ID

40817

Descripción

Study of Sunitinib in Patients With Advanced/Inoperable Fibrolamellar Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01215565

Link

https://clinicaltrials.gov/show/NCT01215565

Palabras clave

Versiones (1)
  1. 18/5/20 18/5/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

18 de mayo de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01215565

Inglés

Eligibility Hepatocellular Carcinoma NCT01215565

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
fibrolamellar hepatocellular carcinoma histopathologically proven
Descripción

Fibrolamellar Hepatocellular Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0334287
inoperable/advanced (tumor recurrence inoperable or metastatic with no surgical indication).
Descripción

Inoperable | Advanced phase | Recurrent tumor Inoperable | Neoplasm Metastasis | Indication Absent Operative Surgical Procedures

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205187
UMLS CUI [2]
C0205179
UMLS CUI [3,1]
C0521158
UMLS CUI [3,2]
C0205187
UMLS CUI [4]
C0027627
UMLS CUI [5,1]
C3146298
UMLS CUI [5,2]
C0332197
UMLS CUI [5,3]
C0543467
available tumor tissue for analysis(biopsy or surgical specimen)
Descripción

Availability of Tumor tissue sample Analysis | Biopsy | Surgical specimen

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [1,3]
C0002778
UMLS CUI [2]
C0005558
UMLS CUI [3]
C1647891
performance status who ≤ 2.
Descripción

WHO performance status scale

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1298650
adequate organ function :
Descripción

Organ function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
hematology (absolute neutrophil count equal or superior to 1,5 x 10*9/l , platelet equal or superior to 100 x 10*9/l),
Descripción

Hematology | Absolute neutrophil count | Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0200627
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
clearance of creatinine > 60 ml/min),
Descripción

Creatinine clearance measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0373595
ast/alt ≤ 5 n, pal ≤ 5 n, total bilirubin ≤ 2n.
Descripción

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201850
UMLS CUI [4]
C1278039
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypersensitivity to sunitinib.
Descripción

Hypersensitivity Sunitinib

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176020
contraindication to sunitinib, including uncontrolled hypertension, medical history of cerebrovascular accident, unstable cardiac pathology despite optimal medical therapy (myocardial infarction within the 6 months prior to study drug administration, severe/unstable angina ), active hemorrhagic syndrome or concomitant treatment with anticoagulants.
Descripción

Medical contraindication Sunitinib | Uncontrolled hypertension | Cerebrovascular accident | Heart Disease Unstable | Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Hemorrhagic Disorders | Anticoagulant therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1176020
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0038454
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0443343
UMLS CUI [5]
C0027051
UMLS CUI [6,1]
C0002962
UMLS CUI [6,2]
C0205082
UMLS CUI [7]
C0002965
UMLS CUI [8]
C0019087
UMLS CUI [9]
C0150457
any severe acute or chronic co-morbid that may compromise to comply with study participation : uncontrolled infection, symptomatic congestive heart failure, liver disturbance, chronic renal failure, active gastro-duodenal ulcer (nonexhaustive list)
Descripción

Comorbidity Study Subject Participation Status At risk | Comorbidity chronic Study Subject Participation Status At risk | Communicable Disease Uncontrolled | Symptomatic congestive heart failure | Liver diseases | Kidney Failure, Chronic | Peptic Ulcer

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C1444641
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0742758
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0022661
UMLS CUI [7]
C0030920
known brain metastases.
Descripción

Metastatic malignant neoplasm to brain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
diagnosis of any second malignancy within the last 3 years, except for basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri
Descripción

Second Primary Cancer | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
current treatment on another clinical trial.
Descripción

Study Subject Participation Status | Clinical Trial Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0087111
prior treatment with an investigational agent within 4 weeks
Descripción

Prior Therapy Investigational New Drug

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0013230
patient on i.v bisphosphonate therapy
Descripción

Bisphosphonate therapy Intravenous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4510264
UMLS CUI [1,2]
C0348016
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Similar models

Eligibility Hepatocellular Carcinoma NCT01215565

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Fibrolamellar Hepatocellular Carcinoma
Item
fibrolamellar hepatocellular carcinoma histopathologically proven
boolean
C0334287 (UMLS CUI [1])
Inoperable | Advanced phase | Recurrent tumor Inoperable | Neoplasm Metastasis | Indication Absent Operative Surgical Procedures
Item
inoperable/advanced (tumor recurrence inoperable or metastatic with no surgical indication).
boolean
C0205187 (UMLS CUI [1])
C0205179 (UMLS CUI [2])
C0521158 (UMLS CUI [3,1])
C0205187 (UMLS CUI [3,2])
C0027627 (UMLS CUI [4])
C3146298 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0543467 (UMLS CUI [5,3])
Availability of Tumor tissue sample Analysis | Biopsy | Surgical specimen
Item
available tumor tissue for analysis(biopsy or surgical specimen)
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0002778 (UMLS CUI [1,3])
C0005558 (UMLS CUI [2])
C1647891 (UMLS CUI [3])
WHO performance status scale
Item
performance status who ≤ 2.
boolean
C1298650 (UMLS CUI [1])
Organ function
Item
adequate organ function :
boolean
C0678852 (UMLS CUI [1])
Hematology | Absolute neutrophil count | Platelet Count measurement
Item
hematology (absolute neutrophil count equal or superior to 1,5 x 10*9/l , platelet equal or superior to 100 x 10*9/l),
boolean
C0200627 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Creatinine clearance measurement
Item
clearance of creatinine > 60 ml/min),
boolean
C0373595 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement
Item
ast/alt ≤ 5 n, pal ≤ 5 n, total bilirubin ≤ 2n.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Sunitinib
Item
hypersensitivity to sunitinib.
boolean
C0020517 (UMLS CUI [1,1])
C1176020 (UMLS CUI [1,2])
Medical contraindication Sunitinib | Uncontrolled hypertension | Cerebrovascular accident | Heart Disease Unstable | Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Hemorrhagic Disorders | Anticoagulant therapy
Item
contraindication to sunitinib, including uncontrolled hypertension, medical history of cerebrovascular accident, unstable cardiac pathology despite optimal medical therapy (myocardial infarction within the 6 months prior to study drug administration, severe/unstable angina ), active hemorrhagic syndrome or concomitant treatment with anticoagulants.
boolean
C1301624 (UMLS CUI [1,1])
C1176020 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0027051 (UMLS CUI [5])
C0002962 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0002965 (UMLS CUI [7])
C0019087 (UMLS CUI [8])
C0150457 (UMLS CUI [9])
Comorbidity Study Subject Participation Status At risk | Comorbidity chronic Study Subject Participation Status At risk | Communicable Disease Uncontrolled | Symptomatic congestive heart failure | Liver diseases | Kidney Failure, Chronic | Peptic Ulcer
Item
any severe acute or chronic co-morbid that may compromise to comply with study participation : uncontrolled infection, symptomatic congestive heart failure, liver disturbance, chronic renal failure, active gastro-duodenal ulcer (nonexhaustive list)
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1444641 (UMLS CUI [2,4])
C0009450 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0742758 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0022661 (UMLS CUI [6])
C0030920 (UMLS CUI [7])
Metastatic malignant neoplasm to brain
Item
known brain metastases.
boolean
C0220650 (UMLS CUI [1])
Second Primary Cancer | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix
Item
diagnosis of any second malignancy within the last 3 years, except for basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
Study Subject Participation Status | Clinical Trial Therapy
Item
current treatment on another clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Prior Therapy Investigational New Drug
Item
prior treatment with an investigational agent within 4 weeks
boolean
C1514463 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Bisphosphonate therapy Intravenous
Item
patient on i.v bisphosphonate therapy
boolean
C4510264 (UMLS CUI [1,1])
C0348016 (UMLS CUI [1,2])
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