ID

44508

Description

RCT on Adjuvant TACE After Hepatectomy for HCC; ODM derived from: https://clinicaltrials.gov/show/NCT01512407

Link

https://clinicaltrials.gov/show/NCT01512407

Keywords

Versions (2)
  1. 2/19/20 2/19/20 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01512407

English

Eligibility Hepatocellular Carcinoma NCT01512407

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
hcc patients received curative hepatectomy with negative resection margin
Description

Liver carcinoma | Hepatectomy Curative | Negative Surgical Margin

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0019144
UMLS CUI [2,2]
C1276305
UMLS CUI [3]
C1709157
age from 18 to 70
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
child-pugh class a
Description

Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1]
C4050412
asa class i to iii
Description

ASA physical status class

Data type

boolean

Alias
UMLS CUI [1]
C0578808
ecog performance status grade 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients receiving concomitant local ablation or previous tace
Description

Local ablation therapy | Transarterial Chemoembolization Previous

Data type

boolean

Alias
UMLS CUI [1]
C0547070
UMLS CUI [2,1]
C3539919
UMLS CUI [2,2]
C0205156
main portal vein tumour thrombus extraction during hepatectomy
Description

Main portal vein Tumor thrombus Extraction | Hepatectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C1183135
UMLS CUI [1,2]
C3163918
UMLS CUI [1,3]
C0185115
UMLS CUI [2]
C0019144
tumour arising from caudate lobe
Description

Tumor Origin Caudate lobe

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0227489
presence of extra-hepatic disease
Description

Disease Extrahepatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517058
very early hcc with solitary tumour and size < 2cm
Description

Very Early Hepatocellular Carcinoma | Single tumor | Tumor size

Data type

boolean

Alias
UMLS CUI [1,1]
C3273019
UMLS CUI [1,2]
C0442824
UMLS CUI [2]
C1298180
UMLS CUI [3]
C0475440
impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin < 25g/l or bilirubin > 50micromol/l
Description

Liver Dysfunction | Ascites | Hepatic Encephalopathy | Serum albumin measurement | Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0019151
UMLS CUI [4]
C0523465
UMLS CUI [5]
C1278039
renal impairment with creatinine > 200micromol/l
Description

Renal Insufficiency | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
severe concurrent medical illness persisting > 6 weeks after hepatectomy
Description

Comorbidity Severe Persistent | Status post Hepatectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205322
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0019144
history of other cancer
Description

Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1707251
hepatic artery anomaly making tace not possible
Description

Hepatic artery Abnormality | Transarterial Chemoembolization Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0019145
UMLS CUI [1,2]
C1704258
UMLS CUI [2,1]
C3539919
UMLS CUI [2,2]
C1272705
allergy to cisplatin or lipiodol
Description

Cisplatin allergy | Hypersensitivity Lipiodol

Data type

boolean

Alias
UMLS CUI [1]
C0570702
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0947677
pregnant woman
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
informed consent not available
Description

Informed Consent Unavailable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0686905
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Similar models

Eligibility Hepatocellular Carcinoma NCT01512407

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma | Hepatectomy Curative | Negative Surgical Margin
Item
hcc patients received curative hepatectomy with negative resection margin
boolean
C2239176 (UMLS CUI [1])
C0019144 (UMLS CUI [2,1])
C1276305 (UMLS CUI [2,2])
C1709157 (UMLS CUI [3])
Age
Item
age from 18 to 70
boolean
C0001779 (UMLS CUI [1])
Child-Pugh Classification
Item
child-pugh class a
boolean
C4050412 (UMLS CUI [1])
ASA physical status class
Item
asa class i to iii
boolean
C0578808 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status grade 0 or 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Local ablation therapy | Transarterial Chemoembolization Previous
Item
patients receiving concomitant local ablation or previous tace
boolean
C0547070 (UMLS CUI [1])
C3539919 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Main portal vein Tumor thrombus Extraction | Hepatectomy
Item
main portal vein tumour thrombus extraction during hepatectomy
boolean
C1183135 (UMLS CUI [1,1])
C3163918 (UMLS CUI [1,2])
C0185115 (UMLS CUI [1,3])
C0019144 (UMLS CUI [2])
Tumor Origin Caudate lobe
Item
tumour arising from caudate lobe
boolean
C0027651 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0227489 (UMLS CUI [1,3])
Disease Extrahepatic
Item
presence of extra-hepatic disease
boolean
C0012634 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
Very Early Hepatocellular Carcinoma | Single tumor | Tumor size
Item
very early hcc with solitary tumour and size < 2cm
boolean
C3273019 (UMLS CUI [1,1])
C0442824 (UMLS CUI [1,2])
C1298180 (UMLS CUI [2])
C0475440 (UMLS CUI [3])
Liver Dysfunction | Ascites | Hepatic Encephalopathy | Serum albumin measurement | Serum total bilirubin measurement
Item
impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin < 25g/l or bilirubin > 50micromol/l
boolean
C0086565 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
C0523465 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
Renal Insufficiency | Creatinine measurement, serum
Item
renal impairment with creatinine > 200micromol/l
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Comorbidity Severe Persistent | Status post Hepatectomy
Item
severe concurrent medical illness persisting > 6 weeks after hepatectomy
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0019144 (UMLS CUI [2,2])
Cancer Other
Item
history of other cancer
boolean
C1707251 (UMLS CUI [1])
Hepatic artery Abnormality | Transarterial Chemoembolization Unsuccessful
Item
hepatic artery anomaly making tace not possible
boolean
C0019145 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C3539919 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Cisplatin allergy | Hypersensitivity Lipiodol
Item
allergy to cisplatin or lipiodol
boolean
C0570702 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0947677 (UMLS CUI [2,2])
Pregnancy
Item
pregnant woman
boolean
C0032961 (UMLS CUI [1])
Informed Consent Unavailable
Item
informed consent not available
boolean
C0021430 (UMLS CUI [1,1])
C0686905 (UMLS CUI [1,2])
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