ID

44511

Description

Magnetic Resonance With Gadoxetic Acid for the Diagnosis of Hepatocellular Carcinoma in Patients With Liver Cirrhosis. Evaluation of Its Impact for the Non-invasive Diagnosis; ODM derived from: https://clinicaltrials.gov/show/NCT01575574

Link

https://clinicaltrials.gov/show/NCT01575574

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 NCT01575574

English

Eligibility Hepatocellular Carcinoma NCT01575574

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
more than 18 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient with diagnosis of liver cirrhosis child pugh a-b
Description

Liver Cirrhosis Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C4050412
patients without previous hepatocellular carcinoma in whom ultrasound detects a suspicious hepatic lesion; solitary solid and well-defined nodule between 10 and 20mm
Description

Absence Liver carcinoma Previous | Lesion of liver Suspicious Ultrasonography | Nodule Solid Solitary | Nodule size

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C2239176
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C0577053
UMLS CUI [2,2]
C0750493
UMLS CUI [2,3]
C0041618
UMLS CUI [3,1]
C0028259
UMLS CUI [3,2]
C0205208
UMLS CUI [3,3]
C0205171
UMLS CUI [4]
C0449457
patients in whom diagnosis of hepatocellular carcinoma is a clinical need prior to treatment indication
Description

Liver carcinoma | Status pre- Treatment Indication

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C3146298
patient that agree to participate signing informed consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with poor liver function who would have undergone transplantation even without hepatocellular carcinoma diagnosis (child-pugh c)
Description

Liver Dysfunction Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C4050412
patients with previous diagnosis of hepatocellular carcinoma
Description

Prior diagnosis Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0332132
UMLS CUI [1,2]
C2239176
patients with significant comorbidities that could prevent the optimum therapeutic decision in case of positive diagnosis of hepatocellular carcinoma
Description

Comorbidity Preventing Therapy Optimal

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C2698651
patients with severe clotting alterations that contraindicate the fine-needle biopsy-patients with chronic kidney disease or glomerular filtration rate < 30 ml/min
Description

Alteration in clotting Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C4062962
UMLS CUI [1,2]
C0205082
patients with contraindications to perform magnetic resonance imaging (pacemaker, claustrophobia...)
Description

Medical contraindication Magnetic Resonance Imaging | Pacemakers | Claustrophobia

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0810633
UMLS CUI [3]
C0008909
known hypersensitivity to study drugs or excipients
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipients

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0015237
pregnancy or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Hepatocellular Carcinoma NCT01575574

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
more than 18 years old
boolean
C0001779 (UMLS CUI [1])
Liver Cirrhosis Child-Pugh Classification
Item
patient with diagnosis of liver cirrhosis child pugh a-b
boolean
C0023890 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Absence Liver carcinoma Previous | Lesion of liver Suspicious Ultrasonography | Nodule Solid Solitary | Nodule size
Item
patients without previous hepatocellular carcinoma in whom ultrasound detects a suspicious hepatic lesion; solitary solid and well-defined nodule between 10 and 20mm
boolean
C0332197 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0577053 (UMLS CUI [2,1])
C0750493 (UMLS CUI [2,2])
C0041618 (UMLS CUI [2,3])
C0028259 (UMLS CUI [3,1])
C0205208 (UMLS CUI [3,2])
C0205171 (UMLS CUI [3,3])
C0449457 (UMLS CUI [4])
Liver carcinoma | Status pre- Treatment Indication
Item
patients in whom diagnosis of hepatocellular carcinoma is a clinical need prior to treatment indication
boolean
C2239176 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C3146298 (UMLS CUI [2,3])
Informed Consent
Item
patient that agree to participate signing informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Liver Dysfunction Child-Pugh Classification
Item
patients with poor liver function who would have undergone transplantation even without hepatocellular carcinoma diagnosis (child-pugh c)
boolean
C0086565 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Prior diagnosis Liver carcinoma
Item
patients with previous diagnosis of hepatocellular carcinoma
boolean
C0332132 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
Comorbidity Preventing Therapy Optimal
Item
patients with significant comorbidities that could prevent the optimum therapeutic decision in case of positive diagnosis of hepatocellular carcinoma
boolean
C0009488 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C2698651 (UMLS CUI [1,4])
Alteration in clotting Severe
Item
patients with severe clotting alterations that contraindicate the fine-needle biopsy-patients with chronic kidney disease or glomerular filtration rate < 30 ml/min
boolean
C4062962 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Medical contraindication Magnetic Resonance Imaging | Pacemakers | Claustrophobia
Item
patients with contraindications to perform magnetic resonance imaging (pacemaker, claustrophobia...)
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0810633 (UMLS CUI [2])
C0008909 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipients
Item
known hypersensitivity to study drugs or excipients
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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