Form:DCP Eligibility v1.3


CDE IDCDE Description
* 421EDRN Participant ID (Go To: 773)
* 773Visit code (Go To: 423)
 
Permissible Values (value):BLN1 (1)
 
 BLN2 (2)
 
 BLN3 (3)
 
 BLN4 (4)
* 423EDRN Protocol ID (Go To: 422)
* 422EDRN Site ID (Go To: 1056)
* 1056Proposed study group (Go To: 807)
 
Permissible Values (value):Cases group 1 (1)
 
 Control Group 2 (2)
* 807Date of baseline visit: (Go To: 929)
* 929EDRN Staff ID of the person who collected the data: (Go To: 794)
* 794Date of birth: (What is your date of birth?) (Go To: 948)
* 948Does the participant currently have cirrhosis? (Go To: 951)
 
Permissible Values (value):No (0)
 
 Yes (1) (Go To: 987)
* 987Cirrhosis diagnosis based on: (Go To: 950)
 
Permissible Values (value):Liver histology (1)
 
 Judgment of the treating physician (2) (Go To: 988)
* 988Does the participant have an imaging test showing a cirrhotic liver with splenomegaly? (Go To: 989)
 
Permissible Values (value):No (0)
 
 Yes (1)
* 989Does the participant have a platelet count of less than 120 K/mm3? (Go To: 950)
 
Permissible Values (value):No (0)
 
 Yes (1)
   950Year in which participant first met diagnostic criteria for cirrhosis: (Go To: 1718)
* 1718Does the participant have chronic liver disease? (Go To: 1719)
 
Permissible Values (value):No (0)
 
 Yes (1)
* 1719Does the participant currently have esophageal varices? (Go To: 1720)
 
Permissible Values (value):No (0)
 
 Yes (1)
* 1720Does the participant currently have gastric varices? (Go To: 951)
 
Permissible Values (value):No (0)
 
 Yes (1)
* 951Does the participant currently have an undiagnosed hepatic mass? (Go To: 1103)
 
Permissible Values (value):No (0)
 
 Yes (1)
* 1103In 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)
 
 Yes (1) (Go To: 1104)
* 1104In 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)
 
 Yes (1) (Go To: 995)
   995Date on which participant first met diagnostic criteria for hepatocellular carcinoma (HCC): (Go To: 961)
* 961Has participant ever received therapy for hepatocellular carcinoma (HCC)? (Go To: 963)
 
Permissible Values (value):No (0)
 
 Yes (1) (Go To: 962)
* 962Is participant currently receiving therapy for hepatocellular carcinoma (HCC)? (Go To: 963)
 
Permissible Values (value):No (0)
 
 Yes (1)
* 963Is participant enrolled in a clinical trial for hepatocellular carcinoma (HCC)? (Go To: 1206)
 
Permissible Values (value):No (0)
 
 Yes (1) (Go To: 964)
* 964Were 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)
 
 Yes (1)
* 1206Is pathology report for current hepatocellular carcinoma available? (Go To: 954)
 
Permissible Values (value):No (0)
 
 Yes (1) (Go To: 968)
   968Date of procedure that generated pathology report (MM/DD/YYYY): (Go To: 706)
   706Method of acquisition (Go To: 954)
 
Permissible Values (value):Biopsy (1)
 
 Excised during surgery (2)
 
 Fine needle aspirate (3)
* 954Number of liver imaging tests used to diagnose (HCC or cirrhosis) within the last six months: (Go To: 955)
* 955Date of imaging test (MM/DD/YYYY): (Go To: 956)
* 956Type of abdominal imaging: (Go To: 965)
 
Permissible Values (value):Ultrasound (1)
 
 CT scan (2)
 
 Angiogram (3)
 
 MRI (4)
 
 Other, specify: (97) (Go To: 957)
   957Type of abdominal imaging (other, specify): (Go To: 965)
* 965Number of lesions (Go To: 966)
   966Maximum diameter of largest lesion (in cm) (Go To: 958)
* 958Evidence of arterial hypervascularization? (Go To: 959)
 
Permissible Values (value):No (0)
 
 Yes (1)
* 959Evidence of portal vein thrombosis? (Go To: 960)
 
