ID

29802

Description

Cytoreductive Surgery and Transarterial Chemoembolization (TACE) Versus TACE for Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00820157

Link

https://clinicaltrials.gov/show/NCT00820157

Keywords

Versions (2)
  1. 4/20/18 4/20/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 20, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00820157

English

Eligibility Hepatocellular Carcinoma NCT00820157

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients > 18 years and <=70 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
at least 2 radiologic imaging showing characteristic features of hcc or one radiologic imaging associated with afp ＞400 or cytologic/histologic evidence.
Description

Liver carcinoma Characteristics Radiographic imaging Quantity | Radiographic imaging Associated with Alpha one fetoprotein measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1521970
UMLS CUI [1,3]
C1962945
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C1962945
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0201539
tumor number >3 and <=5,maximum diameter >5cm and <=15cm;without evidence of radiologically definable vascular invasion or extrahepatic metastasis.
Description

Neoplasms Number | Neoplasm Diameter Maximum | Absence Invasion Vascular Radiology | Absence Neoplasm Metastasis Extrahepatic Radiology

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0237753
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0806909
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C1269955
UMLS CUI [3,3]
C1801960
UMLS CUI [3,4]
C1962945
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0027627
UMLS CUI [4,3]
C1517058
UMLS CUI [4,4]
C1962945
criteria of liver function: child a-b level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
Description

Liver function | Child-Pugh Classification | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C2347612
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201899
no dysfunction in major organs; blood routine, kidney function, cardiac function and lung function are basically normal.
Description

Absence Dysfunction Organ Major | Hematologic function | Renal function | Cardiac function | Pulmonary function

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C3887504
UMLS CUI [1,3]
C0178784
UMLS CUI [1,4]
C0205164
UMLS CUI [2]
C0221130
UMLS CUI [3]
C0232804
UMLS CUI [4]
C0232164
UMLS CUI [5]
C0231921
hb ≥90g/l,wbc ≥3.000 cells/mm³,platelets ≥80.000 cells/mm³
Description

Hemoglobin measurement | White Blood Cell Count procedure | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0032181
patients who can understand this trial and have signed information consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
Description

Cardiac dysfunction Affecting Therapy Liver cancer | Pulmonary Dysfunction Affecting Therapy Liver cancer | Brain dysfunction Affecting Therapy Liver cancer | Renal dysfunction Affecting Therapy Liver cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C3277906
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0345904
UMLS CUI [2,1]
C1709770
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C0345904
UMLS CUI [3,1]
C0262405
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0087111
UMLS CUI [3,4]
C0345904
UMLS CUI [4,1]
C3279454
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0087111
UMLS CUI [4,4]
C0345904
patients with other diseases which may affect the treatment mentioned.
Description

Disease Affecting Clinical Trial Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0087111
patients with a medical history of other malignant tumors.
Description

Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1707251
subjects participating in other clinical trials.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
extrahepatic metastasis, portal vein or other major vascular involvement.
Description

Neoplasm Metastasis Extrahepatic | Portal vein Involvement | Involvement Vascular Major

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517058
UMLS CUI [2,1]
C1305775
UMLS CUI [2,2]
C1314939
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C1801960
UMLS CUI [3,3]
C0205164
liver function:child c.
Description

Liver function Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C2347612
no pathological evidence of hcc.
Description

Liver carcinoma Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0332197
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Similar models

Eligibility Hepatocellular Carcinoma NCT00820157

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients > 18 years and <=70 years of age.
boolean
C0001779 (UMLS CUI [1])
Liver carcinoma Characteristics Radiographic imaging Quantity | Radiographic imaging Associated with Alpha one fetoprotein measurement
Item
at least 2 radiologic imaging showing characteristic features of hcc or one radiologic imaging associated with afp ＞400 or cytologic/histologic evidence.
boolean
C2239176 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
C1962945 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C1962945 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0201539 (UMLS CUI [2,3])
Neoplasms Number | Neoplasm Diameter Maximum | Absence Invasion Vascular Radiology | Absence Neoplasm Metastasis Extrahepatic Radiology
Item
tumor number >3 and <=5,maximum diameter >5cm and <=15cm;without evidence of radiologically definable vascular invasion or extrahepatic metastasis.
boolean
C0027651 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C1269955 (UMLS CUI [3,2])
C1801960 (UMLS CUI [3,3])
C1962945 (UMLS CUI [3,4])
C0332197 (UMLS CUI [4,1])
C0027627 (UMLS CUI [4,2])
C1517058 (UMLS CUI [4,3])
C1962945 (UMLS CUI [4,4])
Liver function | Child-Pugh Classification | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
criteria of liver function: child a-b level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
boolean
C0232741 (UMLS CUI [1])
C2347612 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
Absence Dysfunction Organ Major | Hematologic function | Renal function | Cardiac function | Pulmonary function
Item
no dysfunction in major organs; blood routine, kidney function, cardiac function and lung function are basically normal.
boolean
C0332197 (UMLS CUI [1,1])
C3887504 (UMLS CUI [1,2])
C0178784 (UMLS CUI [1,3])
C0205164 (UMLS CUI [1,4])
C0221130 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0232164 (UMLS CUI [4])
C0231921 (UMLS CUI [5])
Hemoglobin measurement | White Blood Cell Count procedure | Platelet Count measurement
Item
hb ≥90g/l,wbc ≥3.000 cells/mm³,platelets ≥80.000 cells/mm³
boolean
C0518015 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Informed Consent
Item
patients who can understand this trial and have signed information consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cardiac dysfunction Affecting Therapy Liver cancer | Pulmonary Dysfunction Affecting Therapy Liver cancer | Brain dysfunction Affecting Therapy Liver cancer | Renal dysfunction Affecting Therapy Liver cancer
Item
patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
boolean
C3277906 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0345904 (UMLS CUI [1,4])
C1709770 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0345904 (UMLS CUI [2,4])
C0262405 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0345904 (UMLS CUI [3,4])
C3279454 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C0345904 (UMLS CUI [4,4])
Disease Affecting Clinical Trial Therapy
Item
patients with other diseases which may affect the treatment mentioned.
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Cancer Other
Item
patients with a medical history of other malignant tumors.
boolean
C1707251 (UMLS CUI [1])
Study Subject Participation Status
Item
subjects participating in other clinical trials.
boolean
C2348568 (UMLS CUI [1])
Neoplasm Metastasis Extrahepatic | Portal vein Involvement | Involvement Vascular Major
Item
extrahepatic metastasis, portal vein or other major vascular involvement.
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C1305775 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C1314939 (UMLS CUI [3,1])
C1801960 (UMLS CUI [3,2])
C0205164 (UMLS CUI [3,3])
Liver function Child-Pugh Classification
Item
liver function:child c.
boolean
C0232741 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
Liver carcinoma Absent
Item
no pathological evidence of hcc.
boolean
C2239176 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
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