ID

44504

Beschreibung

Radiofrequency Ablation Combined With Transcatheter Arterial Chemoembolization Versus Radiofrequency Ablation Alone for Recurrent Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01415063

Link

https://clinicaltrials.gov/show/NCT01415063

Stichworte

Versionen (2)
  1. 19.02.20 19.02.20 -
  2. 27.09.21 27.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01415063

Englisch

Eligibility Hepatocellular Carcinoma NCT01415063

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18 - 75 years;
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. distant recurrence of hcc after initial curative treatment (including initial rfa or hepatectomy);
Beschreibung

Recurrent Hepatocellular Carcinoma | Status post Curative treatment Initial | Radiofrequency ablation Initial | Hepatectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0861876
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0205265
UMLS CUI [3,1]
C0850292
UMLS CUI [3,2]
C0205265
UMLS CUI [4]
C0019144
3. no other treatment received except for the initial rfa or hepatectomy;
Beschreibung

Patient untreated | Exception Radiofrequency ablation Initial | Exception Hepatectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0850292
UMLS CUI [2,3]
C0205265
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0019144
4. single tumor less than 4cm in diameter;
Beschreibung

Single tumor Diameter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1298180
UMLS CUI [1,2]
C1301886
5. lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound;
Beschreibung

Lesion Visible Ultrasonography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205379
UMLS CUI [1,3]
C0041618
6. no severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3;
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C3274435
UMLS CUI [3]
C0032181
7. eastern co-operative oncology group performance(ecog) status 0 -
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. the presence of vascular invasion or extrahepatic spread on imaging;
Beschreibung

Tumor Vascular Invasion Imaging | Spread Extrahepatic Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521157
UMLS CUI [1,2]
C0011923
UMLS CUI [2,1]
C0332261
UMLS CUI [2,2]
C1517058
UMLS CUI [2,3]
C0011923
2. a child-pugh class c liver cirrhosis or evidence of hepatic decompensation including ascites, severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3), esophageal or gastric variceal bleeding or hepatic encephalopathy;
Beschreibung

Liver Cirrhosis Child-Pugh Classification | Hepatic decompensation | Ascites | Blood Coagulation Disorders Severe | Prothrombin Activity Measurement | Platelet Count measurement | Bleeding esophageal varices | Bleeding gastric varices | Hepatic Encephalopathy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C4050412
UMLS CUI [2]
C1394798
UMLS CUI [3]
C0003962
UMLS CUI [4,1]
C0005779
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C3274435
UMLS CUI [6]
C0032181
UMLS CUI [7]
C0155789
UMLS CUI [8]
C0267209
UMLS CUI [9]
C0019151
3. an american society of anesthesiologists (asa) score ≥ 3
Beschreibung

ASA physical status class

Datentyp

boolean

Alias
UMLS CUI [1]
C0578808
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Ähnliche Modelle

Eligibility Hepatocellular Carcinoma NCT01415063

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 18 - 75 years;
boolean
C0001779 (UMLS CUI [1])
Recurrent Hepatocellular Carcinoma | Status post Curative treatment Initial | Radiofrequency ablation Initial | Hepatectomy
Item
2. distant recurrence of hcc after initial curative treatment (including initial rfa or hepatectomy);
boolean
C0861876 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0205265 (UMLS CUI [2,3])
C0850292 (UMLS CUI [3,1])
C0205265 (UMLS CUI [3,2])
C0019144 (UMLS CUI [4])
Patient untreated | Exception Radiofrequency ablation Initial | Exception Hepatectomy
Item
3. no other treatment received except for the initial rfa or hepatectomy;
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0850292 (UMLS CUI [2,2])
C0205265 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0019144 (UMLS CUI [3,2])
Single tumor Diameter
Item
4. single tumor less than 4cm in diameter;
boolean
C1298180 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
Lesion Visible Ultrasonography
Item
5. lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound;
boolean
C0221198 (UMLS CUI [1,1])
C0205379 (UMLS CUI [1,2])
C0041618 (UMLS CUI [1,3])
Blood Coagulation Disorders Severe Absent | Prothrombin Activity Measurement | Platelet Count measurement
Item
6. no severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3;
boolean
C0005779 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3274435 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
ECOG performance status
Item
7. eastern co-operative oncology group performance(ecog) status 0 -
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Tumor Vascular Invasion Imaging | Spread Extrahepatic Imaging
Item
1. the presence of vascular invasion or extrahepatic spread on imaging;
boolean
C0521157 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0332261 (UMLS CUI [2,1])
C1517058 (UMLS CUI [2,2])
C0011923 (UMLS CUI [2,3])
Liver Cirrhosis Child-Pugh Classification | Hepatic decompensation | Ascites | Blood Coagulation Disorders Severe | Prothrombin Activity Measurement | Platelet Count measurement | Bleeding esophageal varices | Bleeding gastric varices | Hepatic Encephalopathy
Item
2. a child-pugh class c liver cirrhosis or evidence of hepatic decompensation including ascites, severe coagulation disorders (prothrombin activity < 40% or a platelet count of < 40,000 / mm3), esophageal or gastric variceal bleeding or hepatic encephalopathy;
boolean
C0023890 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
C1394798 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C0005779 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C3274435 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
C0155789 (UMLS CUI [7])
C0267209 (UMLS CUI [8])
C0019151 (UMLS CUI [9])
ASA physical status class
Item
3. an american society of anesthesiologists (asa) score ≥ 3
boolean
C0578808 (UMLS CUI [1])
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