ID

4407

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00855218

Link

http://clinicaltrials.gov/show/NCT00855218

Stichworte

Versionen (2)
  1. 09.12.13 09.12.13 - Martin Dugas
  2. 17.09.21 17.09.21 -
Hochgeladen am

9. Dezember 2013

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility NCT00855218 Carcinoma, Hepatocellular

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beschreibung

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter mindestens 18 Jahre
Beschreibung

age at least 18 Years

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Unresectable, multinodular asymptomatic tumor without vascular invasion or extrahepatic spread
Beschreibung

Unresectable, multinodular asymptomatic tumor without vascular invasion or extrahepatic spread

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205416
SNOMED CT 2011_0131
56152004
UMLS CUI 2011AA
C0231221
SNOMED CT 2011_0131
84387000
UMLS CUI 2011AA
C1336869
UMLS CUI 2011AA
C1264755
SNOMED CT 2011_0131
127494000
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C1517058
UMLS CUI 2011AA
C0332261
SNOMED CT 2011_0131
410677005, 410676001
Confirmed Diagnosis of HCC:
Beschreibung

Confirmed Diagnosis of HCC:

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0019204
MedDRA 14.1
10049010
Cirrhotic subjects: Clinical diagnosis by AASLD criteria
Beschreibung

Cirrhotic subjects: Clinical diagnosis by AASLD criteria

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0439686
SNOMED CT 2011_0131
255417007
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0332140
SNOMED CT 2011_0131
39154008
UMLS CUI 2011AA
C0596070
UMLS CUI 2011AA
C0037459
UMLS CUI 2011AA
C0947630
LOINC Version 232
MTHU008392
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
UMLS CUI 2011AA
CL414621
HCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter.
Beschreibung

HCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0019204
MedDRA 14.1
10049010
UMLS CUI 2011AA
C0439686
SNOMED CT 2011_0131
255417007
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0079595
SNOMED CT 2011_0131
278395004
MedDRA 14.1
10068979
UMLS CUI 2011AA
C0040405
MedDRA 14.1
10011603
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
UMLS CUI 2011AA
C0041618
SNOMED CT 2011_0131
16310003
MedDRA 14.1
10065594
LOINC Version 232
MTHU000076
HL7 V3 2006_05
12
UMLS CUI 2011AA
C0493823
SNOMED CT 2011_0131
356442006
Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria.
Beschreibung

Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0085172
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C2919401
SNOMED CT 2011_0131
444734003
Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory
Beschreibung

Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0205471
SNOMED CT 2011_0131
40413002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0023890
SNOMED CT 2011_0131
19943007
MedDRA 14.1
10019641
ICD-10-CM Version 2010
K74.60
Documentation of original biopsy for diagnosis is acceptable
Beschreibung

Documentation of original biopsy for diagnosis is acceptable

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0920316
UMLS CUI 2011AA
C0205313
SNOMED CT 2011_0131
19535007
UMLS CUI 2011AA
C0005558
SNOMED CT 2011_0131
86273004
MedDRA 14.1
10004720
LOINC Version 232
MTHU028106
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1879533
Child Pugh class A without ascites
Beschreibung

Child Pugh class A without ascites

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2347612
UMLS CUI 2011AA
C0456387
SNOMED CT 2011_0131
277046005
UMLS CUI 2011AA
C1706281
SNOMED CT 2011_0131
422097006
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0003962
SNOMED CT 2011_0131
389026000
MedDRA 14.1
10003445
ICD-10-CM Version 2010
R18
ICD-9-CM Version 2011
789.5
CTCAE 1105E
E10502
Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:
Beschreibung

Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0542341
SNOMED CT 2011_0131
246464006
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
C1880016
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
Ausschlusskriterien
Beschreibung

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Patients on a liver transplantation list or with advanced liver disease as defined below:
Beschreibung

Patients on a liver transplantation list or with advanced liver disease as defined below:

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0023911
SNOMED CT 2011_0131
18027006
MedDRA 14.1
10024714
ICD-9-CM Version 2011
50.5
UMLS CUI 2011AA
C0745732
UMLS CUI 2011AA
C0205179
SNOMED CT 2011_0131
86005002
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
Child Pugh B and C
Beschreibung

