ID

39809

Beschreibung

Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma With Major Portal Vein Invasion; ODM derived from: https://clinicaltrials.gov/show/NCT01850368

Link

https://clinicaltrials.gov/show/NCT01850368

Stichworte

Versionen (2)
  1. 22.02.20 22.02.20 -
  2. 27.09.21 27.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

22. Februar 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01850368

Englisch

Eligibility Hepatocellular Carcinoma NCT01850368

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients ≥ 20 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
initially diagnosed or recurrent hepatocellular carcinoma (hcc)
Beschreibung

Liver carcinoma | Recurrent Hepatocellular Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2]
C0861876
eastern cooperative oncology group performance status 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
hcc with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein)
Beschreibung

Liver carcinoma | Main portal vein Tumour thrombosis

Datentyp

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C1183135
UMLS CUI [2,2]
C2242635
cirrhotic status of child pugh class a or b7
Beschreibung

Status Cirrhotic Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0439686
UMLS CUI [1,3]
C2347612
patients can have extra-hepatic disease; provided the hepatic disease is the highest burden, the extra-hepatic disease is low burden and potentially treatable with radiotherapy, chemotherapy and target agent etc; patient survival is expected to be at least 6 months.
Beschreibung

Disease Extrahepatic | Liver disease Burden Highest | Disease Extrahepatic Burden low | Therapeutic radiology procedure Disease Extrahepatic | Chemotherapy Disease Extrahepatic | Targeted Therapy Disease Extrahepatic | Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517058
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C1449699
UMLS CUI [2,3]
C1522410
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1517058
UMLS CUI [3,3]
C1449699
UMLS CUI [3,4]
C0205251
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C1517058
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C1517058
UMLS CUI [6,1]
C2985566
UMLS CUI [6,2]
C0012634
UMLS CUI [6,3]
C1517058
UMLS CUI [7]
C0023671
patient or guardian must be able to provide verbal and written informed consent
Beschreibung

Informed Consent | Informed Consent Guardian

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior trans-arterial chemo-embolization ≥4 after diagnosis of major portal vein tumor thrombosis
Beschreibung

Transarterial Chemoembolization Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3539919
UMLS CUI [1,2]
C1265611
severe complication caused by liver cirrhosis eg. variceal bleeding, poorly controlled ascites, hepatic encephalopathy)
Beschreibung

Severe complication caused by Liver Cirrhosis | Bleeding varices | Ascites Poorly controlled | Hepatic Encephalopathy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3495031
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0023890
UMLS CUI [2]
C0333106
UMLS CUI [3,1]
C0003962
UMLS CUI [3,2]
C3853134
UMLS CUI [4]
C0019151
uncontrolled inter-current illness except liver cirrhosis
Beschreibung

Comorbidity Uncontrolled | Exception Liver Cirrhosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0023890
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Ähnliche Modelle

Eligibility Hepatocellular Carcinoma NCT01850368

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients ≥ 20 years of age
boolean
C0001779 (UMLS CUI [1])
Liver carcinoma | Recurrent Hepatocellular Carcinoma
Item
initially diagnosed or recurrent hepatocellular carcinoma (hcc)
boolean
C2239176 (UMLS CUI [1])
C0861876 (UMLS CUI [2])
ECOG performance status
Item
eastern cooperative oncology group performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Liver carcinoma | Main portal vein Tumour thrombosis
Item
hcc with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein)
boolean
C2239176 (UMLS CUI [1])
C1183135 (UMLS CUI [2,1])
C2242635 (UMLS CUI [2,2])
Status Cirrhotic Child-Pugh Classification
Item
cirrhotic status of child pugh class a or b7
boolean
C0449438 (UMLS CUI [1,1])
C0439686 (UMLS CUI [1,2])
C2347612 (UMLS CUI [1,3])
Disease Extrahepatic | Liver disease Burden Highest | Disease Extrahepatic Burden low | Therapeutic radiology procedure Disease Extrahepatic | Chemotherapy Disease Extrahepatic | Targeted Therapy Disease Extrahepatic | Life Expectancy
Item
patients can have extra-hepatic disease; provided the hepatic disease is the highest burden, the extra-hepatic disease is low burden and potentially treatable with radiotherapy, chemotherapy and target agent etc; patient survival is expected to be at least 6 months.
boolean
C0012634 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C1449699 (UMLS CUI [2,2])
C1522410 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C1517058 (UMLS CUI [3,2])
C1449699 (UMLS CUI [3,3])
C0205251 (UMLS CUI [3,4])
C1522449 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C1517058 (UMLS CUI [4,3])
C0392920 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C1517058 (UMLS CUI [5,3])
C2985566 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
C1517058 (UMLS CUI [6,3])
C0023671 (UMLS CUI [7])
Informed Consent | Informed Consent Guardian
Item
patient or guardian must be able to provide verbal and written informed consent
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Transarterial Chemoembolization Quantity
Item
prior trans-arterial chemo-embolization ≥4 after diagnosis of major portal vein tumor thrombosis
boolean
C3539919 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Severe complication caused by Liver Cirrhosis | Bleeding varices | Ascites Poorly controlled | Hepatic Encephalopathy
Item
severe complication caused by liver cirrhosis eg. variceal bleeding, poorly controlled ascites, hepatic encephalopathy)
boolean
C3495031 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0023890 (UMLS CUI [1,3])
C0333106 (UMLS CUI [2])
C0003962 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
C0019151 (UMLS CUI [4])
Comorbidity Uncontrolled | Exception Liver Cirrhosis
Item
uncontrolled inter-current illness except liver cirrhosis
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0023890 (UMLS CUI [2,2])
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