ID

12963

Beschrijving

Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00193050

Link

https://clinicaltrials.gov/show/NCT00193050

Trefwoorden

  1. 07-01-16 07-01-16 -
Geüploaded op

7 januari 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00193050

Eligibility Breast Cancer NCT00193050

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
adenocarcinoma of the breast confirmed by biopsy
Beschrijving

biopsy adenocarcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0858252
female patients >18 years of age
Beschrijving

age, gender

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
normal cardiac function
Beschrijving

cardiac function

Datatype

boolean

Alias
UMLS CUI [1]
C0232164
ability to perform activities of daily living with minimal assistance
Beschrijving

performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1518965
chemotherapy naïve or have received prior chemotherapy > 5 years ago
Beschrijving

chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
adequate bone marrow, liver and kidney function
Beschrijving

bone marrow, liver and kidney function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0005953
UMLS CUI [3]
C0232804
be informed of the investigational nature of this study
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
sign an informed consent form
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
sentinel lymph node and/or axillary dissection prior to enrollment
Beschrijving

sentinel lymph node, axillary dissection

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024203
UMLS CUI [1,2]
C1522495
UMLS CUI [2]
C0193867
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
life expectancy of < than 6 months
Beschrijving

life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
history of significant heart disease
Beschrijving

heart disease

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
prior chemotherapy or hormonal therapy
Beschrijving

chemotherapy, hormone therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0279025
concurrent trastuzumab therapy
Beschrijving

trastuzumab

Datatype

boolean

Alias
UMLS CUI [1]
C0338204
history of significant psychiatric disorders
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0004936
history of active uncontrolled infection
Beschrijving

infection

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Beschrijving

additional inclusion/exclusion criteria

Datatype

boolean

Similar models

Eligibility Breast Cancer NCT00193050

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
biopsy adenocarcinoma
Item
adenocarcinoma of the breast confirmed by biopsy
boolean
C0005558 (UMLS CUI [1,1])
C0858252 (UMLS CUI [1,2])
age, gender
Item
female patients >18 years of age
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
cardiac function
Item
normal cardiac function
boolean
C0232164 (UMLS CUI [1])
performance status
Item
ability to perform activities of daily living with minimal assistance
boolean
C1518965 (UMLS CUI [1])
chemotherapy
Item
chemotherapy naïve or have received prior chemotherapy > 5 years ago
boolean
C0392920 (UMLS CUI [1])
bone marrow, liver and kidney function
Item
adequate bone marrow, liver and kidney function
boolean
C0232741 (UMLS CUI [1])
C0005953 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
informed consent
Item
be informed of the investigational nature of this study
boolean
C0021430 (UMLS CUI [1])
informed consent
Item
sign an informed consent form
boolean
C0021430 (UMLS CUI [1])
sentinel lymph node, axillary dissection
Item
sentinel lymph node and/or axillary dissection prior to enrollment
boolean
C0024203 (UMLS CUI [1,1])
C1522495 (UMLS CUI [1,2])
C0193867 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
life expectancy
Item
life expectancy of < than 6 months
boolean
C0023671 (UMLS CUI [1])
heart disease
Item
history of significant heart disease
boolean
C0018799 (UMLS CUI [1])
chemotherapy, hormone therapy
Item
prior chemotherapy or hormonal therapy
boolean
C0392920 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
trastuzumab
Item
concurrent trastuzumab therapy
boolean
C0338204 (UMLS CUI [1])
comorbidity
Item
history of significant psychiatric disorders
boolean
C0009488 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
infection
Item
history of active uncontrolled infection
boolean
C0009450 (UMLS CUI [1])
additional inclusion/exclusion criteria
Item
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
boolean

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