Child Pugh B and C

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2347612
UMLS CUI 2011AA
C0456387
SNOMED CT 2011_0131
277046005
UMLS CUI 2011AA
C0439105
SNOMED CT 2011_0131
421151005
UMLS CUI 2011AA
C0439106
SNOMED CT 2011_0131
257962003
Active gastrointestinal bleeding
Beschreibung

Active gastrointestinal bleeding

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0017181
SNOMED CT 2011_0131
74474003
MedDRA 14.1
10017955
ICD-10-CM Version 2010
K92.2
ICD-9-CM Version 2011
578
Enzephalopathie
Beschreibung

Encephalopathy

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0085584
SNOMED CT 2011_0131
81308009
MedDRA 14.1
10014625
ICD-10-CM Version 2010
G93.40
ICD-9-CM Version 2011
348.30
CTCAE 1105E
E12652
Aszites
Beschreibung

Ascites

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0003962
SNOMED CT 2011_0131
389026000
MedDRA 14.1
10003445
ICD-10-CM Version 2010
R18
ICD-9-CM Version 2011
789.5
CTCAE 1105E
E10502
Lesions having previously been treated with local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) or cryoablation can not be selected as the target lesions.
Beschreibung

Lesions having previously been treated with local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) or cryoablation can not be selected as the target lesions.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
CL426184
UMLS CUI 2011AA
C0728940
SNOMED CT 2011_0131
65801008
UMLS CUI 2011AA
C0019204
MedDRA 14.1
10049010
UMLS CUI 2011AA
CL382653
UMLS CUI 2011AA
C1880568
UMLS CUI 2011AA
C0010408
SNOMED CT 2011_0131
281609006, 427357007
MedDRA 14.1
10066082
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Unresectable, multinodular asymptomatic tumor without vascular invasion or extrahepatic spread
Item
Unresectable, multinodular asymptomatic tumor without vascular invasion or extrahepatic spread
boolean
C0205416 (UMLS CUI 2011AA)
56152004 (SNOMED CT 2011_0131)
C0231221 (UMLS CUI 2011AA)
84387000 (SNOMED CT 2011_0131)
C1336869 (UMLS CUI 2011AA)
C1264755 (UMLS CUI 2011AA)
127494000 (SNOMED CT 2011_0131)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1517058 (UMLS CUI 2011AA)
C0332261 (UMLS CUI 2011AA)
410677005, 410676001 (SNOMED CT 2011_0131)
Confirmed Diagnosis of HCC:
Item
Confirmed Diagnosis of HCC:
boolean
C0750484 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0019204 (UMLS CUI 2011AA)
10049010 (MedDRA 14.1)
Cirrhotic subjects: Clinical diagnosis by AASLD criteria
Item
Cirrhotic subjects: Clinical diagnosis by AASLD criteria
boolean
C0439686 (UMLS CUI 2011AA)
255417007 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0332140 (UMLS CUI 2011AA)
39154008 (SNOMED CT 2011_0131)
C0596070 (UMLS CUI 2011AA)
C0037459 (UMLS CUI 2011AA)
C0947630 (UMLS CUI 2011AA)
MTHU008392 (LOINC Version 232)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
CL414621 (UMLS CUI 2011AA)
HCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter.
Item
HCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter.
boolean
C0019204 (UMLS CUI 2011AA)
10049010 (MedDRA 14.1)
C0439686 (UMLS CUI 2011AA)
255417007 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1704788 (UMLS CUI 2011AA)
C0079595 (UMLS CUI 2011AA)
278395004 (SNOMED CT 2011_0131)
10068979 (MedDRA 14.1)
C0040405 (UMLS CUI 2011AA)
10011603 (MedDRA 14.1)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C0041618 (UMLS CUI 2011AA)
16310003 (SNOMED CT 2011_0131)
10065594 (MedDRA 14.1)
MTHU000076 (LOINC Version 232)
12 (HL7 V3 2006_05)
C0493823 (UMLS CUI 2011AA)
356442006 (SNOMED CT 2011_0131)
Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria.
Item
Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria.
boolean
C0085172 (UMLS CUI 2011AA)
