Liver carcinoma
Item
confirmed diagnosis of hcc according to the european association for the study of the liver criteria
boolean
C2239176 (UMLS CUI [1])
Liver carcinoma Etiology | Hepatitis B | Hepatitis C | Status post Alcoholic Liver Cirrhosis
Item
known underlying hcc etiology specified by hepatitis b, hepatitis c, post alcoholic cirrhosis, or other
boolean
C2239176 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C0023891 (UMLS CUI [4,2])
Liver carcinoma Lesion unresectable | Measurable lesion CT scan
Item
hcc lesion(s) which are not resectable and which are measurable by c-t scan
boolean
C2239176 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1519810 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
Disease Progression | Liver carcinoma Lesion Unresponsive to Treatment | Status post Standard of Care best | Excision | Radiofrequency ablation | Chemoembolization
Item
progression of or non-response of hcc lesions after treatments which are considered best standard of care - surgical resection, radiofrequency ablation, chemoembolization
boolean
C0242656 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C2936643 (UMLS CUI [3,2])
C1522427 (UMLS CUI [3,3])
C0728940 (UMLS CUI [4])
C0850292 (UMLS CUI [5])
C0796679 (UMLS CUI [6])
Cancer treatment Absent | Operative Surgical Procedures Absent | Chemotherapy Absent | Biological treatment Targeted Absent | Enzyme Therapy Targeted Absent | Investigational Therapy Absent
Item
no cancer treatment or surgery within the prior 4 weeks, either chemotherapy, targeted biologic or enzymes, either approved or investigational;
boolean
C0920425 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1531518 (UMLS CUI [4,1])
C1521840 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0596530 (UMLS CUI [5,1])
C1521840 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0949266 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Age
Item
males or females from 18 to 75 years-old, inclusive;
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
ability and willingness to provide written informed consent;
boolean
C0021430 (UMLS CUI [1])
Karnofsky Performance Status | Life Expectancy
Item
karnofsky performance status of 80% or above and expected survival of more than 12 weeks; and,
boolean
C0206065 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Gender Urine pregnancy test negative | Gender Contraceptive methods
Item
negative urine pregnancy test, if female, and willingness to use an effective method of contraception during the entire study period
boolean
C0079399 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Liver Failure Advanced Child-Pugh Classification | Ascites Uncontrolled | Pleural effusion | Encephalopathy
Item
advancing liver failure indicated by uncontrolled ascites, pleural effusions, encephalopathy, or a child-pugh score of c
boolean
C0085605 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C2347612 (UMLS CUI [1,3])
C0003962 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0032227 (UMLS CUI [3])
C0085584 (UMLS CUI [4])
Liver Dysfunction | Renal dysfunction | Bone Marrow Dysfunction | Serum total bilirubin measurement | Cholestasis | Serum albumin measurement | Elevated SGOT | Absolute neutrophil count | Platelet Count measurement | International Normalized Ratio
Item
significant hepatic, renal or bone marrow dysfunction indicated by total bilirubin >40 µmol/l, evidence of bile duct obstruction, serum albumin <30 g/l, serum sgot >5 x upper limit of normal, anc <1.0 x 10^9/l, platelets <100 x 10^9/l, or inr >2.0
boolean
C0086565 (UMLS CUI [1])
C3279454 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C3887504 (UMLS CUI [3,2])
C1278039 (UMLS CUI [4])
C0008370 (UMLS CUI [5])
C0523465 (UMLS CUI [6])
C3150119 (UMLS CUI [7])
C0948762 (UMLS CUI [8])
C0032181 (UMLS CUI [9])
C0525032 (UMLS CUI [10])
Heart Disease New York Heart Association Classification | Lung disease New York Heart Association Classification | Ventricular Ejection Fraction Echocardiography | Ventricular Ejection Fraction MUGA scan | Myocardial Infarction | Cardiac Arrhythmia Unstable Electrocardiography | Ischemia Electrocardiography
Item
significant cardiac or pulmonary disease defined by new york heart association (nyha) class iii or iv, vef <50% by echo or muga, or a history of myocardial infarction within the past 6 months, significant unstable arrhythmia or evidence of ischemia on ecg
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0042508 (UMLS CUI [3,1])
C0013516 (UMLS CUI [3,2])
C0042508 (UMLS CUI [4,1])
C0521317 (UMLS CUI [4,2])
C0027051 (UMLS CUI [5])
C0003811 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C1623258 (UMLS CUI [6,3])
C0022116 (UMLS CUI [7,1])
C1623258 (UMLS CUI [7,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
Item
pregnant or nursing women. note: women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C2985296 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C0036899 (UMLS CUI [7])
Communicable Disease | HIV Infection | Requirement Anti-infective therapy Oral | Requirement Anti-infective therapy Parenteral
Item
significant active infection including hiv requiring oral or parenteral anti-infective therapies;
boolean
C0009450 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C1141958 (UMLS CUI [3,2])
C1527415 (UMLS CUI [3,3])
C1514873 (UMLS CUI [4,1])
C1141958 (UMLS CUI [4,2])
C1518896 (UMLS CUI [4,3])
Investigational New Drugs
Item
use of investigational drug(s) within 4 weeks of enrollment; or,
boolean
C0013230 (UMLS CUI [1])
Pharmaceutical Preparations Arginine Depletion
Item
prior treatment with arginine depleting agent.
boolean
C0013227 (UMLS CUI [1,1])
C0003765 (UMLS CUI [1,2])
C0333668 (UMLS CUI [1,3])