ID

41137

Beskrivning

SorAfenib Versus RADIOEMBOLIZATION in Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01482442

Länk

https://clinicaltrials.gov/show/NCT01482442

Nyckelord

Versioner (1)
  1. 2020-06-29 2020-06-29 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

29 juni 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Liver Carcinoma NCT01482442

Engelsk

Eligibility Liver Carcinoma NCT01482442

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological or cytological diagnosis or meet the aasld criteria for diagnosis of hcc and at least one uni-dimensional lesion measurable according to recist criteria by ct-scan or mri
Beskrivning

Liver carcinoma | Measurable lesion Linear Quantity | CT scan | MRI

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0205132
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0040405
UMLS CUI [4]
C0024485
adult over 18 years old and estimated life expectancy over 3 months
Beskrivning

Adult | Age | Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0023671
patient with advanced hcc according to bclc staging system (stage c) with or without portal vein thrombosis, not eligible for surgical resection, liver transplantation nor radiofrequency ablation or patient with progression or recurrence of hcc after surgical or locoregional treatment not eligible for surgical resection, liver transplantation nor radiofrequency ablation.
Beskrivning

Liver carcinoma Advanced BCLC Stage | Portal Vein Thrombosis | Portal Vein Thrombosis Absent | Ineligibility Excision | Ineligibility Transplantation of liver | Ineligibility Radiofrequency Ablation | Liver carcinoma Progression | Recurrent Liver Carcinoma | Status post Operative Surgical Procedure | Status post Therapy Locoregional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C3899974
UMLS CUI [2]
C0155773
UMLS CUI [3,1]
C0155773
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1512714
UMLS CUI [4,2]
C0728940
UMLS CUI [5,1]
C1512714
UMLS CUI [5,2]
C0023911
UMLS CUI [6,1]
C1512714
UMLS CUI [6,2]
C0850292
UMLS CUI [7,1]
C2239176
UMLS CUI [7,2]
C0242656
UMLS CUI [8]
C0854794
UMLS CUI [9,1]
C0231290
UMLS CUI [9,2]
C0543467
UMLS CUI [10,1]
C0231290
UMLS CUI [10,2]
C0087111
UMLS CUI [10,3]
C1947913
ecog performance status under or equals 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate haematological function: hb over or equals 9g/100ml, absolute neutrophil count over or equals 1 500/mm3, platelet count over or equals 50 000/mm3
Beskrivning

Hematologic function | Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
adequate renal function; serum creatinine under 150μmol/l
Beskrivning

Renal function | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
bilirubin under or equals 50 µmol/l, ast or alt uner or equals 5 x uln, inr under or equals 1.5
Beskrivning

Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | International Normalized Ratio

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0525032
liver cirrhosis child pugh a - b7
Beskrivning

Liver Cirrhosis Child-Pugh Clinical Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C4050412
written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia
Beskrivning

Cancer Other | Exception Basal cell carcinoma | Exception Superficial carcinoma of urinary bladder

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1336527
extrahepatic metastasis
Beskrivning

Neoplasm Metastasis Extrahepatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517058
advanced hcc previously treated
Beskrivning

Prior Therapy Liver carcinoma Advanced

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C2239176
UMLS CUI [1,3]
C0205179
advanced liver disease with child-pugh score over 7 or active gastrointestinal bleeding or encephalopathy or ascites refractory to diuretic therapy women who are pregnant or breast feeding
Beskrivning

Liver disease Advanced Child-Pugh Clinical Classification | Gastrointestinal Hemorrhage | Encephalopathy | Ascites Unresponsive to Diuretic therapy | Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C4050412
UMLS CUI [2]
C0017181
UMLS CUI [3]
C0085584
UMLS CUI [4,1]
C0003962
UMLS CUI [4,2]
C0205269
UMLS CUI [4,3]
C0948575
UMLS CUI [5]
C0032961
UMLS CUI [6]
C0006147
allergy to contrast media
Beskrivning

Contrast media allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C0570562
contraindication to hepatic artery catheterisation, such as severe peripheral vascular disease precluding catheterisation
Beskrivning

Medical contraindication Arterial catheterization Hepatic | Peripheral Vascular Disease Severe Excludes Catheterization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0007431
UMLS CUI [1,3]
C0205054
UMLS CUI [2,1]
C0085096
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332196
UMLS CUI [2,4]
C0007430
psychiatric or other disorder likely to impact on informed consent
Beskrivning

Mental disorder Impact Informed Consent | Other medical condition Impact Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C4049986
UMLS CUI [2,3]
C0021430
patient unable and/or unwilling to comply with treatment and study instructions
Beskrivning

Treatment Compliance Unable | Treatment Compliance Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4319828
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C4319828
UMLS CUI [2,2]
C0558080
patient unable to swallow oral medications
Beskrivning

Lacking Able to swallow Oral Medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0175795
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Similar models

