ID

44419

Descrição

Combination Treatment for Advanced Liver Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02149771

Link

https://clinicaltrials.gov/show/NCT02149771

Palavras-chave

Versões (4)
  1. 16/01/2019 16/01/2019 -
  2. 26/04/2020 26/04/2020 -
  3. 01/05/2020 01/05/2020 -
  4. 20/09/2021 20/09/2021 -
Titular dos direitos

Shanghai Zhongshan Hospital

Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY-NC 4.0
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Eligibility Hepatocellular Carcinoma NCT02149771

Inglês

Eligibility Hepatocellular Carcinoma NCT02149771

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
(1) hepatocellular carcinoma(hcc) diagnosis confirmed by needle biopsy or by two coincidental imaging techniques associated with increased α-fetoprotein according to the american association for the study of liver diseases (aasld) guidelines and contrast-enhancing tumour thrombus within the main portal vein and one of the first-order branch on ct or mri;
Descrição

HCC puncture biopsy | HCC imaging techniques associated with AFP | Portal venous trunk tumor thrombus or Portal vein first branch thrombus on CT or MRI with contrast enhancement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0936232
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0079595
UMLS CUI [2,3]
C0332281
UMLS CUI [2,4]
C0201539
UMLS CUI [3,1]
C1183135
UMLS CUI [3,2]
C3163918
UMLS CUI [3,3]
C0742919
UMLS CUI [4,1]
C1183135
UMLS CUI [4,2]
C3163918
UMLS CUI [4,3]
C1707501
UMLS CUI [5,1]
C0155773
UMLS CUI [5,2]
C1253959
UMLS CUI [5,3]
C0205435
UMLS CUI [5,4]
C0742919
UMLS CUI [6,1]
C0155773
UMLS CUI [6,2]
C1253959
UMLS CUI [6,3]
C0205435
UMLS CUI [6,4]
C1707501
(2) child-pugh classification grade a or b；
Descrição

Child-Pugh Classification

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4050412
（3）eastern cooperative oncology group (ecog) performance status score of 2 or less.
Descrição

ECOG Performance Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
advanced liver disease (bilirubin levels >3 mg/dl, ast or alt >5 × upper limit of normal)；
Descrição

Advanced liver disease | total bilirubin measurement | AST | ALT

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0201913
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
tumor invade the inferior vena cava, extrahepatic spread;
Descrição

Tumor invading the inferior vena cava | extrahepatic tumor spread

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1269955
UMLS CUI [1,2]
C0042458
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1517058
UMLS CUI [2,3]
C0332261
contraindications for doxorubicin or oxaliplatin chemotherapy;
Descrição

Contraindication doxorubicin | Contraindication oxaliplatin

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013089
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0069717
any contraindication to an arterial procedure such as impaired clotting tests (platelet count below 50 × 109/l or prothrombin activity below 50 %);
Descrição

Contraindication to procedures on arteries | Clotting tests Impaired | Platelet count | Prothrombin activity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0397581
UMLS CUI [1,2]
C1301624
UMLS CUI [2,1]
C0005778
UMLS CUI [2,2]
C0221099
UMLS CUI [3]
C0032181
UMLS CUI [4]
C3274435
renal failure,cardiac ejection fraction <50 percent or end-stage disease；
Descrição

Renal failure | cardiac ejection fraction | end-stage disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0232174
UMLS CUI [3,1]
C0205088
UMLS CUI [3,2]
C0012634
patients who were not capable of cooperation during the procedure.
Descrição

Cooperation Unable During Therapeutical procedure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392337
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0087111
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Similar models

Eligibility Hepatocellular Carcinoma NCT02149771

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
HCC puncture biopsy | HCC imaging techniques associated with AFP | Portal venous trunk tumor thrombus or Portal vein first branch thrombus on CT or MRI with contrast enhancement
Item
(1) hepatocellular carcinoma(hcc) diagnosis confirmed by needle biopsy or by two coincidental imaging techniques associated with increased α-fetoprotein according to the american association for the study of liver diseases (aasld) guidelines and contrast-enhancing tumour thrombus within the main portal vein and one of the first-order branch on ct or mri;
boolean
C2239176 (UMLS CUI [1,1])
C0936232 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0079595 (UMLS CUI [2,2])
C0332281 (UMLS CUI [2,3])
C0201539 (UMLS CUI [2,4])
C1183135 (UMLS CUI [3,1])
C3163918 (UMLS CUI [3,2])
C0742919 (UMLS CUI [3,3])
C1183135 (UMLS CUI [4,1])
C3163918 (UMLS CUI [4,2])
C1707501 (UMLS CUI [4,3])
C0155773 (UMLS CUI [5,1])
C1253959 (UMLS CUI [5,2])
C0205435 (UMLS CUI [5,3])
C0742919 (UMLS CUI [5,4])
C0155773 (UMLS CUI [6,1])
C1253959 (UMLS CUI [6,2])
C0205435 (UMLS CUI [6,3])
C1707501 (UMLS CUI [6,4])
Child-Pugh Classification
Item
(2) child-pugh classification grade a or b；
boolean
C4050412 (UMLS CUI [1])
ECOG Performance Status
Item
（3）eastern cooperative oncology group (ecog) performance status score of 2 or less.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Advanced liver disease | total bilirubin measurement | AST | ALT
Item
advanced liver disease (bilirubin levels >3 mg/dl, ast or alt >5 × upper limit of normal)；
boolean
C0023895 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0201913 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Tumor invading the inferior vena cava | extrahepatic tumor spread
Item
tumor invade the inferior vena cava, extrahepatic spread;
boolean
C1269955 (UMLS CUI [1,1])
C0042458 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C1517058 (UMLS CUI [2,2])
C0332261 (UMLS CUI [2,3])
Contraindication doxorubicin | Contraindication oxaliplatin
Item
contraindications for doxorubicin or oxaliplatin chemotherapy;
boolean
C1301624 (UMLS CUI [1,1])
C0013089 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0069717 (UMLS CUI [2,2])
Contraindication to procedures on arteries | Clotting tests Impaired | Platelet count | Prothrombin activity
Item
any contraindication to an arterial procedure such as impaired clotting tests (platelet count below 50 × 109/l or prothrombin activity below 50 %);
boolean
C0397581 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0005778 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0032181 (UMLS CUI [3])
C3274435 (UMLS CUI [4])
Renal failure | cardiac ejection fraction | end-stage disease
Item
renal failure,cardiac ejection fraction <50 percent or end-stage disease；
boolean
C0035078 (UMLS CUI [1])
C0232174 (UMLS CUI [2])
C0205088 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
Cooperation Unable During Therapeutical procedure
Item
patients who were not capable of cooperation during the procedure.
boolean
C0392337 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
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