ID

15338

Description

An Individualized Anti-Cancer Vaccine in Advanced Hepatocellular Carcinoma Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT02409524

Link

https://clinicaltrials.gov/show/NCT02409524

Keywords

Versions (1)
  1. 5/27/16 5/27/16 -
Uploaded on

May 27, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Advanced Adult Hepatocellular Carcinoma NCT02409524

English

Eligibility Advanced Adult Hepatocellular Carcinoma NCT02409524

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females who are at least 18 years of age at time of enrollment
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed hepatocellular carcinoma with or without positive hbv and/or hcv
Description

hepatocellular carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
minimum of 90 days of sorafenib treatment and unresectable
Description

sorafenib

Data type

boolean

Alias
UMLS CUI [1]
C1516119
child-pugh stage a-b (score ≥ 5 and ≤ 9)
Description

child-pugh stage

Data type

boolean

Alias
UMLS CUI [1]
C4050412
performance status: ecog < 2 with no deterioration over the previous 2 weeks
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
measurable disease (for recist)
Description

measurable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
lesion amenable for percutaneous tumor harvest and follow up biopsy
Description

percutaneous tumor harvest

Data type

boolean

Alias
UMLS CUI [1]
C0522523
hemoglobin > 10.0 g/dl
Description

hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0019046
absolute neutrophil count (anc) > 1,500/mm3
Description

absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count > 75,000/μl
Description

platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0032181
alt and ast < 2.5 x uln
Description

alt and ast

Data type

boolean

Alias
UMLS CUI [1]
C0001899
UMLS CUI [2]
C0004002
alkaline phosphatase < 4 x uln
Description

alkaline phosphatase

Data type

boolean

Alias
UMLS CUI [1]
C0201850
serum creatinine < 1.5
Description

serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
women of child-bearing potential: negative pregnancy test
Description

negative pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0427780
patients of child producing potential: usage of contraception or avoidance of pregnancy measures while enrolled on study and receiving the experimental product
Description

contraception or avoidance of pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C1821946
ability to understand the study, its inherent risks, side effects and potential benefits and ability to give written informed consent to participate
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe ascites, massive or uncontrolled (+3 on child-pugh calculator)
Description

ascites

Data type

boolean

Alias
UMLS CUI [1]
C0003962
severe encephalopathy, uncontrolled (+3 on child-pugh calculator)
Description

encephalopathy

Data type

boolean

Alias
UMLS CUI [1]
C0085584
inr > 1.5
Description

inr

Data type

boolean

Alias
UMLS CUI [1]
C0482691
participation in another clinical trial evaluating experimental treatments or procedures or receiving medication/treatment for hcc other than sorafenib
Description

participation in another clinical trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
any autoimmune disorder
Description

autoimmune disorder

Data type

boolean

Alias
UMLS CUI [1]
C0004364
any clinical condition requiring systemic steroids or current immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 1 month of study entry
Description

systemic steroids or current immunosuppressive therapy

Data type

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2]
C0021079
hiv positive or syphilis
Description

hiv positive or syphilis

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0039128
history of cardiac disease: congestive heart failure > nyha class 2; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
Description

cardiac disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
active clinically serious infections (> grade 2 nci-ctcae version 4.0)
Description

infections

Data type

boolean

history of organ or tissue allograft
Description

history of organ or tissue allograft

Data type

boolean

Alias
UMLS CUI [1]
C0040739
advanced liver cirrhosis
Description

liver cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
interferon or thalidomide within 1 month prior to signing informed consent
Description

interferon or thalidomide

Data type

boolean

Alias
UMLS CUI [1]
C0039736
UMLS CUI [2]
C0021747
uncontrolled concurrent serious medical or psychiatric illness
Description

uncontrolled concurrent serious medical or psychiatric illness

Data type

boolean

Alias
UMLS CUI [1,1]
C0205420
UMLS CUI [1,2]
C0418964
clinically apparent central nervous system metastases or carcinomatous meningitis
Description

central nervous system metastases, Meningeal Carcinomatosis

Data type

boolean

Alias
UMLS CUI [1]
C0279130
UMLS CUI [2]
C0220654
history of blood transfusion reactions
Description

history of blood transfusion reactions

Data type

boolean

Alias
UMLS CUI [1]
C0274435
known allergy to murine monoclonal antibodies or bovine products or cow milk
Description

allergy to murine monoclonal antibodies

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2916903
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0349374
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Similar models

