ID

39810

Beschreibung

P2 Study of Postoperative Interferon/Fluorouracil vs Cisplatin/Fluorouracil for Hepatocellular Carcinoma.; ODM derived from: https://clinicaltrials.gov/show/NCT01834963

Link

https://clinicaltrials.gov/show/NCT01834963

Stichworte

Versionen (2)
  1. 22.02.20 22.02.20 -
  2. 27.09.21 27.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

22. Februar 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01834963

Englisch

Eligibility Hepatocellular Carcinoma NCT01834963

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. hepatocellular carcinoma with histological or evidence or typical findings by ct or mri.
Beschreibung

Liver carcinoma CT | Liver carcinoma MRI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0024485
2. surgically resectable tumors with tumor thrombus in first branch or main trunk of portal vein.
Beschreibung

Tumors Resectable | Tumor thrombus First Branch of portal vein | Tumor thrombus Main portal venous trunk

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1514888
UMLS CUI [2,1]
C3163918
UMLS CUI [2,2]
C0226736
UMLS CUI [2,3]
C0205435
UMLS CUI [3,1]
C3163918
UMLS CUI [3,2]
C1183135
3. 20 years old or more.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. eastern cooperative oncology group performance status of 0 or 1.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
5. life expectancy of at least 6 months at the pre-treatment evaluation.
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
6. child-pugh class a or b.
Beschreibung

Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C2347612
7. adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements.
Beschreibung

Bone Marrow function | Liver function | Renal function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
white blood cell count >= 2000/microliter, neutrophil >= 1000/microliter, hemoglobin >= 9.0 g/dl, platelet count >= 75000/microliter, total bilirubin <= 1.5mg/dl, aspartate aminotransferase(ast) /alanine aminotransferase(alt) <= 150 iu/l, serum creatinine <= 1.2mg/dl, creatinine clearance >= 60 ml/min
Beschreibung

White Blood Cell Count procedure | Neutrophil count | Hemoglobin measurement | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum | Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0032181
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201836
UMLS CUI [8]
C0201976
UMLS CUI [9]
C0373595
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. histological diagnosed combined hepatocellular and cholangiocellular carcinoma.
Beschreibung

Combination Liver carcinoma Cholangiocarcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205195
UMLS CUI [1,2]
C2239176
UMLS CUI [1,3]
C0206698
2. extrahepatic tumor spread which affects patient's prognosis.
Beschreibung

Tumor Spread Extrahepatic | Involvement with Prognosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0332261
UMLS CUI [1,3]
C1517058
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0033325
3. hepatic encephalopathy
Beschreibung

Hepatic Encephalopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0019151
4. active infections except for hepatitis b virus(hbv) and hepatitis c virus(hcv).
Beschreibung

Communicable Diseases | Exception Hepatitis B | Exception Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019163
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0019196
5. sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)
Beschreibung

Severe complication | Pneumonia, Interstitial | Heart failure | Kidney Failure | Liver Failure | Ileus | Diabetic - poor control

Datentyp

boolean

Alias
UMLS CUI [1]
C3495031
UMLS CUI [2]
C0206061
UMLS CUI [3]
C0018801
UMLS CUI [4]
C0035078
UMLS CUI [5]
C0085605
UMLS CUI [6]
C1258215
UMLS CUI [7]
C0421258
6. active double cancer
Beschreibung

Malignant Neoplasm Double

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205173
7. pregnancy 8-10) medication or treatment that may affect to the absorption of drug or pharmacokinetics.
Beschreibung

Pregnancy | Pharmaceutical Preparations Affecting Drug absorption | Therapy Affecting Drug absorption | Pharmaceutical Preparations Affecting Pharmacokinetics | Therapeutic procedure Affecting Pharmacokinetics

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0678745
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0678745
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0031327
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0031327
11) others, in the investigator's judgment.
Beschreibung

Eligibility Criteria Additional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
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Ähnliche Modelle

Eligibility Hepatocellular Carcinoma NCT01834963

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma CT | Liver carcinoma MRI
Item
1. hepatocellular carcinoma with histological or evidence or typical findings by ct or mri.
boolean
C2239176 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
Tumors Resectable | Tumor thrombus First Branch of portal vein | Tumor thrombus Main portal venous trunk
Item
2. surgically resectable tumors with tumor thrombus in first branch or main trunk of portal vein.
boolean
C0027651 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C3163918 (UMLS CUI [2,1])
C0226736 (UMLS CUI [2,2])
C0205435 (UMLS CUI [2,3])
C3163918 (UMLS CUI [3,1])
C1183135 (UMLS CUI [3,2])
Age
Item
3. 20 years old or more.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4. eastern cooperative oncology group performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
5. life expectancy of at least 6 months at the pre-treatment evaluation.
boolean
C0023671 (UMLS CUI [1])
Child-Pugh Classification
Item
6. child-pugh class a or b.
boolean
C2347612 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function
Item
7. adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
White Blood Cell Count procedure | Neutrophil count | Hemoglobin measurement | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum | Creatinine clearance measurement
Item
white blood cell count >= 2000/microliter, neutrophil >= 1000/microliter, hemoglobin >= 9.0 g/dl, platelet count >= 75000/microliter, total bilirubin <= 1.5mg/dl, aspartate aminotransferase(ast) /alanine aminotransferase(alt) <= 150 iu/l, serum creatinine <= 1.2mg/dl, creatinine clearance >= 60 ml/min
boolean
C0023508 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
C0373595 (UMLS CUI [9])
Item Group
C0680251 (UMLS CUI)
Combination Liver carcinoma Cholangiocarcinoma
Item
1. histological diagnosed combined hepatocellular and cholangiocellular carcinoma.
boolean
C0205195 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C0206698 (UMLS CUI [1,3])
Tumor Spread Extrahepatic | Involvement with Prognosis
Item
2. extrahepatic tumor spread which affects patient's prognosis.
boolean
C0027651 (UMLS CUI [1,1])
C0332261 (UMLS CUI [1,2])
C1517058 (UMLS CUI [1,3])
C1314939 (UMLS CUI [2,1])
C0033325 (UMLS CUI [2,2])
Hepatic Encephalopathy
Item
3. hepatic encephalopathy
boolean
C0019151 (UMLS CUI [1])
Communicable Diseases | Exception Hepatitis B | Exception Hepatitis C
Item
4. active infections except for hepatitis b virus(hbv) and hepatitis c virus(hcv).
boolean
C0009450 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
Severe complication | Pneumonia, Interstitial | Heart failure | Kidney Failure | Liver Failure | Ileus | Diabetic - poor control
Item
5. sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)
boolean
C3495031 (UMLS CUI [1])
C0206061 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
C0035078 (UMLS CUI [4])
C0085605 (UMLS CUI [5])
C1258215 (UMLS CUI [6])
C0421258 (UMLS CUI [7])
Malignant Neoplasm Double
Item
6. active double cancer
boolean
C0006826 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
Pregnancy | Pharmaceutical Preparations Affecting Drug absorption | Therapy Affecting Drug absorption | Pharmaceutical Preparations Affecting Pharmacokinetics | Therapeutic procedure Affecting Pharmacokinetics
Item
7. pregnancy 8-10) medication or treatment that may affect to the absorption of drug or pharmacokinetics.
boolean
C0032961 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0678745 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0678745 (UMLS CUI [3,3])
C0013227 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0031327 (UMLS CUI [4,3])
C0087111 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0031327 (UMLS CUI [5,3])
Eligibility Criteria Additional
Item
11) others, in the investigator's judgment.
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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