ID

39813

Descrição

Combine TACE and RFA Versus RFA Monotherapy in Unilobar HCC of 3.1 to 7 cm Patient; ODM derived from: https://clinicaltrials.gov/show/NCT01858207

Link

https://clinicaltrials.gov/show/NCT01858207

Palavras-chave

Versões (2)
  1. 22/02/2020 22/02/2020 -
  2. 27/09/2021 27/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

22 de fevereiro de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01858207

Inglês

Eligibility Hepatocellular Carcinoma NCT01858207

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
unresectable hcc or patients with resectable hcc but not appropriate for resection;.
Descrição

Liver carcinoma unresectable | Liver carcinoma Resectable | Patients Inappropriate Excision

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1519810
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C1514888
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C0728940
tumor stage: single tumor with 3.1-7cm in diameter, or multiple (maximum 3) tumors with at least one over 3cm but only one of the multiple tumors larger than 5cm for concerning too prolonged time of rfa. all the target tumors are located in single lobe.
Descrição

Tumor stage | Single tumor Diameter | Multiple tumors Maximum | Tumor size | Tumors Location Lobe Single

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1300072
UMLS CUI [2,1]
C1298180
UMLS CUI [2,2]
C1301886
UMLS CUI [3,1]
C0260037
UMLS CUI [3,2]
C0806909
UMLS CUI [4]
C0475440
UMLS CUI [5,1]
C0027651
UMLS CUI [5,2]
C1515974
UMLS CUI [5,3]
C0796494
UMLS CUI [5,4]
C0205171
the lesion should be detected on ultrasonography;
Descrição

Lesion Ultrasonography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0041618
the divergence of the hepatic artery was suitable for tace;
Descrição

Hepatic artery Suitable Transarterial Chemoembolization

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019145
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C3539919
absence of portal and venous thrombosis, extrahepatic metastases, or uncontrollable ascites;
Descrição

Portal vein thrombosis Absent | Venous Thrombosis Absent | Metastasis Extrahepatic Absent | Ascites Uncontrolled Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0155773
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0042487
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C1517058
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0003962
UMLS CUI [4,2]
C0205318
UMLS CUI [4,3]
C0332197
patients in child-pugh grade a or b;
Descrição

Child-Pugh Classification

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2347612
eastern cooperative oncology group performance status score of 2 or less;
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
patient has signed consent form regarding participation in the study.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients had previously received any treatment for hcc;
Descrição

Prior Therapy Liver carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C2239176
patients with known renal or cardiovascular disease before tace;
Descrição

Kidney Disease | Cardiovascular Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0007222
child-pugh grade c cirrhosis, prior decompensation and history of encephalopathy before tace
Descrição

Liver Cirrhosis Child-Pugh Classification | Hepatic decompensation | Hepatic Encephalopathy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C2347612
UMLS CUI [2]
C1394798
UMLS CUI [3]
C0019151
pregnancy or plan to pregnant in the subsequent study period (1 to 2 years)
Descrição

Pregnancy | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
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Similar models

Eligibility Hepatocellular Carcinoma NCT01858207

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 carcinoma unresectable | Liver carcinoma Resectable | Patients Inappropriate Excision
Item
unresectable hcc or patients with resectable hcc but not appropriate for resection;.
boolean
C2239176 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C1514888 (UMLS CUI [2,2])
C0030705 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0728940 (UMLS CUI [3,3])
Tumor stage | Single tumor Diameter | Multiple tumors Maximum | Tumor size | Tumors Location Lobe Single
Item
tumor stage: single tumor with 3.1-7cm in diameter, or multiple (maximum 3) tumors with at least one over 3cm but only one of the multiple tumors larger than 5cm for concerning too prolonged time of rfa. all the target tumors are located in single lobe.
boolean
C1300072 (UMLS CUI [1])
C1298180 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0260037 (UMLS CUI [3,1])
C0806909 (UMLS CUI [3,2])
C0475440 (UMLS CUI [4])
C0027651 (UMLS CUI [5,1])
C1515974 (UMLS CUI [5,2])
C0796494 (UMLS CUI [5,3])
C0205171 (UMLS CUI [5,4])
Lesion Ultrasonography
Item
the lesion should be detected on ultrasonography;
boolean
C0221198 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
Hepatic artery Suitable Transarterial Chemoembolization
Item
the divergence of the hepatic artery was suitable for tace;
boolean
C0019145 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C3539919 (UMLS CUI [1,3])
Portal vein thrombosis Absent | Venous Thrombosis Absent | Metastasis Extrahepatic Absent | Ascites Uncontrolled Absent
Item
absence of portal and venous thrombosis, extrahepatic metastases, or uncontrollable ascites;
boolean
C0155773 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0042487 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C1517058 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0003962 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Child-Pugh Classification
Item
patients in child-pugh grade a or b;
boolean
C2347612 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group performance status score of 2 or less;
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
patient has signed consent form regarding participation in the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Liver carcinoma
Item
patients had previously received any treatment for hcc;
boolean
C1514463 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
Kidney Disease | Cardiovascular Disease
Item
patients with known renal or cardiovascular disease before tace;
boolean
C0022658 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
Liver Cirrhosis Child-Pugh Classification | Hepatic decompensation | Hepatic Encephalopathy
Item
child-pugh grade c cirrhosis, prior decompensation and history of encephalopathy before tace
boolean
C0023890 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
C1394798 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
Pregnancy | Pregnancy, Planned
Item
pregnancy or plan to pregnant in the subsequent study period (1 to 2 years)
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
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