Eligibility Advanced Adult Hepatocellular Carcinoma NCT02409524

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
males and females who are at least 18 years of age at time of enrollment
boolean
C0001779 (UMLS CUI [1])
hepatocellular carcinoma
Item
histologically confirmed hepatocellular carcinoma with or without positive hbv and/or hcv
boolean
C2239176 (UMLS CUI [1])
sorafenib
Item
minimum of 90 days of sorafenib treatment and unresectable
boolean
C1516119 (UMLS CUI [1])
child-pugh stage
Item
child-pugh stage a-b (score ≥ 5 and ≤ 9)
boolean
C4050412 (UMLS CUI [1])
ecog
Item
performance status: ecog < 2 with no deterioration over the previous 2 weeks
boolean
C1520224 (UMLS CUI [1])
measurable disease
Item
measurable disease (for recist)
boolean
C1513041 (UMLS CUI [1])
percutaneous tumor harvest
Item
lesion amenable for percutaneous tumor harvest and follow up biopsy
boolean
C0522523 (UMLS CUI [1])
hemoglobin
Item
hemoglobin > 10.0 g/dl
boolean
C0019046 (UMLS CUI [1])
absolute neutrophil count
Item
absolute neutrophil count (anc) > 1,500/mm3
boolean
C0948762 (UMLS CUI [1])
platelet count
Item
platelet count > 75,000/μl
boolean
C0032181 (UMLS CUI [1])
alt and ast
Item
alt and ast < 2.5 x uln
boolean
C0001899 (UMLS CUI [1])
C0004002 (UMLS CUI [2])
alkaline phosphatase
Item
alkaline phosphatase < 4 x uln
boolean
C0201850 (UMLS CUI [1])
serum creatinine
Item
serum creatinine < 1.5
boolean
C0201976 (UMLS CUI [1])
negative pregnancy test
Item
women of child-bearing potential: negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
contraception or avoidance of pregnancy
Item
patients of child producing potential: usage of contraception or avoidance of pregnancy measures while enrolled on study and receiving the experimental product
boolean
C0700589 (UMLS CUI [1])
C1821946 (UMLS CUI [2])
informed consent
Item
ability to understand the study, its inherent risks, side effects and potential benefits and ability to give written informed consent to participate
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ascites
Item
severe ascites, massive or uncontrolled (+3 on child-pugh calculator)
boolean
C0003962 (UMLS CUI [1])
encephalopathy
Item
severe encephalopathy, uncontrolled (+3 on child-pugh calculator)
boolean
C0085584 (UMLS CUI [1])
inr
Item
inr > 1.5
boolean
C0482691 (UMLS CUI [1])
participation in another clinical trial
Item
participation in another clinical trial evaluating experimental treatments or procedures or receiving medication/treatment for hcc other than sorafenib
boolean
C2348568 (UMLS CUI [1])
autoimmune disorder
Item
any autoimmune disorder
boolean
C0004364 (UMLS CUI [1])
systemic steroids or current immunosuppressive therapy
Item
any clinical condition requiring systemic steroids or current immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 1 month of study entry
boolean
C2825233 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
hiv positive or syphilis
Item
hiv positive or syphilis
boolean
C0019699 (UMLS CUI [1])
C0039128 (UMLS CUI [2])
cardiac disease
Item
history of cardiac disease: congestive heart failure > nyha class 2; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
boolean
C0018799 (UMLS CUI [1])
infections
Item
active clinically serious infections (> grade 2 nci-ctcae version 4.0)
boolean
history of organ or tissue allograft
Item
history of organ or tissue allograft
boolean
C0040739 (UMLS CUI [1])
liver cirrhosis
Item
advanced liver cirrhosis
boolean
C0023890 (UMLS CUI [1])
interferon or thalidomide
Item
interferon or thalidomide within 1 month prior to signing informed consent
boolean
C0039736 (UMLS CUI [1])
C0021747 (UMLS CUI [2])
uncontrolled concurrent serious medical or psychiatric illness
Item
uncontrolled concurrent serious medical or psychiatric illness
boolean
C0205420 (UMLS CUI [1,1])
C0418964 (UMLS CUI [1,2])
central nervous system metastases, Meningeal Carcinomatosis
Item
clinically apparent central nervous system metastases or carcinomatous meningitis
boolean
C0279130 (UMLS CUI [1])
C0220654 (UMLS CUI [2])
history of blood transfusion reactions
Item
history of blood transfusion reactions
boolean
C0274435 (UMLS CUI [1])
allergy to murine monoclonal antibodies
Item
known allergy to murine monoclonal antibodies or bovine products or cow milk
boolean
C0020517 (UMLS CUI [1,1])
C2916903 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0349374 (UMLS CUI [2,2])
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