Permissible Values (value):No (0)
 
 Yes (1)
* 960Evidence of metastases, including extrahepatic portal or hepatic vein? (Go To: 1057)
 
Permissible Values (value):No (0)
 
 Yes (1)
* 1057Does participant currently have ascites? (Go To: 1058)
 
Permissible Values (value):No (0)
 
 Controlled (1)
 
 Uncontrolled (2)
* 1058Does participant currently have encephalopathy? (Go To: 991)
 
Permissible Values (value):No (0)
 
 Controlled (1)
 
 Uncontrolled (2)
* 991Does participant have co-morbid medical conditions with life expectancy less than one year? (Go To: 1208)
 
Permissible Values (value):No (0)
 
 Yes (1)
* 1208Does participant require long-term immunosuppressive therapy for solid organ transplant? (Go To: 993)
 
Permissible Values (value):No (0)
 
 Yes (1)
* 993Has the participant had a prior solid organ transplant? (Go To: 1017)
 
Permissible Values (value):No (0)
 
 Yes (1)
* 1017Based 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)
 
 Autoimmune (3)
 
 Hemochromatosis (4)
 
 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)
 
 Wilsons disease (10)
 
 Cryptogenic (11)
 
 Refused (88)
 
 Other, specify: (97) (Go To: 1023)
   1023Based on the judgement of the treating physician, what is the liver disease etiology (other, specify)? (Go To: 994)
   1020Hepatitis B surface antigen (HBsAg) (Go To: 1091)
 
Permissible Values (value):Positive (1)
 
 Negative (2)
 
 Not done (3)
   1091Was Hepatitis B DNA detectable? (Go To: 1092)
 
Permissible Values (value):No (0)
 
 Yes (1)
 
 Not done (3)
   1092Was Hepatitis B e-antigen detectable? (Go To: 1093)
 
Permissible Values (value):No (0)
 
 Yes (1)
 
 Not done (3)
   1093Mode of Hepatitis B contraction: (Go To: 1094)
 
Permissible Values (value):Transfusion (1)
 
 IV drug use (2)
 
 Maternal-fetal transmission (3)
 
 Tattoos (4)
 
 Other, specify: (7) (Go To: 1098)
 
 Unknown/refused (9)
   1098Mode of hepatitis B contraction (other, specify): (Go To: 1094)
   1094Length 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)
 
 Unknown/refused (9)
   1018HCV Ab (Go To: 1019)
 
Permissible Values (value):Positive (1)
 
 Negative (2)
 
 Not done (3)
 
 Unknown/refused (9)
   1019HCV RNA (Go To: 1088)
 
Permissible Values (value):Positive (1) (Go To: 1095)
 
 Negative (2)
 
 Not done (3)
 
 Unknown/refused (9)
   1095Viral load (Hepatitis C RNA) value: (Go To: 1096)
   1096Viral load (Hepatitis C RNA) unit: (Go To: 1088)
 
Permissible Values (value):IU/ml (1)
 
 Copies/ml (2)
   1088Genotype unit (Hepatitis C): (Go To: 1089)
 
Permissible Values (value):1 (1)
 
 2 (2)
 
 3 (3)
 
 4 (4)
 
 5 (5)
 
 6 (6)
 
 Unknown/refused (9)
 
 Not done (33)
   1089Mode of Hepatitis C contraction: (Go To: 1090)
 
Permissible Values (value):Transfusion (1)
 
 IV drug use (2)
 
 Maternal-fetal transmission (3)
 
 Tattoos (4)
 
 Other, specify: (7) (Go To: 1099)
 
 Unknown/refused (9)
   1099Mode of hepatitis C contraction (other, specify): (Go To: 1090)
   1090Length 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)
 
 Unknown/refused (9)
* 994Has participant received hemodialysis twice within the past week? (Go To: 1187)
 
Permissible Values (value):No (0)
 
 Yes (1)
* 1187Does the participant have a history of intrinsic renal disease? (Go To: 1097)
 
Permissible Values (value):No (0)
 
 Yes (1)
   1097Comments (do not include any participant identifiers) (Go To: End of Form)