ID

19593

Descrição

Efficacy and Safety of Imatinib and Vinorelbine in Patients With Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00372476

Link

https://clinicaltrials.gov/show/NCT00372476

Palavras-chave

Versões (1)
  1. 13/01/2017 13/01/2017 -
Transferido a

13 de janeiro de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Breast Cancer NCT00372476

Inglês

Eligibility Breast Cancer NCT00372476

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically documented diagnosis of invasive breast cancer that is locally advanced or metastatic
Descrição

Invasive carcinoma of breast Advanced Local | Invasive carcinoma of breast metastatic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0205276
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C1522484
previous anthracycline containing chemotherapy
Descrição

Chemotherapy Anthracycline Containing

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0282564
UMLS CUI [1,3]
C0332256
presence of a certain protein on the cell surface (c-kit (cd117) and /or pdgf-receptor)
Descrição

c-kit protein Cell surface | Platelet-Derived Growth Factor Receptor

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0072470
UMLS CUI [1,2]
C0699040
UMLS CUI [2]
C0071253
preferably tumor samples should be taken within 6 weeks of study entry. most recent primary tumor tissue has to be available for analysis
Descrição

Tumor tissue sample Available Analysis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0002778
acceptable health status (eastern cooperative oncology group [ecog]-performance status 0,1, 2 or 3)
Descrição

Health Status Acceptable ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018759
UMLS CUI [1,2]
C1879533
UMLS CUI [1,3]
C1520224
exclusion criteria: (for the second-line therapy)
Descrição

Exclusion Criteria Second line treatment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1710038
patient with grade iii/iv cardiac problems (i.e., congestive heart failure, myocardial infarction within 6 months of study) and with severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
Descrição

cardiac problem New York Heart Association Classification | Congestive heart failure | Myocardial Infarction | Disease Severe | Disease Uncontrolled | Diabetic - poor control | Chronic Kidney Disease | Communicable Disease Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0262402
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0205318
UMLS CUI [6]
C0421258
UMLS CUI [7]
C1561643
UMLS CUI [8,1]
C0009450
UMLS CUI [8,2]
C0205318
patient has a known brain metastasis, chronic liver disease (i.e., chronic active hepatitis, and cirrhosis) and diagnosis of (hiv) infection.
Descrição

Metastatic malignant neoplasm to brain | Chronic liver disease | Hepatitis, Chronic | Liver Cirrhosis chronic | Communicable Disease | HIV Infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0341439
UMLS CUI [3]
C0019189
UMLS CUI [4,1]
C0023890
UMLS CUI [4,2]
C0205191
UMLS CUI [5]
C0009450
UMLS CUI [6]
C0019693
patient received chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing.
Descrição

Chemotherapy | Rapid disease progression

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1834700
patient previously received radiotherapy to ≥ 25 % of the bone marrow and had a major surgery within 2 weeks prior to study entry.
Descrição

Therapeutic radiology procedure Bone Marrow Percentage | major surgery

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
UMLS CUI [2]
C0679637
patient received either vinorelbine or imatinib in previous treatment regimens
Descrição

vinorelbine | imatinib

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0078257
UMLS CUI [2]
C0935989
other protocol-defined inclusion/exclusion criteria may apply
Descrição

Eligibility Criteria Study Protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
Voltar ao início da página

Similar models

Eligibility Breast Cancer NCT00372476

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast Advanced Local | Invasive carcinoma of breast metastatic
Item
histologically documented diagnosis of invasive breast cancer that is locally advanced or metastatic
boolean
C0853879 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0853879 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
Chemotherapy Anthracycline Containing
Item
previous anthracycline containing chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
c-kit protein Cell surface | Platelet-Derived Growth Factor Receptor
Item
presence of a certain protein on the cell surface (c-kit (cd117) and /or pdgf-receptor)
boolean
C0072470 (UMLS CUI [1,1])
C0699040 (UMLS CUI [1,2])
C0071253 (UMLS CUI [2])
Tumor tissue sample Available Analysis
Item
preferably tumor samples should be taken within 6 weeks of study entry. most recent primary tumor tissue has to be available for analysis
boolean
C0475358 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0002778 (UMLS CUI [1,3])
Health Status Acceptable ECOG performance status
Item
acceptable health status (eastern cooperative oncology group [ecog]-performance status 0,1, 2 or 3)
boolean
C0018759 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C1520224 (UMLS CUI [1,3])
Exclusion Criteria Second line treatment
Item
exclusion criteria: (for the second-line therapy)
boolean
C0680251 (UMLS CUI [1,1])
C1710038 (UMLS CUI [1,2])
cardiac problem New York Heart Association Classification | Congestive heart failure | Myocardial Infarction | Disease Severe | Disease Uncontrolled | Diabetic - poor control | Chronic Kidney Disease | Communicable Disease Uncontrolled
Item
patient with grade iii/iv cardiac problems (i.e., congestive heart failure, myocardial infarction within 6 months of study) and with severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
boolean
C0262402 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0421258 (UMLS CUI [6])
C1561643 (UMLS CUI [7])
C0009450 (UMLS CUI [8,1])
C0205318 (UMLS CUI [8,2])
Metastatic malignant neoplasm to brain | Chronic liver disease | Hepatitis, Chronic | Liver Cirrhosis chronic | Communicable Disease | HIV Infection
Item
patient has a known brain metastasis, chronic liver disease (i.e., chronic active hepatitis, and cirrhosis) and diagnosis of (hiv) infection.
boolean
C0220650 (UMLS CUI [1])
C0341439 (UMLS CUI [2])
C0019189 (UMLS CUI [3])
C0023890 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0009450 (UMLS CUI [5])
C0019693 (UMLS CUI [6])
Chemotherapy | Rapid disease progression
Item
patient received chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing.
boolean
C0392920 (UMLS CUI [1])
C1834700 (UMLS CUI [2])
Therapeutic radiology procedure Bone Marrow Percentage | major surgery
Item
patient previously received radiotherapy to ≥ 25 % of the bone marrow and had a major surgery within 2 weeks prior to study entry.
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0679637 (UMLS CUI [2])
vinorelbine | imatinib
Item
patient received either vinorelbine or imatinib in previous treatment regimens
boolean
C0078257 (UMLS CUI [1])
C0935989 (UMLS CUI [2])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial