ID

36065

Beschrijving

Early Recurrence Risk Factors of Early-Stage Hepatocellular Carcinoma After Radio Frequency Ablation; ODM derived from: https://clinicaltrials.gov/show/NCT02046356

Link

https://clinicaltrials.gov/show/NCT02046356

Trefwoorden

Versies (2)
  1. 12-04-19 12-04-19 -
  2. 20-09-21 20-09-21 -
Houder van rechten

See clinicaltrials.gov

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12 april 2019

DOI

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Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT02046356

Engels

Eligibility Hepatocellular Carcinoma NCT02046356

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
18-70 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
the diameter of single tumor should be no more than 5cm, or multiple tumors(less than 3 loci) should be no more than 3cm. no large vascular invasion, no lymph nodes or extrahepatic metastases
Beschrijving

Tumor Diameter | Multiple tumors Diameter | Tumor Vascular Invasion Large Absent | Secondary malignant neoplasm of lymph node Absent | Neoplasm Metastasis Extrahepatic Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1301886
UMLS CUI [2,1]
C0260037
UMLS CUI [2,2]
C1301886
UMLS CUI [3,1]
C0521157
UMLS CUI [3,2]
C0549177
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0686619
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0027627
UMLS CUI [5,2]
C1517058
UMLS CUI [5,3]
C0332197
the classification of patients' liver function is child - pugh a or b
Beschrijving

Liver function Child-Pugh Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C2347612
no serious coagulation dysfunction (prothrombin activity < 40% or platelet count < 30000 / ml).
Beschrijving

Blood Coagulation Disorders Serious Absent | Prothrombin Activity Measurement | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C3274435
UMLS CUI [3]
C0032181
no refractory ascites.
Beschrijving

Refractory ascites Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C3532188
UMLS CUI [1,2]
C0332197
the patients can be treated with rfa in clinical
Beschrijving

Radiofrequency ablation

Datatype

boolean

Alias
UMLS CUI [1]
C0850292
primary treatment by rfa should ablate the tumor(s) completely
Beschrijving

Radiofrequency ablation Primary | Ablation of liver tumor Complete

Datatype

boolean

Alias
UMLS CUI [1,1]
C0850292
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C2004650
UMLS CUI [2,2]
C0205197
the patients are aware of their condition, the treatment of the hcc, and the risks associated with radiofrequency ablation therapy.
Beschrijving

Comprehension Study Protocol | Therapy Liver carcinoma | Risk Associated with Radiofrequency ablation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2239176
UMLS CUI [3,1]
C0035647
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0850292
the patients participant voluntarily and they will sign the informed consent before the
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patients are from abroad, hong kong, macao, taiwan and other regions, who are impossible to be follow-up
Beschrijving

Residence Remote | Patients Unavailable Follow-up

Datatype

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0205157
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0686905
UMLS CUI [2,3]
C3274571
the patients who refuse to sign the informed consent
Beschrijving

Informed Consent Refused

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
tumor emboli existed in main portal vein, ductus hepatics communis and(or) its primary branch, main hepatic vein and(or) inferior vena cava before operation
Beschrijving

Tumor Embolism Main portal vein | Tumor Embolism Common Hepatic Duct | Tumor Embolism Hepatic vein Main | Tumor Embolism Inferior vena cava | Status pre- Operative Surgical Procedures

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013930
UMLS CUI [1,2]
C1183135
UMLS CUI [2,1]
C0013930
UMLS CUI [2,2]
C0019149
UMLS CUI [3,1]
C0013930
UMLS CUI [3,2]
C0019155
UMLS CUI [3,3]
C1542147
UMLS CUI [4,1]
C0013930
UMLS CUI [4,2]
C0042458
UMLS CUI [5,1]
C0332152
UMLS CUI [5,2]
C0543467
extrahepatic metastasis, lymph node metastasis
Beschrijving

Neoplasm Metastasis Extrahepatic | Secondary malignant neoplasm of lymph node

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517058
UMLS CUI [2]
C0686619
the patients whom accept systemic chemotherapy, preoperative interventional therapy, and(or) other auxiliary treatment
Beschrijving

Systemic Chemotherapy | Interventional procedure Preoperative | Adjuvant therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1883256
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C0445204
UMLS CUI [3]
C0677850
the patients with diabetes mellitus, heart disease and(or) other diseases can't tolerate radiofrequency ablation, or influence postoperative follow-up
Beschrijving

Radiofrequency ablation Inconsistent Diabetes Mellitus | Radiofrequency ablation Inconsistent Heart Diseases | Radiofrequency ablation Inconsistent Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0850292
UMLS CUI [1,2]
C0442809
UMLS CUI [1,3]
C0011849
UMLS CUI [2,1]
C0850292
UMLS CUI [2,2]
C0442809
UMLS CUI [2,3]
C0018799
UMLS CUI [3,1]
C0850292
UMLS CUI [3,2]
C0442809
UMLS CUI [3,3]
C0012634
the existence of other type of malignant tumor before or accompanied by hcc
Beschrijving

Cancer Other Before Liver carcinoma | Cancer Other Associated with Liver carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C2239176
UMLS CUI [2,1]
C1707251
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C2239176
primary treatment by rfa do not ablate the tumor(s) completely
Beschrijving

Radiofrequency ablation Primary | Ablation of liver tumor Incomplete

Datatype

boolean

Alias
UMLS CUI [1,1]
C0850292
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C2004650
UMLS CUI [2,2]
C0205257
non-primary liver tumor, such as the liver metastatic carcinoma, cholangiocarcinoma, etc
Beschrijving

