ID

39816

Descripción

The Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01953406

Link

https://clinicaltrials.gov/show/NCT01953406

Palabras clave

Versiones (2)
  1. 23/2/20 23/2/20 -
  2. 27/9/21 27/9/21 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

23 de febrero de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01953406

Inglés

Eligibility Hepatocellular Carcinoma NCT01953406

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who have received previous local therapy treatments for the intrahepatic hepatocellular carcinoma (rfa, pei, cryoablation, surgery, resection) and who don't have any viable intrahepatic tumor within 3 months of imaging (dynamic liver ct or liver mri) after the locoregional therapy
Descripción

Local Therapy Liver carcinoma intrahepatic | Radiofrequency ablation | Ethanol Ablation Therapy | Cryosurgery | Operative Surgical Procedures | Excision | Tumor intrahepatic Absent | CT of Liver | MRI of Liver

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1517925
UMLS CUI [1,2]
C2239176
UMLS CUI [1,3]
C1512948
UMLS CUI [2]
C0850292
UMLS CUI [3]
C1880568
UMLS CUI [4]
C0010408
UMLS CUI [5]
C0543467
UMLS CUI [6]
C0728940
UMLS CUI [7,1]
C0027651
UMLS CUI [7,2]
C1512948
UMLS CUI [7,3]
C0332197
UMLS CUI [8]
C0412621
UMLS CUI [9]
C0412694
patients who have measurable lung metastasis
Descripción

Secondary malignant neoplasm of lung Measurable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0153676
UMLS CUI [1,2]
C1513040
patients who have received their last dose of sorafenib more than 14 days before and who had progressive disease of lung metastasis with sorafenib
Descripción

Sorafenib Previous | Secondary malignant neoplasm of lung Progressive Disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1516119
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0153676
UMLS CUI [2,2]
C1335499
patients who have risk factors of hepatocellular carcinoma (chronic hepatitis b, chronic hepatitis c, liver cirrhosis)
Descripción

Risk factors Liver carcinoma | Hepatitis B, Chronic | Hepatitis C, Chronic | Liver Cirrhosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C2239176
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0524910
UMLS CUI [4]
C0023890
age : 18 years to 80 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0 to 2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
child-pugh class a,b (child-pugh score 5-9)
Descripción

Child-Pugh Classification | Child-Pugh Score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347612
UMLS CUI [2]
C4055253
adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
Descripción

Bone Marrow function | Laboratory Requirement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2,1]
C0022885
UMLS CUI [2,2]
C1514873
wbc count > 1,000/mm3
Descripción

White Blood Cell Count procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023508
absolute neutrophil count > 500/mm3
Descripción

Absolute neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948762
hb > 7.0 g/dl
Descripción

Hemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518015
platelet count > 50,000 /mm3
Descripción

Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
bilirubin < 3 mg/dl
Descripción

Serum total bilirubin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
adequate clotting function: inr < 2.3 or < 6sec
Descripción

Clotting function | International Normalized Ratio

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005778
UMLS CUI [2]
C0525032
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
child-pugh score > 10
Descripción

Child-Pugh Score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4055253
ecog performance status > 3
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
history of organ allograft
Descripción

Organ allograft

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0040739
patients with uncontrolled co-morbidity which needs treatment
Descripción

Comorbidity Uncontrolled | Treatment required

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0332121
patients who have received prior systemic chemotherapy except sorafenib
Descripción

Systemic Chemotherapy | Exception Sorafenib

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1883256
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1516119
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Similar models

Eligibility Hepatocellular Carcinoma NCT01953406

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Local Therapy Liver carcinoma intrahepatic | Radiofrequency ablation | Ethanol Ablation Therapy | Cryosurgery | Operative Surgical Procedures | Excision | Tumor intrahepatic Absent | CT of Liver | MRI of Liver
Item
patients who have received previous local therapy treatments for the intrahepatic hepatocellular carcinoma (rfa, pei, cryoablation, surgery, resection) and who don't have any viable intrahepatic tumor within 3 months of imaging (dynamic liver ct or liver mri) after the locoregional therapy
boolean
C1517925 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C1512948 (UMLS CUI [1,3])
C0850292 (UMLS CUI [2])
C1880568 (UMLS CUI [3])
C0010408 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
C0728940 (UMLS CUI [6])
C0027651 (UMLS CUI [7,1])
C1512948 (UMLS CUI [7,2])
C0332197 (UMLS CUI [7,3])
C0412621 (UMLS CUI [8])
C0412694 (UMLS CUI [9])
Secondary malignant neoplasm of lung Measurable
Item
patients who have measurable lung metastasis
boolean
C0153676 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
Sorafenib Previous | Secondary malignant neoplasm of lung Progressive Disease
Item
patients who have received their last dose of sorafenib more than 14 days before and who had progressive disease of lung metastasis with sorafenib
boolean
C1516119 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0153676 (UMLS CUI [2,1])
C1335499 (UMLS CUI [2,2])
Risk factors Liver carcinoma | Hepatitis B, Chronic | Hepatitis C, Chronic | Liver Cirrhosis
Item
patients who have risk factors of hepatocellular carcinoma (chronic hepatitis b, chronic hepatitis c, liver cirrhosis)
boolean
C0035648 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C0524909 (UMLS CUI [2])
C0524910 (UMLS CUI [3])
C0023890 (UMLS CUI [4])
Age
Item
age : 18 years to 80 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0 to 2
boolean
C1520224 (UMLS CUI [1])
Child-Pugh Classification | Child-Pugh Score
Item
child-pugh class a,b (child-pugh score 5-9)
boolean
C2347612 (UMLS CUI [1])
C4055253 (UMLS CUI [2])
Bone Marrow function | Laboratory Requirement
Item
adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
White Blood Cell Count procedure
Item
wbc count > 1,000/mm3
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count > 500/mm3
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement
Item
hb > 7.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count > 50,000 /mm3
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin < 3 mg/dl
boolean
C1278039 (UMLS CUI [1])
Clotting function | International Normalized Ratio
Item
adequate clotting function: inr < 2.3 or < 6sec
boolean
C0005778 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Child-Pugh Score
Item
child-pugh score > 10
boolean
C4055253 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status > 3
boolean
C1520224 (UMLS CUI [1])
Organ allograft
Item
history of organ allograft
boolean
C0178784 (UMLS CUI [1,1])
C0040739 (UMLS CUI [1,2])
Comorbidity Uncontrolled | Treatment required
Item
patients with uncontrolled co-morbidity which needs treatment
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0332121 (UMLS CUI [2])
Systemic Chemotherapy | Exception Sorafenib
Item
patients who have received prior systemic chemotherapy except sorafenib
boolean
C1883256 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1516119 (UMLS CUI [2,2])
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