C0750484 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C0750557 (UMLS CUI 2011AA)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C2919401 (UMLS CUI 2011AA)
444734003 (SNOMED CT 2011_0131)
Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory
Item
Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0205471 (UMLS CUI 2011AA)
40413002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C0750557 (UMLS CUI 2011AA)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0023890 (UMLS CUI 2011AA)
19943007 (SNOMED CT 2011_0131)
10019641 (MedDRA 14.1)
K74.60 (ICD-10-CM Version 2010)
Documentation of original biopsy for diagnosis is acceptable
Item
Documentation of original biopsy for diagnosis is acceptable
boolean
C0920316 (UMLS CUI 2011AA)
C0205313 (UMLS CUI 2011AA)
19535007 (SNOMED CT 2011_0131)
C0005558 (UMLS CUI 2011AA)
86273004 (SNOMED CT 2011_0131)
10004720 (MedDRA 14.1)
MTHU028106 (LOINC Version 232)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1879533 (UMLS CUI 2011AA)
Child Pugh class A without ascites
Item
Child Pugh class A without ascites
boolean
C2347612 (UMLS CUI 2011AA)
C0456387 (UMLS CUI 2011AA)
277046005 (SNOMED CT 2011_0131)
C1706281 (UMLS CUI 2011AA)
422097006 (SNOMED CT 2011_0131)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0003962 (UMLS CUI 2011AA)
389026000 (SNOMED CT 2011_0131)
10003445 (MedDRA 14.1)
R18 (ICD-10-CM Version 2010)
789.5 (ICD-9-CM Version 2011)
E10502 (CTCAE 1105E)
Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:
Item
Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0542341 (UMLS CUI 2011AA)
246464006 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C1516048 (UMLS CUI 2011AA)
C1880016 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Patients on a liver transplantation list or with advanced liver disease as defined below:
Item
Patients on a liver transplantation list or with advanced liver disease as defined below:
boolean
C0023911 (UMLS CUI 2011AA)
18027006 (SNOMED CT 2011_0131)
10024714 (MedDRA 14.1)
50.5 (ICD-9-CM Version 2011)
C0745732 (UMLS CUI 2011AA)
C0205179 (UMLS CUI 2011AA)
86005002 (SNOMED CT 2011_0131)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
Child Pugh B and C
Item
Child Pugh B and C
boolean
C2347612 (UMLS CUI 2011AA)
C0456387 (UMLS CUI 2011AA)
277046005 (SNOMED CT 2011_0131)
C0439105 (UMLS CUI 2011AA)
421151005 (SNOMED CT 2011_0131)
C0439106 (UMLS CUI 2011AA)
257962003 (SNOMED CT 2011_0131)
Active gastrointestinal bleeding
Item
Active gastrointestinal bleeding
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0017181 (UMLS CUI 2011AA)
74474003 (SNOMED CT 2011_0131)
10017955 (MedDRA 14.1)
K92.2 (ICD-10-CM Version 2010)
578 (ICD-9-CM Version 2011)
Encephalopathy
Item
Enzephalopathie
boolean
C0085584 (UMLS CUI 2011AA)
81308009 (SNOMED CT 2011_0131)
10014625 (MedDRA 14.1)
G93.40 (ICD-10-CM Version 2010)
348.30 (ICD-9-CM Version 2011)
E12652 (CTCAE 1105E)
Ascites
Item
Aszites
boolean
C0003962 (UMLS CUI 2011AA)
389026000 (SNOMED CT 2011_0131)
10003445 (MedDRA 14.1)
R18 (ICD-10-CM Version 2010)
789.5 (ICD-9-CM Version 2011)
E10502 (CTCAE 1105E)
Lesions having previously been treated with local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) or cryoablation can not be selected as the target lesions.
Item
Lesions having previously been treated with local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) or cryoablation can not be selected as the target lesions.
boolean
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI 2011AA)
CL426184 (UMLS CUI 2011AA)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C0019204 (UMLS CUI 2011AA)
10049010 (MedDRA 14.1)
CL382653 (UMLS CUI 2011AA)
C1880568 (UMLS CUI 2011AA)
C0010408 (UMLS CUI 2011AA)
281609006, 427357007 (SNOMED CT 2011_0131)
10066082 (MedDRA 14.1)
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