Englisch

Eligibility Breast Neoplasms NCT02307227

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven breast carcinoma evaluated for her 2 status and immune status
Beschreibung

Breast Carcinoma | Evaluation HER2/Neu Status | immune status test

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C1512413
UMLS CUI [3]
C1657725
locally advanced carcinoma (uicc stage ii-iii)
Beschreibung

Locally advanced breast cancer UICC (tumor staging)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C0441914
age < 70 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
measurable lesions
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
ecog performance status 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy > 3 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
adequate bone marrow and hepatic functions
Beschreibung

Bone Marrow function | Liver function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
creatinine clearance > 40 ml/min
Beschreibung

Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0373595
written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
patients must be accessible for treatment and follow up.
Beschreibung

Patient Available Therapeutic procedure | Patient Available Follow-up

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0470187
UMLS CUI [2,3]
C3274571
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy or hormonal treatments
Beschreibung

Chemotherapy | Hormone Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0279025
brain metastases.
Beschreibung

Metastatic malignant neoplasm to brain

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
past or current history of neoplasm other than curatively treated.
Beschreibung

curative treatment Neoplasm

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1273390
UMLS CUI [1,2]
C0027651
concurrent treatment with other experimental drugs.
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
left ventricular ejection fraction (lvef) <50 %
Beschreibung

Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
history of significant neurological or psychiatric disorders.
Beschreibung

nervous system disorder Significant | Mental disorders Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0750502
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Ähnliche Modelle

Eligibility Breast Neoplasms NCT02307227

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Evaluation HER2/Neu Status | immune status test
Item
histologically proven breast carcinoma evaluated for her 2 status and immune status
boolean
C0678222 (UMLS CUI [1])
C1261322 (UMLS CUI [2,1])
C1512413 (UMLS CUI [2,2])
C1657725 (UMLS CUI [3])
Locally advanced breast cancer UICC (tumor staging)
Item
locally advanced carcinoma (uicc stage ii-iii)
boolean
C3495949 (UMLS CUI [1,1])
C0441914 (UMLS CUI [1,2])
Age
Item
age < 70 years
boolean
C0001779 (UMLS CUI [1])
Measurable Disease
Item
measurable lesions
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Bone Marrow function | Liver function
Item
adequate bone marrow and hepatic functions
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
Creatinine clearance measurement
Item
creatinine clearance > 40 ml/min
boolean
C0373595 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Patient Available Therapeutic procedure | Patient Available Follow-up
Item
patients must be accessible for treatment and follow up.
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Hormone Therapy
Item
prior chemotherapy or hormonal treatments
boolean
C0392920 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
Metastatic malignant neoplasm to brain
Item
brain metastases.
boolean
C0220650 (UMLS CUI [1])
curative treatment Neoplasm
Item
past or current history of neoplasm other than curatively treated.
boolean
C1273390 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
Investigational New Drugs
Item
concurrent treatment with other experimental drugs.
boolean
C0013230 (UMLS CUI [1])
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) <50 %
boolean
C0428772 (UMLS CUI [1])
nervous system disorder Significant | Mental disorders Significant
Item
history of significant neurological or psychiatric disorders.
boolean
C0027765 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
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