ID

39754

Beschrijving

Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response; ODM derived from: https://clinicaltrials.gov/show/NCT01128803

Link

https://clinicaltrials.gov/show/NCT01128803

Trefwoorden

Versies (1)
  1. 16-02-20 16-02-20 -
Houder van rechten

See clinicaltrials.gov

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16 februari 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01128803

Engels

Eligibility Hepatocellular Carcinoma NCT01128803

1 Formulieren  
Criteria
Beschrijving

Criteria

adults (men or women) aged between 18 and 80 years
Beschrijving

Adult | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
patients affiliated to a social security reimbursement system
Beschrijving

Patients Affiliated Social security system

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1510826
UMLS CUI [1,3]
C2371809
signed informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
hepatocellular carcinoma
Beschrijving

Liver carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C2239176
at least one dosage with alpha-foeto-protein ≥ 40 ng/ml
Beschrijving

Alpha one fetoprotein measurement Dosage Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0201539
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
patient already treated with chemoembolization, percutaneous destruction (alcohol or radiofrequency), surgery or sorafenib.
Beschrijving

Chemoembolization | Destruction Percutaneous | Radiofrequency destruction | Operative Surgical Procedures | sorafenib

Datatype

boolean

Alias
UMLS CUI [1]
C0796679
UMLS CUI [2,1]
C1261381
UMLS CUI [2,2]
C0522523
UMLS CUI [3]
C0441517
UMLS CUI [4]
C0543467
UMLS CUI [5]
C1516119
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
negative test for pregnancy or effective contraception
Beschrijving

Pregnancy test negative | Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
UMLS CUI [2]
C0700589
patient hiv-, hep b-, hep c-, htlv1 and 2-, syphilis-
Beschrijving

HIV | Hepatitis B | Hepatitis C | Human T-lymphotropic virus 1 | Human T-lymphotropic virus 2 | Syphilis

Datatype

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0020094
UMLS CUI [5]
C0020099
UMLS CUI [6]
C0039128
hla a 0201 group
Beschrijving

HLA-A*02:01 antigen Group

Datatype

boolean

Alias
UMLS CUI [1,1]
C1097566
UMLS CUI [1,2]
C0441833
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
life expectancy < 3 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
pregnancy or breast-feeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
severe auto-immune disease
Beschrijving

Autoimmune Disease Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0205082
another malignant tumor except if considered as cured since more than 5 years
Beschrijving

Cancer Other | Exception Malignant Neoplasm Cured Duration

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C1880198
UMLS CUI [2,4]
C0449238
history of uncontrolled psychiatric condition
Beschrijving

Mental disorders Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205318
risk factors of creutzfeldt jacobs disease
Beschrijving

Risk factors Creutzfeldt-Jakob disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0022336
decompensated cirrhosis(ascites or child-pugh score greater than 8)
Beschrijving

Decompensated cirrhosis of liver | Ascites | Child-Pugh - Total Score

Datatype

boolean

Alias
UMLS CUI [1]
C1619727
UMLS CUI [2]
C0003962
UMLS CUI [3]
C4055253
hepatic transplantation
Beschrijving

Transplantation of liver

Datatype

boolean

Alias
UMLS CUI [1]
C0023911
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Similar models

Eligibility Hepatocellular Carcinoma NCT01128803

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Adult | Age
Item
adults (men or women) aged between 18 and 80 years
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Patients Affiliated Social security system
Item
patients affiliated to a social security reimbursement system
boolean
C0030705 (UMLS CUI [1,1])
C1510826 (UMLS CUI [1,2])
C2371809 (UMLS CUI [1,3])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Liver carcinoma
Item
hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
Alpha one fetoprotein measurement Dosage Quantity
Item
at least one dosage with alpha-foeto-protein ≥ 40 ng/ml
boolean
C0201539 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Chemoembolization | Destruction Percutaneous | Radiofrequency destruction | Operative Surgical Procedures | sorafenib
Item
patient already treated with chemoembolization, percutaneous destruction (alcohol or radiofrequency), surgery or sorafenib.
boolean
C0796679 (UMLS CUI [1])
C1261381 (UMLS CUI [2,1])
C0522523 (UMLS CUI [2,2])
C0441517 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
C1516119 (UMLS CUI [5])
Item Group
C1512693 (UMLS CUI)
Pregnancy test negative | Contraceptive methods
Item
negative test for pregnancy or effective contraception
boolean
C0427780 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
HIV | Hepatitis B | Hepatitis C | Human T-lymphotropic virus 1 | Human T-lymphotropic virus 2 | Syphilis
Item
patient hiv-, hep b-, hep c-, htlv1 and 2-, syphilis-
boolean
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0020094 (UMLS CUI [4])
C0020099 (UMLS CUI [5])
C0039128 (UMLS CUI [6])
HLA-A*02:01 antigen Group
Item
hla a 0201 group
boolean
C1097566 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Life Expectancy
Item
life expectancy < 3 months
boolean
C0023671 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Autoimmune Disease Severe
Item
severe auto-immune disease
boolean
C0004364 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Cancer Other | Exception Malignant Neoplasm Cured Duration
Item
another malignant tumor except if considered as cured since more than 5 years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
Mental disorders Uncontrolled
Item
history of uncontrolled psychiatric condition
boolean
C0004936 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Risk factors Creutzfeldt-Jakob disease
Item
risk factors of creutzfeldt jacobs disease
boolean
C0035648 (UMLS CUI [1,1])
C0022336 (UMLS CUI [1,2])
Decompensated cirrhosis of liver | Ascites | Child-Pugh - Total Score
Item
decompensated cirrhosis(ascites or child-pugh score greater than 8)
boolean
C1619727 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C4055253 (UMLS CUI [3])
Transplantation of liver
Item
hepatic transplantation
boolean
C0023911 (UMLS CUI [1])
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