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ID

44508

Beskrivning

RCT on Adjuvant TACE After Hepatectomy for HCC; ODM derived from: https://clinicaltrials.gov/show/NCT01512407

Länk

https://clinicaltrials.gov/show/NCT01512407

Nyckelord

Versioner (2)
  1. 2020-02-19 2020-02-19 -
  2. 2021-09-27 2021-09-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 september 2021

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Hepatocellular Carcinoma NCT01512407

    Engelsk

    Eligibility Hepatocellular Carcinoma NCT01512407

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    hcc patients received curative hepatectomy with negative resection margin
    Beskrivning

    Liver carcinoma | Hepatectomy Curative | Negative Surgical Margin

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2239176
    UMLS CUI [2,1]
    C0019144
    UMLS CUI [2,2]
    C1276305
    UMLS CUI [3]
    C1709157
    age from 18 to 70
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    child-pugh class a
    Beskrivning

    Child-Pugh Classification

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C4050412
    asa class i to iii
    Beskrivning

    ASA physical status class

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0578808
    ecog performance status grade 0 or 1
    Beskrivning

    ECOG performance status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients receiving concomitant local ablation or previous tace
    Beskrivning

    Local ablation therapy | Transarterial Chemoembolization Previous

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0547070
    UMLS CUI [2,1]
    C3539919
    UMLS CUI [2,2]
    C0205156
    main portal vein tumour thrombus extraction during hepatectomy
    Beskrivning

    Main portal vein Tumor thrombus Extraction | Hepatectomy

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1183135
    UMLS CUI [1,2]
    C3163918
    UMLS CUI [1,3]
    C0185115
    UMLS CUI [2]
    C0019144
    tumour arising from caudate lobe
    Beskrivning

    Tumor Origin Caudate lobe

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0027651
    UMLS CUI [1,2]
    C0439659
    UMLS CUI [1,3]
    C0227489
    presence of extra-hepatic disease
    Beskrivning

    Disease Extrahepatic

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C1517058
    very early hcc with solitary tumour and size < 2cm
    Beskrivning

    Very Early Hepatocellular Carcinoma | Single tumor | Tumor size

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3273019
    UMLS CUI [1,2]
    C0442824
    UMLS CUI [2]
    C1298180
    UMLS CUI [3]
    C0475440
    impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin < 25g/l or bilirubin > 50micromol/l
    Beskrivning

    Liver Dysfunction | Ascites | Hepatic Encephalopathy | Serum albumin measurement | Serum total bilirubin measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0086565
    UMLS CUI [2]
    C0003962
    UMLS CUI [3]
    C0019151
    UMLS CUI [4]
    C0523465
    UMLS CUI [5]
    C1278039
    renal impairment with creatinine > 200micromol/l
    Beskrivning

    Renal Insufficiency | Creatinine measurement, serum

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1565489
    UMLS CUI [2]
    C0201976
    severe concurrent medical illness persisting > 6 weeks after hepatectomy
    Beskrivning

    Comorbidity Severe Persistent | Status post Hepatectomy

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C0205322
    UMLS CUI [2,1]
    C0231290
    UMLS CUI [2,2]
    C0019144
    history of other cancer
    Beskrivning

    Cancer Other

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1707251
    hepatic artery anomaly making tace not possible
    Beskrivning

    Hepatic artery Abnormality | Transarterial Chemoembolization Unsuccessful

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0019145
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [2,1]
    C3539919
    UMLS CUI [2,2]
    C1272705
    allergy to cisplatin or lipiodol
    Beskrivning

    Cisplatin allergy | Hypersensitivity Lipiodol

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0570702
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0947677
    pregnant woman
    Beskrivning

    Pregnancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    informed consent not available
    Beskrivning

    Informed Consent Unavailable

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0686905
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    Similar models

