ID

29746

Descrição

First Line Hepato Cellular Carcinoma (HCC); ODM derived from: https://clinicaltrials.gov/show/NCT00858871

Link

https://clinicaltrials.gov/show/NCT00858871

Palavras-chave

Versões (2)
  1. 18/04/2018 18/04/2018 -
  2. 20/09/2021 20/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

18 de abril de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hepato Cellular Carcinoma (HCC) NCT00858871

Inglês

Eligibility Hepato Cellular Carcinoma (HCC) NCT00858871

1 Formulários  
Criteria
Descrição

Criteria

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic or cytologic confirmed diagnosis of hcc.
Descrição

Liver carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2239176
advanced hcc: disease not eligible for surgical and/or locoregional therapies or progressive disease after surgical and/or locoregional therapies
Descrição

Liver carcinoma Advanced | Disease Inappropriate Operative Surgical Procedures | Disease Inappropriate Therapeutic procedure Locoregional | Progressive Disease Post Operative Surgical Procedures | Progressive Disease Post Therapeutic procedure Locoregional

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0543467
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C0087111
UMLS CUI [3,4]
C1947913
UMLS CUI [4,1]
C1335499
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C0543467
UMLS CUI [5,1]
C1335499
UMLS CUI [5,2]
C0687676
UMLS CUI [5,3]
C0087111
UMLS CUI [5,4]
C1947913
child-pugh class a
Descrição

Child-Pugh Classification

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2347612
ecog performance status 0-1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematologic, hepatic, and renal function
Descrição

Hematologic function | Liver function | Renal function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for hcc
Descrição

Systemic Chemotherapy Liver carcinoma | Immunotherapy Liver carcinoma | Molecular Targeted Therapy Liver carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C2239176
UMLS CUI [2,1]
C0021083
UMLS CUI [2,2]
C2239176
UMLS CUI [3,1]
C2699893
UMLS CUI [3,2]
C2239176
history of active cardiac disease
Descrição

Heart Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018799
thrombotic or embolic events within the past 6 months (except hcc tumor thrombus)
Descrição

Event Thrombotic | Event Embolic | Exception Liver carcinoma Thrombus

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0087086
UMLS CUI [2,1]
C0441471
UMLS CUI [2,2]
C0013922
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2239176
UMLS CUI [3,3]
C0087086
any other hemorrhage/bleeding event >= ctcae grade 3 within 8 weeks except for esophageal or gastric varices
Descrição

Other Hemorrhage and Bleeding Adverse Event CTCAE Grades | Exception Bleeding esophageal varices | Exception Bleeding gastric varices

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1556642
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0155789
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0267209
inability to swallow tablets or untreated malabsorption syndrome
Descrição

Lacking Able to swallow Tablets | Malabsorption Syndrome untreated

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0039225
UMLS CUI [2,1]
C0024523
UMLS CUI [2,2]
C0332155
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Similar models

Eligibility Hepato Cellular Carcinoma (HCC) NCT00858871

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Liver carcinoma
Item
histologic or cytologic confirmed diagnosis of hcc.
boolean
C2239176 (UMLS CUI [1])
Liver carcinoma Advanced | Disease Inappropriate Operative Surgical Procedures | Disease Inappropriate Therapeutic procedure Locoregional | Progressive Disease Post Operative Surgical Procedures | Progressive Disease Post Therapeutic procedure Locoregional
Item
advanced hcc: disease not eligible for surgical and/or locoregional therapies or progressive disease after surgical and/or locoregional therapies
boolean
C2239176 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C1947913 (UMLS CUI [3,4])
C1335499 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C0543467 (UMLS CUI [4,3])
C1335499 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
C0087111 (UMLS CUI [5,3])
C1947913 (UMLS CUI [5,4])
Child-Pugh Classification
Item
child-pugh class a
boolean
C2347612 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Liver function | Renal function
Item
adequate hematologic, hepatic, and renal function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Systemic Chemotherapy Liver carcinoma | Immunotherapy Liver carcinoma | Molecular Targeted Therapy Liver carcinoma
Item
prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for hcc
boolean
C1883256 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
C2699893 (UMLS CUI [3,1])
C2239176 (UMLS CUI [3,2])
Heart Disease
Item
history of active cardiac disease
boolean
C0018799 (UMLS CUI [1])
Event Thrombotic | Event Embolic | Exception Liver carcinoma Thrombus
Item
thrombotic or embolic events within the past 6 months (except hcc tumor thrombus)
boolean
C0441471 (UMLS CUI [1,1])
C0087086 (UMLS CUI [1,2])
C0441471 (UMLS CUI [2,1])
C0013922 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2239176 (UMLS CUI [3,2])
C0087086 (UMLS CUI [3,3])
Other Hemorrhage and Bleeding Adverse Event CTCAE Grades | Exception Bleeding esophageal varices | Exception Bleeding gastric varices
Item
any other hemorrhage/bleeding event >= ctcae grade 3 within 8 weeks except for esophageal or gastric varices
boolean
C1556642 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0155789 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0267209 (UMLS CUI [3,2])
Lacking Able to swallow Tablets | Malabsorption Syndrome untreated
Item
inability to swallow tablets or untreated malabsorption syndrome
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,3])
C0024523 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
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