ID

19593

Beschreibung

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

Stichworte

Versionen (1)
  1. 13.01.17 13.01.17 -
Hochgeladen am

13. Januar 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Breast Cancer NCT00372476

Englisch

Eligibility Breast Cancer NCT00372476

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

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

Datentyp

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
Beschreibung

Chemotherapy Anthracycline Containing

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Tumor tissue sample Available Analysis

Datentyp

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)
Beschreibung

Health Status Acceptable ECOG performance status

Datentyp

boolean

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

Exclusion Criteria Second line treatment

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Chemotherapy | Rapid disease progression

Datentyp

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.
Beschreibung

Therapeutic radiology procedure Bone Marrow Percentage | major surgery

Datentyp

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
Beschreibung

vinorelbine | imatinib

Datentyp

boolean

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

Eligibility Criteria Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Breast Cancer NCT00372476

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video