ID

42903

Descrição

Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Hepatocellular Carcinoma (HCC); ODM derived from: https://clinicaltrials.gov/show/NCT00484211

Link

https://clinicaltrials.gov/show/NCT00484211

Palavras-chave

Versões (2)
  1. 03/04/2017 03/04/2017 -
  2. 17/09/2021 17/09/2021 -
Transferido a

17 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00484211

Inglês

Eligibility Hepatocellular Carcinoma NCT00484211

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients >18 years affected by advanced or metastatic hcc previously treated with no more than one systemic therapeutic regimen
Descrição

Age | systemic therapy Quantity Advanced Adult Hepatocellular Carcinoma | systemic therapy Quantity Metastatic hepatocellular carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1706732
UMLS CUI [3,1]
C1515119
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0744869
histologically confirmed hcc not amenable to curative surgery
Descrição

Liver carcinoma Curative Surgery Amenable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1511562
UMLS CUI [1,3]
C3900053
child-pugh scale class a
Descrição

Child-Pugh Classification

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4050412
ecog performance status 0 - 1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
patients in progression disease at study entry ct documented
Descrição

Disease Progression X-Ray Computed Tomography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0040405
adequate baseline bone marrow, hepatic and renal function, defined as follows:
Descrição

Bone Marrow function | Liver function | Renal function

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
neutrophils > 1.5 x 10^9/l and platelets > 100 x 10^9/l
Descrição

Absolute neutrophil count | Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
bilirubin < 2 x uln
Descrição

Serum total bilirubin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
transaminases < 3 x uln
Descrição

Transaminases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002594
absence of any conditions in which hypervolaemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (reference appendix "technical data sheet human albumin")
Descrição

Fluid overload | Increased cardiac stroke volume | Increase in blood pressure | Hemodilution | Patient Risk Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0546817
UMLS CUI [2]
C0520872
UMLS CUI [3]
C0497247
UMLS CUI [4]
C0019009
UMLS CUI [5,1]
C0030705
UMLS CUI [5,2]
C0035647
UMLS CUI [5,3]
C0332197
normal cardiac function and absence of uncontrolled hypertension
Descrição

Cardiac function | Uncontrolled hypertension Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0332197
patients must give written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
decompensated cirrhosis (child-pugh score >7)
Descrição

Decompensated cirrhosis Child-Pugh Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1619727
UMLS CUI [1,2]
C4050412
concurrent anticancer therapy
Descrição

cancer treatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0920425
patients may not receive any other investigational agents while on study
Descrição

Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
clinical signs of cns involvement
Descrição

Central Nervous System Involvement Sign or Symptom

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C3540840
patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
Descrição

Systemic disease Uncontrolled | Sepsis Uncontrolled | Illness Serious Inconsistent Study Protocol | Medical condition Inconsistent Study Protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0243026
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0442809
UMLS CUI [3,4]
C2348563
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0442809
UMLS CUI [4,3]
C2348563
known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
Descrição

Hypersensitivity Human Albumin | Hypersensitivity Human Albumin Excipient | Allergic Reaction Human Albumin | Allergic Reaction Human Albumin Excipient

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304925
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0304925
UMLS CUI [2,3]
C0015237
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0304925
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0304925
UMLS CUI [4,3]
C0015237
any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
Descrição

Mental condition Protocol Compliance Limited | Condition Familial Protocol Compliance Limited | Sociological Factors Protocol Compliance Limited | Geographic Factors Protocol Compliance Limited

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0241888
UMLS CUI [2,3]
C0525058
UMLS CUI [2,4]
C0439801
UMLS CUI [3,1]
C3850138
UMLS CUI [3,2]
C0525058
UMLS CUI [3,3]
C0439801
UMLS CUI [4,1]
C0017444
UMLS CUI [4,2]
C0525058
UMLS CUI [4,3]
C0439801
pregnancy or lactation. patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration
Descrição

Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods | Postmenopausal state | Sexual sterilization | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C4034483
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C0232970
UMLS CUI [5]
C0038288
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0430061
UMLS CUI [7,1]
C3831118
UMLS CUI [7,2]
C0430057
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Similar models

