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ID

15338

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02409524

Nyckelord

  1. 2016-05-27 2016-05-27 -
Uppladdad den

27 maj 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Advanced Adult Hepatocellular Carcinoma NCT02409524

    Eligibility Advanced Adult Hepatocellular Carcinoma NCT02409524

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

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

    age

    Datatyp

    boolean

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

    hepatocellular carcinoma

    Datatyp

    boolean

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

    sorafenib

    Datatyp

    boolean

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

    child-pugh stage

    Datatyp

    boolean

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

    ecog

    Datatyp

    boolean

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

    measurable disease

    Datatyp

    boolean

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

    percutaneous tumor harvest

    Datatyp

    boolean

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

    hemoglobin

    Datatyp

    boolean

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

    absolute neutrophil count

    Datatyp

    boolean

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

    platelet count

    Datatyp

    boolean

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

    alt and ast

    Datatyp

    boolean

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

    alkaline phosphatase

    Datatyp

    boolean

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

    serum creatinine

    Datatyp

    boolean

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

    negative pregnancy test

    Datatyp

    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
    Beskrivning

    contraception or avoidance of pregnancy

    Datatyp

    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
    Beskrivning

    informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

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

    ascites

    Datatyp

    boolean

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

    encephalopathy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0085584
    inr > 1.5
    Beskrivning

    inr

    Datatyp

    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
    Beskrivning

    participation in another clinical trial

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    any autoimmune disorder
    Beskrivning

    autoimmune disorder

    Datatyp

    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
    Beskrivning

    systemic steroids or current immunosuppressive therapy

    Datatyp

    boolean

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

    hiv positive or syphilis

    Datatyp

    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
    Beskrivning

    cardiac disease

    Datatyp

    boolean

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

    infections

    Datatyp

    boolean

    history of organ or tissue allograft
    Beskrivning

    history of organ or tissue allograft

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0040739
    advanced liver cirrhosis
    Beskrivning

    liver cirrhosis

    Datatyp

    boolean

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

    interferon or thalidomide

    Datatyp

    boolean

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

    uncontrolled concurrent serious medical or psychiatric illness

    Datatyp

    boolean

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

    central nervous system metastases, Meningeal Carcinomatosis

    Datatyp

    boolean

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

    history of blood transfusion reactions

    Datatyp

    boolean

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

    allergy to murine monoclonal antibodies

    Datatyp

    boolean

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

    Similar models

    Eligibility Advanced Adult Hepatocellular Carcinoma NCT02409524

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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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