ID

29823

Beskrivning

Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01008358

Länk

https://clinicaltrials.gov/show/NCT01008358

Nyckelord

  1. 2018-04-21 2018-04-21 -
  2. 2018-04-21 2018-04-21 -
  3. 2018-04-22 2018-04-22 -
  4. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 april 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Hepatocellular Carcinoma NCT01008358

Eligibility Hepatocellular Carcinoma NCT01008358

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
unequivocal diagnosis of hcc
Beskrivning

Liver carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
unresectable disease not amenable to locoregional treatment.
Beskrivning

Disease unresectable | Disease Inappropriate Therapeutic procedure Locoregional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519810
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C1947913
a 4-week washout period after sorafenib or any other systemic agent
Beskrivning

Washout Period Post Sorafenib | Washout Period Post Pharmaceutical Preparations Systemic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1710661
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C1516119
UMLS CUI [2,1]
C1710661
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0013227
UMLS CUI [2,4]
C0205373
a 2-month washout period after internal or external radiation
Beskrivning

Washout Period Post Brachytherapy | Washout Period Post External Radiation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1710661
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0006098
UMLS CUI [2,1]
C1710661
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C1517033
hcv chronic infection
Beskrivning

Hepatitis C, Chronic

Datatyp

boolean

Alias
UMLS CUI [1]
C0524910
child-pugh stage a or b
Beskrivning

Child-Pugh Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C2347612
measurable disease according to recist criteria
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
ecog < 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
expected survival > 3 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
adequate liver, renal and blood functions
Beskrivning

Liver function | Renal function | Hematologic function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0221130
ability to sign informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with an anti-ctl-4 agent
Beskrivning

CTL4 inhibitors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3711064
UMLS CUI [1,2]
C0243077
serious infections or disease compromising general health status
Beskrivning

Communicable Disease Serious compromises General health | Disease Serious compromises General health

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C0424575
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C0424575
autoimmune disease that requires therapy
Beskrivning

Autoimmune Disease Treatment required for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0332121
treatment with immunosuppressors
Beskrivning

Immunosuppressive Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0021081
treatment with investigational agents
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
other neoplasms except skin and bladder superficial tumors
Beskrivning

Cancer Other | Exception Skin carcinoma | Exception Bladder Neoplasm Superficial

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0005695
UMLS CUI [3,3]
C0205124
pregnancy or lactation
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
snc metastasis
Beskrivning

CNS metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
hiv infection
Beskrivning

HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
relevant heart disease (nyha class iii or iv)
Beskrivning

Heart Disease New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491

Similar models

Eligibility Hepatocellular Carcinoma NCT01008358

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma
Item
unequivocal diagnosis of hcc
boolean
C2239176 (UMLS CUI [1])
Disease unresectable | Disease Inappropriate Therapeutic procedure Locoregional
Item
unresectable disease not amenable to locoregional treatment.
boolean
C0012634 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1947913 (UMLS CUI [2,4])
Washout Period Post Sorafenib | Washout Period Post Pharmaceutical Preparations Systemic
Item
a 4-week washout period after sorafenib or any other systemic agent
boolean
C1710661 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1516119 (UMLS CUI [1,3])
C1710661 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C0205373 (UMLS CUI [2,4])
Washout Period Post Brachytherapy | Washout Period Post External Radiation
Item
a 2-month washout period after internal or external radiation
boolean
C1710661 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0006098 (UMLS CUI [1,3])
C1710661 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C1517033 (UMLS CUI [2,3])
Hepatitis C, Chronic
Item
hcv chronic infection
boolean
C0524910 (UMLS CUI [1])
Child-Pugh Classification
Item
child-pugh stage a or b
boolean
C2347612 (UMLS CUI [1])
Measurable Disease
Item
measurable disease according to recist criteria
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
ecog < 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
expected survival > 3 months
boolean
C0023671 (UMLS CUI [1])
Liver function | Renal function | Hematologic function
Item
adequate liver, renal and blood functions
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0221130 (UMLS CUI [3])
Informed Consent
Item
ability to sign informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CTL4 inhibitors
Item
previous treatment with an anti-ctl-4 agent
boolean
C3711064 (UMLS CUI [1,1])
C0243077 (UMLS CUI [1,2])
Communicable Disease Serious compromises General health | Disease Serious compromises General health
Item
serious infections or disease compromising general health status
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C0424575 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C0424575 (UMLS CUI [2,4])
Autoimmune Disease Treatment required for
Item
autoimmune disease that requires therapy
boolean
C0004364 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Immunosuppressive Agents
Item
treatment with immunosuppressors
boolean
C0021081 (UMLS CUI [1])
Investigational New Drugs
Item
treatment with investigational agents
boolean
C0013230 (UMLS CUI [1])
Cancer Other | Exception Skin carcinoma | Exception Bladder Neoplasm Superficial
Item
other neoplasms except skin and bladder superficial tumors
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0005695 (UMLS CUI [3,2])
C0205124 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
CNS metastases
Item
snc metastasis
boolean
C0686377 (UMLS CUI [1])
HIV Infection
Item
hiv infection
boolean
C0019693 (UMLS CUI [1])
Heart Disease New York Heart Association Classification
Item
relevant heart disease (nyha class iii or iv)
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial