CDE ID | CDE Description | * 421 | EDRN Participant ID (Go To: 773) |
* 773 | Visit code (Go To: 423) |
| Permissible Values (value): | BLN1 (1) |
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* 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) |
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* 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) |
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* 987 | Cirrhosis diagnosis based on: (Go To: 950) |
| Permissible Values (value): | Liver histology (1) |
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| | Judgment of the treating physician (2) (Go To: 988) |
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* 988 | Does the participant have an imaging test showing a cirrhotic liver with splenomegaly? (Go To: 989) |
| Permissible Values (value): | No (0) |
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* 989 | Does the participant have a platelet count of less than 120 K/mm3? (Go To: 950) |
| Permissible Values (value): | No (0) |
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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) |
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* 1719 | Does the participant currently have esophageal varices? (Go To: 1720) |
| Permissible Values (value): | No (0) |
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* 1720 | Does the participant currently have gastric varices? (Go To: 951) |
| Permissible Values (value): | No (0) |
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* 951 | Does the participant currently have an undiagnosed hepatic mass? (Go To: 1103) |
| Permissible Values (value): | No (0) |
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* 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) |
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* 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) |
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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) |
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* 962 | Is participant currently receiving therapy for hepatocellular carcinoma (HCC)? (Go To: 963) |
| Permissible Values (value): | No (0) |
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* 963 | Is participant enrolled in a clinical trial for hepatocellular carcinoma (HCC)? (Go To: 1206) |
| Permissible Values (value): | No (0) |
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* 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) |
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* 1206 | Is pathology report for current hepatocellular carcinoma available? (Go To: 954) |
| Permissible Values (value): | No (0) |
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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) |
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| | Excised during surgery (2) |
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* 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) |
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| | Other, specify: (97) (Go To: 957) |
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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) |
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* 959 | Evidence of portal vein thrombosis? (Go To: 960) |
| Permissible Values (value): | No (0) |
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* 960 | Evidence of metastases, including extrahepatic portal or hepatic vein? (Go To: 1057) |
| Permissible Values (value): | No (0) |
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* 1057 | Does participant currently have ascites? (Go To: 1058) |
| Permissible Values (value): | No (0) |
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* 1058 | Does participant currently have encephalopathy? (Go To: 991) |
| Permissible Values (value): | No (0) |
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* 991 | Does participant have co-morbid medical conditions with life expectancy less than one year? (Go To: 1208) |
| Permissible Values (value): | No (0) |
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* 1208 | Does participant require long-term immunosuppressive therapy for solid organ transplant? (Go To: 993) |
| Permissible Values (value): | No (0) |
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* 993 | Has the participant had a prior solid organ transplant? (Go To: 1017) |
| Permissible Values (value): | No (0) |
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* 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) |
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| | Alpha-1 antitrypsin deficiency (2) |
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| | Hepatitis B (5) (Go To: 1020) |
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| | Hepatitis C (6) (Go To: 1018) |
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| | Non-alcoholic fatty liver (7) |
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| | Primary biliary cirrhosis (8) |
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| | Primary sclerosing cholangitis (9) |
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| | Other, specify: (97) (Go To: 1023) |
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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) |
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1091 | Was Hepatitis B DNA detectable? (Go To: 1092) |
| Permissible Values (value): | No (0) |
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1092 | Was Hepatitis B e-antigen detectable? (Go To: 1093) |
| Permissible Values (value): | No (0) |
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1093 | Mode of Hepatitis B contraction: (Go To: 1094) |
| Permissible Values (value): | Transfusion (1) |
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| | Maternal-fetal transmission (3) |
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| | Other, specify: (7) (Go To: 1098) |
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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) |
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| | Within the last 10 years (2) |
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| | Within the last 15 years (3) |
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| | Within the last 20 years (4) |
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| | Within the last 25 years (5) |
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| | Within the last 30 years or more (6) |
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1018 | HCV Ab (Go To: 1019) |
| Permissible Values (value): | Positive (1) |
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1019 | HCV RNA (Go To: 1088) |
| Permissible Values (value): | Positive (1) (Go To: 1095) |
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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) |
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1088 | Genotype unit (Hepatitis C): (Go To: 1089) |
| Permissible Values (value): | 1 (1) |
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1089 | Mode of Hepatitis C contraction: (Go To: 1090) |
| Permissible Values (value): | Transfusion (1) |
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| | Maternal-fetal transmission (3) |
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| | Other, specify: (7) (Go To: 1099) |
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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) |
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| | Within the last 10 years (2) |
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| | Within the last 15 years (3) |
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| | Within the last 20 years (4) |
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| | Within the last 25 years (5) |
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| | Within the last 30 years or more (6) |
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* 994 | Has participant received hemodialysis twice within the past week? (Go To: 1187) |
| Permissible Values (value): | No (0) |
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* 1187 | Does the participant have a history of intrinsic renal disease? (Go To: 1097) |
| Permissible Values (value): | No (0) |
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1097 | Comments (do not include any participant identifiers) (Go To: End of Form) |