Informações:
Falhas:
ID
15338
Descrição
An Individualized Anti-Cancer Vaccine in Advanced Hepatocellular Carcinoma Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT02409524
Link
https://clinicaltrials.gov/show/NCT02409524
Palavras-chave
Versões (1)
- 27/05/2016 27/05/2016 -
Transferido a
27 de maio de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Advanced Adult Hepatocellular Carcinoma NCT02409524
Eligibility Advanced Adult Hepatocellular Carcinoma NCT02409524
- StudyEvent: Eligibility
Similar models
Eligibility Advanced Adult Hepatocellular Carcinoma NCT02409524
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
C0021079 (UMLS CUI [2])
hiv positive or syphilis
Item
hiv positive or syphilis
boolean
C0019699 (UMLS CUI [1])
C0039128 (UMLS CUI [2])
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])
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])
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])
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])
C2916903 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0349374 (UMLS CUI [2,2])