    Eligibility Hepatocellular Carcinoma NCT01512407

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Liver carcinoma | Hepatectomy Curative | Negative Surgical Margin
    Item
    hcc patients received curative hepatectomy with negative resection margin
    boolean
    C2239176 (UMLS CUI [1])
    C0019144 (UMLS CUI [2,1])
    C1276305 (UMLS CUI [2,2])
    C1709157 (UMLS CUI [3])
    Age
    Item
    age from 18 to 70
    boolean
    C0001779 (UMLS CUI [1])
    Child-Pugh Classification
    Item
    child-pugh class a
    boolean
    C4050412 (UMLS CUI [1])
    ASA physical status class
    Item
    asa class i to iii
    boolean
    C0578808 (UMLS CUI [1])
    ECOG performance status
    Item
    ecog performance status grade 0 or 1
    boolean
    C1520224 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Local ablation therapy | Transarterial Chemoembolization Previous
    Item
    patients receiving concomitant local ablation or previous tace
    boolean
    C0547070 (UMLS CUI [1])
    C3539919 (UMLS CUI [2,1])
    C0205156 (UMLS CUI [2,2])
    Main portal vein Tumor thrombus Extraction | Hepatectomy
    Item
    main portal vein tumour thrombus extraction during hepatectomy
    boolean
    C1183135 (UMLS CUI [1,1])
    C3163918 (UMLS CUI [1,2])
    C0185115 (UMLS CUI [1,3])
    C0019144 (UMLS CUI [2])
    Tumor Origin Caudate lobe
    Item
    tumour arising from caudate lobe
    boolean
    C0027651 (UMLS CUI [1,1])
    C0439659 (UMLS CUI [1,2])
    C0227489 (UMLS CUI [1,3])
    Disease Extrahepatic
    Item
    presence of extra-hepatic disease
    boolean
    C0012634 (UMLS CUI [1,1])
    C1517058 (UMLS CUI [1,2])
    Very Early Hepatocellular Carcinoma | Single tumor | Tumor size
    Item
    very early hcc with solitary tumour and size < 2cm
    boolean
    C3273019 (UMLS CUI [1,1])
    C0442824 (UMLS CUI [1,2])
    C1298180 (UMLS CUI [2])
    C0475440 (UMLS CUI [3])
    Liver Dysfunction | Ascites | Hepatic Encephalopathy | Serum albumin measurement | Serum total bilirubin measurement
    Item
    impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin < 25g/l or bilirubin > 50micromol/l
    boolean
    C0086565 (UMLS CUI [1])
    C0003962 (UMLS CUI [2])
    C0019151 (UMLS CUI [3])
    C0523465 (UMLS CUI [4])
    C1278039 (UMLS CUI [5])
    Renal Insufficiency | Creatinine measurement, serum
    Item
    renal impairment with creatinine > 200micromol/l
    boolean
    C1565489 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    Comorbidity Severe Persistent | Status post Hepatectomy
    Item
    severe concurrent medical illness persisting > 6 weeks after hepatectomy
    boolean
    C0009488 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0205322 (UMLS CUI [1,3])
    C0231290 (UMLS CUI [2,1])
    C0019144 (UMLS CUI [2,2])
    Cancer Other
    Item
    history of other cancer
    boolean
    C1707251 (UMLS CUI [1])
    Hepatic artery Abnormality | Transarterial Chemoembolization Unsuccessful
    Item
    hepatic artery anomaly making tace not possible
    boolean
    C0019145 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C3539919 (UMLS CUI [2,1])
    C1272705 (UMLS CUI [2,2])
    Cisplatin allergy | Hypersensitivity Lipiodol
    Item
    allergy to cisplatin or lipiodol
    boolean
    C0570702 (UMLS CUI [1])
    C0020517 (UMLS CUI [2,1])
    C0947677 (UMLS CUI [2,2])
    Pregnancy
    Item
    pregnant woman
    boolean
    C0032961 (UMLS CUI [1])
    Informed Consent Unavailable
    Item
    informed consent not available
    boolean
    C0021430 (UMLS CUI [1,1])
    C0686905 (UMLS CUI [1,2])
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