ID

40493

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02149771

Nyckelord

Versioner (4)
  1. 2019-01-16 2019-01-16 -
  2. 2020-04-26 2020-04-26 -
  3. 2020-05-01 2020-05-01 -
  4. 2021-09-20 2021-09-20 -
Rättsinnehavare

Shanghai Zhongshan Hospital

Uppladdad den

26 april 2020

DOI

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Licens

Creative Commons BY-NC 4.0
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Eligibility Hepatocellular Carcinoma NCT02149771

Engelsk

Eligibility Hepatocellular Carcinoma NCT02149771

1 Formulär  
Inclusion Criteria
Beskrivning

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;
Beskrivning

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

Datatyp

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 [4,1]
C0155773
UMLS CUI [4,2]
C1253959
UMLS CUI [4,3]
C0205435
UMLS CUI [5]
C1707501
UMLS CUI [6]
C0742919
(2) child-pugh classification grade a or b；
Beskrivning

Child-Pugh Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C2347612
（3）eastern cooperative oncology group (ecog) performance status score of 2 or less.
Beskrivning

ECOG Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Advanced liver disease | total bilirubin measurement | AST, ALT upper limit of normal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0201913
UMLS CUI [3,1]
C0201899
UMLS CUI [3,2]
C1519815
UMLS CUI [4,1]
C0201836
UMLS CUI [4,2]
C1519815
tumor invade the inferior vena cava, extrahepatic spread;
Beskrivning

Tumor invading the inferior vena cava | extrahepatic tumor spread

Datatyp

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;
Beskrivning

Contraindication doxorubicin | Contraindication oxaliplatin

Datatyp

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 %);
Beskrivning

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

Datatyp

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；
Beskrivning

Renal failure | cardiac ejection fraction | end-stage disease

Datatyp

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.
Beskrivning

Cooperation Unable During Therapeutical procedure

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
HCC puncture biopsy | HCC imaging techniques associated with AFP | Portal venous trunk tumor thrombus | Portal vein first branch thrombus | CT or MRI 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])
C0155773 (UMLS CUI [4,1])
C1253959 (UMLS CUI [4,2])
C0205435 (UMLS CUI [4,3])
C1707501 (UMLS CUI [5])
C0742919 (UMLS CUI [6])
Child-Pugh Classification
Item
(2) child-pugh classification grade a or b；
boolean
C2347612 (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 upper limit of normal
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 [3,1])
C1519815 (UMLS CUI [3,2])
C0201836 (UMLS CUI [4,1])
C1519815 (UMLS CUI [4,2])
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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