ID

20997

Beskrivning

Etoposide, Oxaliplatin and Capecitabine in Advanced Hepatocellular Carcinoma (HCC); ODM derived from: https://clinicaltrials.gov/show/NCT00351195

Länk

https://clinicaltrials.gov/show/NCT00351195

Nyckelord

Versioner (1)
  1. 2017-04-02 2017-04-02 -
Uppladdad den

2 april 2017

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.

Tillbaka till modellkommentarer
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 NCT00351195

Engelsk

Eligibility Hepatocellular Carcinoma NCT00351195

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically verified intra- or extrahepatic inoperable hepatocellular carcinoma or hyperdense liver lesion at computed tomography and concurrent elevated alpha-feto-protein > 400 ng/ml
Beskrivning

Liver carcinoma Inoperable intrahepatic | Liver carcinoma Inoperable Extrahepatic | Lesion of liver Dense X-Ray Computed Tomography | Elevated alpha-fetoprotein

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0205187
UMLS CUI [1,3]
C1512948
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0205187
UMLS CUI [2,3]
C1517058
UMLS CUI [3,1]
C0577053
UMLS CUI [3,2]
C0439794
UMLS CUI [3,3]
C0040405
UMLS CUI [4]
C0235971
ps 0-2
Beskrivning

performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1518965
age 18-75
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy > 12 weeks
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
normal bone marrow function (neutrophiles > 1,5 x 109/l and platelets > 100 x 109/l)
Beskrivning

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
bilirubin < 2 x unl
Beskrivning

Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
transaminases < 3 x unl
Beskrivning

Transaminases

Datatyp

boolean

Alias
UMLS CUI [1]
C0002594
normal renal function, cr-edta clearance > 50 ml/min
Beskrivning

Renal function | EDTA Clearance

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C3639405
no chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
Beskrivning

Chemotherapy Absent | Therapeutic radiology procedure Absent | Immunotherapy Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0332197
no uncontrolled, severe concurrent medical disease
Beskrivning

Comorbidity Severe Uncontrolled Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205318
UMLS CUI [1,4]
C0332197
fertile women must have a negative pregnancy test
Beskrivning

Childbearing Potential Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
fertile women must use adequate contraceptives during and 3 months after trial exposure
Beskrivning

Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
signed informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
Beskrivning

Chemotherapy | Therapeutic radiology procedure | Immunotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
experimental therapy < 8 weeks prior to inclusion
Beskrivning

Therapy, Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C0949266
known dpd-deficiency
Beskrivning

Dihydropyrimidine Dehydrogenase Deficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C1959620
known neuropathy
Beskrivning

Neuropathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0442874
uncontrolled, severe concurrent medical disease
Beskrivning

Comorbidity Severe Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205318
prior malignancy during the last 5 years, except for non-melanoma skin cancer and carcinoma in situ cervix uteri.
Beskrivning

Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0851140
Tillbaka till toppen

Similar models

Eligibility Hepatocellular Carcinoma NCT00351195

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma Inoperable intrahepatic | Liver carcinoma Inoperable Extrahepatic | Lesion of liver Dense X-Ray Computed Tomography | Elevated alpha-fetoprotein
Item
histologically verified intra- or extrahepatic inoperable hepatocellular carcinoma or hyperdense liver lesion at computed tomography and concurrent elevated alpha-feto-protein > 400 ng/ml
boolean
C2239176 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C1512948 (UMLS CUI [1,3])
C2239176 (UMLS CUI [2,1])
C0205187 (UMLS CUI [2,2])
C1517058 (UMLS CUI [2,3])
C0577053 (UMLS CUI [3,1])
C0439794 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C0235971 (UMLS CUI [4])
performance status
Item
ps 0-2
boolean
C1518965 (UMLS CUI [1])
Age
Item
age 18-75
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 12 weeks
boolean
C0023671 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
Item
normal bone marrow function (neutrophiles > 1,5 x 109/l and platelets > 100 x 109/l)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Serum total bilirubin measurement
Item
bilirubin < 2 x unl
boolean
C1278039 (UMLS CUI [1])
Transaminases
Item
transaminases < 3 x unl
boolean
C0002594 (UMLS CUI [1])
Renal function | EDTA Clearance
Item
normal renal function, cr-edta clearance > 50 ml/min
boolean
C0232804 (UMLS CUI [1])
C3639405 (UMLS CUI [2])
Chemotherapy Absent | Therapeutic radiology procedure Absent | Immunotherapy Absent
Item
no chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Comorbidity Severe Uncontrolled Absent
Item
no uncontrolled, severe concurrent medical disease
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Childbearing Potential Pregnancy test negative
Item
fertile women must have a negative pregnancy test
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods
Item
fertile women must use adequate contraceptives during and 3 months after trial exposure
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure | Immunotherapy
Item
chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
Therapy, Investigational
Item
experimental therapy < 8 weeks prior to inclusion
boolean
C0949266 (UMLS CUI [1])
Dihydropyrimidine Dehydrogenase Deficiency
Item
known dpd-deficiency
boolean
C1959620 (UMLS CUI [1])
Neuropathy
Item
known neuropathy
boolean
C0442874 (UMLS CUI [1])
Comorbidity Severe Uncontrolled
Item
uncontrolled, severe concurrent medical disease
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix
Item
prior malignancy during the last 5 years, except for non-melanoma skin cancer and carcinoma in situ cervix uteri.
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
Tillbaka till toppen 

Kontakt

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

Fält markerade med * är obligatoriska.

Hjälp

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