Liver neoplasms Except Primary tumor | Hepatic cancer metastatic | Cholangiocarcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023903
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0677930
UMLS CUI [2]
C0856554
UMLS CUI [3]
C0206698
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Similar models

Eligibility Hepatocellular Carcinoma NCT02046356

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18-70 years old
boolean
C0001779 (UMLS CUI [1])
Tumor Diameter | Multiple tumors Diameter | Tumor Vascular Invasion Large Absent | Secondary malignant neoplasm of lymph node Absent | Neoplasm Metastasis Extrahepatic Absent
Item
the diameter of single tumor should be no more than 5cm, or multiple tumors(less than 3 loci) should be no more than 3cm. no large vascular invasion, no lymph nodes or extrahepatic metastases
boolean
C0027651 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0260037 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0521157 (UMLS CUI [3,1])
C0549177 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0686619 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0027627 (UMLS CUI [5,1])
C1517058 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Liver function Child-Pugh Classification
Item
the classification of patients' liver function is child - pugh a or b
boolean
C0232741 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
Blood Coagulation Disorders Serious Absent | Prothrombin Activity Measurement | Platelet Count measurement
Item
no serious coagulation dysfunction (prothrombin activity < 40% or platelet count < 30000 / ml).
boolean
C0005779 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3274435 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Refractory ascites Absent
Item
no refractory ascites.
boolean
C3532188 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Radiofrequency ablation
Item
the patients can be treated with rfa in clinical
boolean
C0850292 (UMLS CUI [1])
Radiofrequency ablation Primary | Ablation of liver tumor Complete
Item
primary treatment by rfa should ablate the tumor(s) completely
boolean
C0850292 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C2004650 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Comprehension Study Protocol | Therapy Liver carcinoma | Risk Associated with Radiofrequency ablation
Item
the patients are aware of their condition, the treatment of the hcc, and the risks associated with radiofrequency ablation therapy.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
C0035647 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0850292 (UMLS CUI [3,3])
Informed Consent
Item
the patients participant voluntarily and they will sign the informed consent before the
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Residence Remote | Patients Unavailable Follow-up
Item
the patients are from abroad, hong kong, macao, taiwan and other regions, who are impossible to be follow-up
boolean
C0237096 (UMLS CUI [1,1])
C0205157 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0686905 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Informed Consent Refused
Item
the patients who refuse to sign the informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
Tumor Embolism Main portal vein | Tumor Embolism Common Hepatic Duct | Tumor Embolism Hepatic vein Main | Tumor Embolism Inferior vena cava | Status pre- Operative Surgical Procedures
Item
tumor emboli existed in main portal vein, ductus hepatics communis and(or) its primary branch, main hepatic vein and(or) inferior vena cava before operation
boolean
C0013930 (UMLS CUI [1,1])
C1183135 (UMLS CUI [1,2])
C0013930 (UMLS CUI [2,1])
C0019149 (UMLS CUI [2,2])
C0013930 (UMLS CUI [3,1])
C0019155 (UMLS CUI [3,2])
C1542147 (UMLS CUI [3,3])
C0013930 (UMLS CUI [4,1])
C0042458 (UMLS CUI [4,2])
C0332152 (UMLS CUI [5,1])
C0543467 (UMLS CUI [5,2])
Neoplasm Metastasis Extrahepatic | Secondary malignant neoplasm of lymph node
Item
extrahepatic metastasis, lymph node metastasis
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C0686619 (UMLS CUI [2])
Systemic Chemotherapy | Interventional procedure Preoperative | Adjuvant therapy
Item
the patients whom accept systemic chemotherapy, preoperative interventional therapy, and(or) other auxiliary treatment
boolean
C1883256 (UMLS CUI [1])
C0184661 (UMLS CUI [2,1])
C0445204 (UMLS CUI [2,2])
C0677850 (UMLS CUI [3])
Radiofrequency ablation Inconsistent Diabetes Mellitus | Radiofrequency ablation Inconsistent Heart Diseases | Radiofrequency ablation Inconsistent Disease
Item
the patients with diabetes mellitus, heart disease and(or) other diseases can't tolerate radiofrequency ablation, or influence postoperative follow-up
boolean
C0850292 (UMLS CUI [1,1])
C0442809 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
C0850292 (UMLS CUI [2,1])
C0442809 (UMLS CUI [2,2])
C0018799 (UMLS CUI [2,3])
C0850292 (UMLS CUI [3,1])
C0442809 (UMLS CUI [3,2])
C0012634 (UMLS CUI [3,3])
Cancer Other Before Liver carcinoma | Cancer Other Associated with Liver carcinoma
Item
the existence of other type of malignant tumor before or accompanied by hcc
boolean
C1707251 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
C1707251 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C2239176 (UMLS CUI [2,3])
Radiofrequency ablation Primary | Ablation of liver tumor Incomplete
Item
primary treatment by rfa do not ablate the tumor(s) completely
boolean
C0850292 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C2004650 (UMLS CUI [2,1])
C0205257 (UMLS CUI [2,2])
Liver neoplasms Except Primary tumor | Hepatic cancer metastatic | Cholangiocarcinoma
Item
non-primary liver tumor, such as the liver metastatic carcinoma, cholangiocarcinoma, etc
boolean
C0023903 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,3])
C0856554 (UMLS CUI [2])
C0206698 (UMLS CUI [3])
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