
|
| | |
| * 962 | Is participant currently receiving therapy for hepatocellular carcinoma (HCC)? (Go To: 963) |
| | | Permissible Values (value): | No (0) |
|
| | |
| * 963 | Is participant enrolled in a clinical trial for hepatocellular carcinoma (HCC)? (Go To: 1206) |
| | | Permissible Values (value): | No (0) |
|
| | |
| * 964 | Were DCP data and blood obtained before the participant enrolled in the clinical trial for hepatocellular carcinoma (HCC)? (Go To: 1206) |
| | | Permissible Values (value): | No (0) |
|
| | |
| * 1206 | Is pathology report for current hepatocellular carcinoma available? (Go To: 954) |
| | | Permissible Values (value): | No (0) |
|
| | |
| 968 | Date of procedure that generated pathology report (MM/DD/YYYY): (Go To: 706) |
| 706 | Method of acquisition (Go To: 954) |
| | | Permissible Values (value): | Biopsy (1) |
|
| | | | Excised during surgery (2) |
|
| | |
| * 954 | Number of liver imaging tests used to diagnose (HCC or cirrhosis) within the last six months: (Go To: 955) |
| * 955 | Date of imaging test (MM/DD/YYYY): (Go To: 956) |
| * 956 | Type of abdominal imaging: (Go To: 965) |
| | | Permissible Values (value): | Ultrasound (1) |
|
| | |
| | |
| | |
| | | | Other, specify: (97) (Go To: 957) |
|
| 957 | Type of abdominal imaging (other, specify): (Go To: 965) |
| * 965 | Number of lesions (Go To: 966) |
| 966 | Maximum diameter of largest lesion (in cm) (Go To: 958) |
| * 958 | Evidence of arterial hypervascularization? (Go To: 959) |
| | | Permissible Values (value): | No (0) |
|
| | |
| * 959 | Evidence of portal vein thrombosis? (Go To: 960) |
| | | Permissible Values (value): | No (0) |
|
| | |
| * 960 | Evidence of metastases, including extrahepatic portal or hepatic vein? (Go To: 1057) |
| | | Permissible Values (value): | No (0) |
|
| | |
| * 1057 | Does participant currently have ascites? (Go To: 1058) |
| | | Permissible Values (value): | No (0) |
|
| | |
| | |
| * 1058 | Does participant currently have encephalopathy? (Go To: 991) |
| | | Permissible Values (value): | No (0) |
|
| | |
| | |
| * 991 | Does participant have co-morbid medical conditions with life expectancy less than one year? (Go To: 1208) |
| | | Permissible Values (value): | No (0) |
|
| | |
| * 1208 | Does participant require long-term immunosuppressive therapy for solid organ transplant? (Go To: 993) |
| | | Permissible Values (value): | No (0) |
|
| | |
| * 993 | Has the participant had a prior solid organ transplant? (Go To: 1017) |
| | | Permissible Values (value): | No (0) |
|
| | |
| * 1017 | Based on the judgment of the treating physician, what is the liver disease etiology? Check all that apply. (Go To: 994) |
| | | Permissible Values (value): | Alcoholic liver disease (1) |
|
| | | | Alpha-1 antitrypsin deficiency (2) |
|
| | |
| | |
| | | | Hepatitis B (5) (Go To: 1020) |
|
| | | | Hepatitis C (6) (Go To: 1018) |
|
| | | | Non-alcoholic fatty liver (7) |
|
| | | | Primary biliary cirrhosis (8) |
|
| | | | Primary sclerosing cholangitis (9) |
|
| | |
| | |
| | |
| | | | Other, specify: (97) (Go To: 1023) |
|
| 1023 | Based on the judgement of the treating physician, what is the liver disease etiology (other, specify)? (Go To: 994) |
| 1020 | Hepatitis B surface antigen (HBsAg) (Go To: 1091) |
| | | Permissible Values (value): | Positive (1) |
|
| | |
| | |
| 1091 | Was Hepatitis B DNA detectable? (Go To: 1092) |
| | | Permissible Values (value): | No (0) |
|
| | |
| | |
| 1092 | Was Hepatitis B e-antigen detectable? (Go To: 1093) |
| | | Permissible Values (value): | No (0) |
|
| | |
| | |
| 1093 | Mode of Hepatitis B contraction: (Go To: 1094) |
| | | Permissible Values (value): | Transfusion (1) |
|
| | |
| | | | Maternal-fetal transmission (3) |
|
| | |
| | | | Other, specify: (7) (Go To: 1098) |
|
| | |
| 1098 | Mode of hepatitis B contraction (other, specify): (Go To: 1094) |
| 1094 | Length of infection: when was Hepatitis B contracted? (Go To: 994) |
| | | Permissible Values (value): | Within the last 5 years (1) |
|
| | | | Within the last 10 years (2) |
|
| | | | Within the last 15 years (3) |
|
| | | | Within the last 20 years (4) |
|
| | | | Within the last 25 years (5) |
|
| | | | Within the last 30 years or more (6) |
|
| | |
| 1018 | HCV Ab (Go To: 1019) |
| | | Permissible Values (value): | Positive (1) |
|
| | |
| | |
| | |
| 1019 | HCV RNA (Go To: 1088) |
| | | Permissible Values (value): | Positive (1) (Go To: 1095) |
|
| | |
| | |
| | |
| 1095 | Viral load (Hepatitis C RNA) value: (Go To: 1096) |
| 1096 | Viral load (Hepatitis C RNA) unit: (Go To: 1088) |
| | | Permissible Values (value): | IU/ml (1) |
|
| | |
| 1088 | Genotype unit (Hepatitis C): (Go To: 1089) |
| | | Permissible Values (value): | 1 (1) |
|
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| 1089 | Mode of Hepatitis C contraction: (Go To: 1090) |
| | | Permissible Values (value): | Transfusion (1) |
|
| | |
| | | | Maternal-fetal transmission (3) |
|
| | |
| | | | Other, specify: (7) (Go To: 1099) |
|
| | |
| 1099 | Mode of hepatitis C contraction (other, specify): (Go To: 1090) |
| 1090 | Length of infection: when was Hepatitis C contracted? (Go To: 994) |
| | | Permissible Values (value): | Within the last 5 years (1) |
|
| | | | Within the last 10 years (2) |
|
| | | | Within the last 15 years (3) |
|
| | | | Within the last 20 years (4) |
|
| | | | Within the last 25 years (5) |
|
| | | | Within the last 30 years or more (6) |
|
| | |
| * 994 | Has participant received hemodialysis twice within the past week? (Go To: 1187) |
| | | Permissible Values (value): | No (0) |
|
| | |
| * 1187 | Does the participant have a history of intrinsic renal disease? (Go To: 1097) |
| | | Permissible Values (value): | No (0) |
|
| | |
| 1097 | Comments (do not include any participant identifiers) (Go To: End of Form) |