Eligibility Liver Carcinoma NCT01482442

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma | Measurable lesion Linear Quantity | CT scan | MRI
Item
histological or cytological diagnosis or meet the aasld criteria for diagnosis of hcc and at least one uni-dimensional lesion measurable according to recist criteria by ct-scan or mri
boolean
C2239176 (UMLS CUI [1])
C1513041 (UMLS CUI [2,1])
C0205132 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0040405 (UMLS CUI [3])
C0024485 (UMLS CUI [4])
Adult | Age | Life Expectancy
Item
adult over 18 years old and estimated life expectancy over 3 months
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
Liver carcinoma Advanced BCLC Stage | Portal Vein Thrombosis | Portal Vein Thrombosis Absent | Ineligibility Excision | Ineligibility Transplantation of liver | Ineligibility Radiofrequency Ablation | Liver carcinoma Progression | Recurrent Liver Carcinoma | Status post Operative Surgical Procedure | Status post Therapy Locoregional
Item
patient with advanced hcc according to bclc staging system (stage c) with or without portal vein thrombosis, not eligible for surgical resection, liver transplantation nor radiofrequency ablation or patient with progression or recurrence of hcc after surgical or locoregional treatment not eligible for surgical resection, liver transplantation nor radiofrequency ablation.
boolean
C2239176 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C3899974 (UMLS CUI [1,3])
C0155773 (UMLS CUI [2])
C0155773 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1512714 (UMLS CUI [4,1])
C0728940 (UMLS CUI [4,2])
C1512714 (UMLS CUI [5,1])
C0023911 (UMLS CUI [5,2])
C1512714 (UMLS CUI [6,1])
C0850292 (UMLS CUI [6,2])
C2239176 (UMLS CUI [7,1])
C0242656 (UMLS CUI [7,2])
C0854794 (UMLS CUI [8])
C0231290 (UMLS CUI [9,1])
C0543467 (UMLS CUI [9,2])
C0231290 (UMLS CUI [10,1])
C0087111 (UMLS CUI [10,2])
C1947913 (UMLS CUI [10,3])
ECOG performance status
Item
ecog performance status under or equals 1
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement
Item
adequate haematological function: hb over or equals 9g/100ml, absolute neutrophil count over or equals 1 500/mm3, platelet count over or equals 50 000/mm3
boolean
C0221130 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Renal function | Creatinine measurement, serum
Item
adequate renal function; serum creatinine under 150μmol/l
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | International Normalized Ratio
Item
bilirubin under or equals 50 µmol/l, ast or alt uner or equals 5 x uln, inr under or equals 1.5
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0525032 (UMLS CUI [4])
Liver Cirrhosis Child-Pugh Clinical Classification
Item
liver cirrhosis child pugh a - b7
boolean
C0023890 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Exception Basal cell carcinoma | Exception Superficial carcinoma of urinary bladder
Item
another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1336527 (UMLS CUI [3,2])
Neoplasm Metastasis Extrahepatic
Item
extrahepatic metastasis
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
Prior Therapy Liver carcinoma Advanced
Item
advanced hcc previously treated
boolean
C1514463 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
Liver disease Advanced Child-Pugh Clinical Classification | Gastrointestinal Hemorrhage | Encephalopathy | Ascites Unresponsive to Diuretic therapy | Pregnancy | Breast Feeding
Item
advanced liver disease with child-pugh score over 7 or active gastrointestinal bleeding or encephalopathy or ascites refractory to diuretic therapy women who are pregnant or breast feeding
boolean
C0023895 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C4050412 (UMLS CUI [1,3])
C0017181 (UMLS CUI [2])
C0085584 (UMLS CUI [3])
C0003962 (UMLS CUI [4,1])
C0205269 (UMLS CUI [4,2])
C0948575 (UMLS CUI [4,3])
C0032961 (UMLS CUI [5])
C0006147 (UMLS CUI [6])
Contrast media allergy
Item
allergy to contrast media
boolean
C0570562 (UMLS CUI [1])
Medical contraindication Arterial catheterization Hepatic | Peripheral Vascular Disease Severe Excludes Catheterization
Item
contraindication to hepatic artery catheterisation, such as severe peripheral vascular disease precluding catheterisation
boolean
C1301624 (UMLS CUI [1,1])
C0007431 (UMLS CUI [1,2])
C0205054 (UMLS CUI [1,3])
C0085096 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0007430 (UMLS CUI [2,4])
Mental disorder Impact Informed Consent | Other medical condition Impact Informed Consent
Item
psychiatric or other disorder likely to impact on informed consent
boolean
C0004936 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C4049986 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
Treatment Compliance Unable | Treatment Compliance Unwilling
Item
patient unable and/or unwilling to comply with treatment and study instructions
boolean
C4319828 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C4319828 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Lacking Able to swallow Oral Medication
Item
patient unable to swallow oral medications
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
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