ID

44626

Descrição

Y90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver; ODM derived from: https://clinicaltrials.gov/show/NCT01686880

Link

https://clinicaltrials.gov/show/NCT01686880

Palavras-chave

Versões (2)
  1. 05/06/2020 05/06/2020 -
  2. 27/09/2021 27/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

27 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01686880

Inglês

Eligibility Hepatocellular Carcinoma NCT01686880

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥18 years.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
cirrhotic liver demonstrated by typical liver dysmorphy on imaging and/or liver biopsy.
Descrição

Liver Cirrhosis Imaging | Liver Cirrhosis Biopsy of liver

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0011923
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0193388
hcc with at least one lesion measuring more than 1 cm in diameter with a single dynamic imaging technique (ct or mri), showing intense arterial uptake followed by washout of contrast in the venous-delayed phases, or diagnosed by biopsy.
Descrição

Liver carcinoma | Lesion Diameter Computed Tomography | Lesion Diameter MRI | Lesion Quantity | Liver carcinoma Biopsy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0040405
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1301886
UMLS CUI [3,3]
C0024485
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C1265611
UMLS CUI [5,1]
C2239176
UMLS CUI [5,2]
C0005558
borderline resectable disease eligible for surgical resection or radiofrequency destruction.
Descrição

Borderline Lesion Resectable | Borderline Lesion Eligible Excision | Borderline Lesion Eligible Radiofrequency destruction

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1332594
UMLS CUI [1,2]
C1514888
UMLS CUI [2,1]
C1332594
UMLS CUI [2,2]
C1548635
UMLS CUI [2,3]
C0728940
UMLS CUI [3,1]
C1332594
UMLS CUI [3,2]
C1548635
UMLS CUI [3,3]
C0441517
no extra-hepatic dissemination.
Descrição

Absence Dissemination Extrahepatic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0205221
UMLS CUI [1,3]
C1517058
ecog performance status < 2.
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Descrição

Childbearing Potential Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C2985296
UMLS CUI [3]
C0004764
UMLS CUI [4]
C0036899
signed written informed consent (approved by an independent ethics committee) obtained prior to any study specific baseline procedures.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
decompensated cirrhosis (child pugh b, c).
Descrição

Decompensated cirrhosis of liver Child-Pugh Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1619727
UMLS CUI [1,2]
C4050412
extra-hepatic tumour spread.
Descrição

Tumor Spread Extrahepatic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0332261
UMLS CUI [1,3]
C1517058
previous or concomitant malignancies within five years other than basal cell carcinoma of the skin.
Descrição

Cancer Other | Exception Basal cell carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
pregnancy, lactation or refusal to use adequate contraceptive measures (hormonal or barrier method of birth control, abstinence).
Descrição

Pregnancy | Breast Feeding | Contraceptive methods Refused | Hormonal contraception Refused | Barrier Contraception Refused | Sexual Abstinence Refused

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C1705116
UMLS CUI [4,1]
C2985296
UMLS CUI [4,2]
C1705116
UMLS CUI [5,1]
C0004764
UMLS CUI [5,2]
C1705116
UMLS CUI [6,1]
C0036899
UMLS CUI [6,2]
C1705116
pre-existing other hepatic disease (liver abscess, hepatic sarcoidosis or tuberculosis, sclerosing cholangitis, …).
Descrição

Liver disease Pre-existing | Liver Abscess | Liver sarcoidosis | Tuberculosis, Hepatic | Cholangitis, Sclerosing

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C2347662
UMLS CUI [2]
C0023885
UMLS CUI [3]
C0744822
UMLS CUI [4]
C0041313
UMLS CUI [5]
C0008313
previous trans-arterial radioembolization (tare).
Descrição

Transarterial Radioembolization

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3889650
history of allergic reactions attributed to compounds of similar chemical or biologic composition of the administered materials.
Descrição

Allergic Reaction Compound Investigational New Drugs Similar

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C0013230
UMLS CUI [1,4]
C2348205
bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months.
Descrição

Bleeding tendency | Ischemia Cardiovascular | Cerebrovascular accident

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2,1]
C0022116
UMLS CUI [2,2]
C3887460
UMLS CUI [3]
C0038454
major surgery within four weeks.
Descrição

Major surgery

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0679637
uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Descrição

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
uncontrolled diabetes.
Descrição

Diabetic - poor control

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0421258
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Similar models

