ID

44066

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00858871

Palabras clave

  1. 18/4/18 18/4/18 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Hepato Cellular Carcinoma (HCC) NCT00858871

Eligibility Hepato Cellular Carcinoma (HCC) NCT00858871

Criteria
Descripción

Criteria

Inclusion Criteria
Descripción

Inclusion Criteria

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

Liver carcinoma

Tipo de datos

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
Descripción

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 datos

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
Descripción

Child-Pugh Classification

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4050412
ecog performance status 0-1
Descripción

ECOG performance status

Tipo de datos

boolean

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

Hematologic function | Liver function | Renal function

Tipo de datos

boolean

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

Exclusion Criteria

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

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

Tipo de datos

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
Descripción

Heart Disease

Tipo de datos

boolean

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

Event Thrombotic | Event Embolic | Exception Liver carcinoma Thrombus

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Lacking Able to swallow Tablets | Malabsorption Syndrome untreated

Tipo de datos

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

Similar models

Eligibility Hepato Cellular Carcinoma (HCC) NCT00858871

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
C4050412 (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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