ID

38380

Description

Expansion of Conventional Criteria for Liver Transplantation in Hepatocellular Carcinoma Through Downstaging; ODM derived from: https://clinicaltrials.gov/show/NCT01387503

Link

https://clinicaltrials.gov/show/NCT01387503

Keywords

Versions (2)
  1. 10/14/19 10/14/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 14, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Hepatocellular NCT01387503

English

Eligibility Carcinoma, Hepatocellular NCT01387503

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient's age ≥ 18 yrs and ≤ 65 yrs
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
presence of cirrhosis of any etiology
Description

Liver Cirrhosis | Etiology Any

Data type

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C1552551
child-pugh class ≤ b7
Description

Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1]
C2347612
ecog performance status ≤ 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
diagnosis of hcc either by biopsy or according to aasld criteria
Description

Liver carcinoma Biopsy | Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0005558
UMLS CUI [2]
C2239176
hcc exceeding milan criteria with a 5-yr estimated survival after transplantation >50% according to the metroticket calculator (http://www.hcc-olt-metroticket.org/calculator)
Description

Liver carcinoma | Survival time Estimated | Status post Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C2919552
UMLS CUI [2,2]
C0750572
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0040732
women of child bearing potential with a negative serum pregnancy test performed before enrolment
Description

Childbearing Potential Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
absence of general contraindications to sorafenib/molecular targeted therapies
Description

Medical contraindication Absent Sorafenib Targeted Therapy | Medical contraindication Absent Molecular Targeted Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1516119
UMLS CUI [1,4]
C2985566
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C2699893
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of extra-hepatic tumor spread
Description

Neoplasm Spread Extrahepatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0332261
UMLS CUI [1,3]
C1517058
presence of macrovascular invasion
Description

Invasion Macrovascular

Data type

boolean

Alias
UMLS CUI [1,1]
C1269955
UMLS CUI [1,2]
C2609253
sorafenib therapy started > 2 months before enrolment
Description

Sorafenib Started

Data type

boolean

Alias
UMLS CUI [1,1]
C1516119
UMLS CUI [1,2]
C1272689
concurrent cancer, distinct from hcc (except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors)
Description

Cancer Other | Exception Liver carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Superficial carcinoma of urinary bladder

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2239176
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1336527
previous history of any cancer, even if curatively treated, < 5 years prior to entry
Description

History of cancer | Curative treatment Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0455471
UMLS CUI [2,1]
C1273390
UMLS CUI [2,2]
C0006826
active intra-venous or alcohol abusers
Description

Substance Abuse, Intravenous | Alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038579
UMLS CUI [2]
C0085762
hiv infection
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
history of serious cardiac disease
Description

Heart Disease Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
severe pulmonary hypertension not treatable by medical therapy
Description

Pulmonary hypertension, severe | Therapy Unsuccessful

Data type

boolean

Alias
UMLS CUI [1]
C2750273
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1272705
patients with a life expectancy of less than 3 months due to hcc or less than 6 months due to any other disease
Description

Life Expectancy | Etiology Liver carcinoma | Etiology Disease Other

Data type

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C2239176
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0205394
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Similar models

Eligibility Carcinoma, Hepatocellular NCT01387503

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient's age ≥ 18 yrs and ≤ 65 yrs
boolean
C0001779 (UMLS CUI [1])
Liver Cirrhosis | Etiology Any
Item
presence of cirrhosis of any etiology
boolean
C0023890 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
Child-Pugh Classification
Item
child-pugh class ≤ b7
boolean
C2347612 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status ≤ 1
boolean
C1520224 (UMLS CUI [1])
Liver carcinoma Biopsy | Liver carcinoma
Item
diagnosis of hcc either by biopsy or according to aasld criteria
boolean
C2239176 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2])
Liver carcinoma | Survival time Estimated | Status post Transplantation
Item
hcc exceeding milan criteria with a 5-yr estimated survival after transplantation >50% according to the metroticket calculator (http://www.hcc-olt-metroticket.org/calculator)
boolean
C2239176 (UMLS CUI [1])
C2919552 (UMLS CUI [2,1])
C0750572 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0040732 (UMLS CUI [3,2])
Childbearing Potential Serum pregnancy test negative
Item
women of child bearing potential with a negative serum pregnancy test performed before enrolment
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Medical contraindication Absent Sorafenib Targeted Therapy | Medical contraindication Absent Molecular Targeted Therapy
Item
absence of general contraindications to sorafenib/molecular targeted therapies
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1516119 (UMLS CUI [1,3])
C2985566 (UMLS CUI [1,4])
C1301624 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C2699893 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Neoplasm Spread Extrahepatic
Item
presence of extra-hepatic tumor spread
boolean
C0027651 (UMLS CUI [1,1])
C0332261 (UMLS CUI [1,2])
C1517058 (UMLS CUI [1,3])
Invasion Macrovascular
Item
presence of macrovascular invasion
boolean
C1269955 (UMLS CUI [1,1])
C2609253 (UMLS CUI [1,2])
Sorafenib Started
Item
sorafenib therapy started > 2 months before enrolment
boolean
C1516119 (UMLS CUI [1,1])
C1272689 (UMLS CUI [1,2])
Cancer Other | Exception Liver carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Superficial carcinoma of urinary bladder
Item
concurrent cancer, distinct from hcc (except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1336527 (UMLS CUI [5,2])
History of cancer | Curative treatment Malignant Neoplasms
Item
previous history of any cancer, even if curatively treated, < 5 years prior to entry
boolean
C0455471 (UMLS CUI [1])
C1273390 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
Substance Abuse, Intravenous | Alcohol abuse
Item
active intra-venous or alcohol abusers
boolean
C0038579 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
HIV Infection
Item
hiv infection
boolean
C0019693 (UMLS CUI [1])
Heart Disease Serious
Item
history of serious cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Pulmonary hypertension, severe | Therapy Unsuccessful
Item
severe pulmonary hypertension not treatable by medical therapy
boolean
C2750273 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Life Expectancy | Etiology Liver carcinoma | Etiology Disease Other
Item
patients with a life expectancy of less than 3 months due to hcc or less than 6 months due to any other disease
boolean
C0023671 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0205394 (UMLS CUI [3,3])
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