Eligibility Hepatocellular Carcinoma NCT01686880

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥18 years.
boolean
C0001779 (UMLS CUI [1])
Liver Cirrhosis Imaging | Liver Cirrhosis Biopsy of liver
Item
cirrhotic liver demonstrated by typical liver dysmorphy on imaging and/or liver biopsy.
boolean
C0023890 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C0193388 (UMLS CUI [2,2])
Liver carcinoma | Lesion Diameter Computed Tomography | Lesion Diameter MRI | Lesion Quantity | Liver carcinoma Biopsy
Item
hcc with at least one lesion measuring more than 1 cm in diameter with a single dynamic imaging technique (ct or mri), showing intense arterial uptake followed by washout of contrast in the venous-delayed phases, or diagnosed by biopsy.
boolean
C2239176 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C0221198 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
C0221198 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C2239176 (UMLS CUI [5,1])
C0005558 (UMLS CUI [5,2])
Borderline Lesion Resectable | Borderline Lesion Eligible Excision | Borderline Lesion Eligible Radiofrequency destruction
Item
borderline resectable disease eligible for surgical resection or radiofrequency destruction.
boolean
C1332594 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C1332594 (UMLS CUI [2,1])
C1548635 (UMLS CUI [2,2])
C0728940 (UMLS CUI [2,3])
C1332594 (UMLS CUI [3,1])
C1548635 (UMLS CUI [3,2])
C0441517 (UMLS CUI [3,3])
Absence Dissemination Extrahepatic
Item
no extra-hepatic dissemination.
boolean
C0332197 (UMLS CUI [1,1])
C0205221 (UMLS CUI [1,2])
C1517058 (UMLS CUI [1,3])
ECOG performance status
Item
ecog performance status < 2.
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
Item
women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C2985296 (UMLS CUI [2])
C0004764 (UMLS CUI [3])
C0036899 (UMLS CUI [4])
Informed Consent
Item
signed written informed consent (approved by an independent ethics committee) obtained prior to any study specific baseline procedures.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Decompensated cirrhosis of liver Child-Pugh Classification
Item
decompensated cirrhosis (child pugh b, c).
boolean
C1619727 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Tumor Spread Extrahepatic
Item
extra-hepatic tumour spread.
boolean
C0027651 (UMLS CUI [1,1])
C0332261 (UMLS CUI [1,2])
C1517058 (UMLS CUI [1,3])
Cancer Other | Exception Basal cell carcinoma
Item
previous or concomitant malignancies within five years other than basal cell carcinoma of the skin.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Contraceptive methods Refused | Hormonal contraception Refused | Barrier Contraception Refused | Sexual Abstinence Refused
Item
pregnancy, lactation or refusal to use adequate contraceptive measures (hormonal or barrier method of birth control, abstinence).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C1705116 (UMLS CUI [3,2])
C2985296 (UMLS CUI [4,1])
C1705116 (UMLS CUI [4,2])
C0004764 (UMLS CUI [5,1])
C1705116 (UMLS CUI [5,2])
C0036899 (UMLS CUI [6,1])
C1705116 (UMLS CUI [6,2])
Liver disease Pre-existing | Liver Abscess | Liver sarcoidosis | Tuberculosis, Hepatic | Cholangitis, Sclerosing
Item
pre-existing other hepatic disease (liver abscess, hepatic sarcoidosis or tuberculosis, sclerosing cholangitis, …).
boolean
C0023895 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0023885 (UMLS CUI [2])
C0744822 (UMLS CUI [3])
C0041313 (UMLS CUI [4])
C0008313 (UMLS CUI [5])
Transarterial Radioembolization
Item
previous trans-arterial radioembolization (tare).
boolean
C3889650 (UMLS CUI [1])
Allergic Reaction Compound Investigational New Drugs Similar
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition of the administered materials.
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
Bleeding tendency | Ischemia Cardiovascular | Cerebrovascular accident
Item
bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months.
boolean
C1458140 (UMLS CUI [1])
C0022116 (UMLS CUI [2,1])
C3887460 (UMLS CUI [2,2])
C0038454 (UMLS CUI [3])
Major surgery
Item
major surgery within four weeks.
boolean
C0679637 (UMLS CUI [1])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Diabetic - poor control
Item
uncontrolled diabetes.
boolean
C0421258 (UMLS CUI [1])
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