Eligibility Hepatocellular Carcinoma NCT00484211

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age | systemic therapy Quantity Advanced Adult Hepatocellular Carcinoma | systemic therapy Quantity Metastatic hepatocellular carcinoma
Item
patients >18 years affected by advanced or metastatic hcc previously treated with no more than one systemic therapeutic regimen
boolean
C0001779 (UMLS CUI [1])
C1515119 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1706732 (UMLS CUI [2,3])
C1515119 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0744869 (UMLS CUI [3,3])
Liver carcinoma Curative Surgery Amenable
Item
histologically confirmed hcc not amenable to curative surgery
boolean
C2239176 (UMLS CUI [1,1])
C1511562 (UMLS CUI [1,2])
C3900053 (UMLS CUI [1,3])
Child-Pugh Classification
Item
child-pugh scale class a
boolean
C4050412 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0 - 1
boolean
C1520224 (UMLS CUI [1])
Disease Progression X-Ray Computed Tomography
Item
patients in progression disease at study entry ct documented
boolean
C0242656 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
Bone Marrow function | Liver function | Renal function
Item
adequate baseline bone marrow, hepatic and renal function, defined as follows:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Absolute neutrophil count | Platelet Count measurement
Item
neutrophils > 1.5 x 10^9/l and platelets > 100 x 10^9/l
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Serum total bilirubin measurement
Item
bilirubin < 2 x uln
boolean
C1278039 (UMLS CUI [1])
Transaminases
Item
transaminases < 3 x uln
boolean
C0002594 (UMLS CUI [1])
Fluid overload | Increased cardiac stroke volume | Increase in blood pressure | Hemodilution | Patient Risk Absent
Item
absence of any conditions in which hypervolaemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (reference appendix "technical data sheet human albumin")
boolean
C0546817 (UMLS CUI [1])
C0520872 (UMLS CUI [2])
C0497247 (UMLS CUI [3])
C0019009 (UMLS CUI [4])
C0030705 (UMLS CUI [5,1])
C0035647 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Cardiac function | Uncontrolled hypertension Absent
Item
normal cardiac function and absence of uncontrolled hypertension
boolean
C0232164 (UMLS CUI [1])
C1868885 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Informed Consent
Item
patients must give written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Decompensated cirrhosis Child-Pugh Classification
Item
decompensated cirrhosis (child-pugh score >7)
boolean
C1619727 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
cancer treatment
Item
concurrent anticancer therapy
boolean
C0920425 (UMLS CUI [1])
Investigational New Drugs
Item
patients may not receive any other investigational agents while on study
boolean
C0013230 (UMLS CUI [1])
Central Nervous System Involvement Sign or Symptom
Item
clinical signs of cns involvement
boolean
C4050309 (UMLS CUI [1,1])
C3540840 (UMLS CUI [1,2])
Systemic disease Uncontrolled | Sepsis Uncontrolled | Illness Serious Inconsistent Study Protocol | Medical condition Inconsistent Study Protocol
Item
patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
boolean
C0442893 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0243026 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0221423 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0442809 (UMLS CUI [3,3])
C2348563 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0442809 (UMLS CUI [4,2])
C2348563 (UMLS CUI [4,3])
Hypersensitivity Human Albumin | Hypersensitivity Human Albumin Excipient | Allergic Reaction Human Albumin | Allergic Reaction Human Albumin Excipient
Item
known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
boolean
C0020517 (UMLS CUI [1,1])
C0304925 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0304925 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C1527304 (UMLS CUI [3,1])
C0304925 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0304925 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Mental condition Protocol Compliance Limited | Condition Familial Protocol Compliance Limited | Sociological Factors Protocol Compliance Limited | Geographic Factors Protocol Compliance Limited
Item
any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
boolean
C3840291 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0241888 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
C3850138 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0017444 (UMLS CUI [4,1])
C0525058 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods | Postmenopausal state | Sexual sterilization | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
pregnancy or lactation. patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4])
C0038288 (UMLS CUI [5])
C3831118 (UMLS CUI [6,1])
C0430061 (UMLS CUI [6,2])
C3831118 (UMLS CUI [7,1])
C0430057 (UMLS CUI [7,2])
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