ID

22513

Description

Neoadjuvant Chemotherapy of Primary Breast Cancer With Epirubicin/Docetaxel and Carboplatin/Docetaxel; ODM derived from: https://clinicaltrials.gov/show/NCT00527449

Link

https://clinicaltrials.gov/show/NCT00527449

Keywords

  1. 6/6/17 6/6/17 -
Uploaded on

June 6, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Primary Breast Cancer NCT00527449

Eligibility Primary Breast Cancer NCT00527449

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically assured breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
age >= 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
bone marrow function: neutrophils >= 1.5x109/l, platelets >= 100x109/l, hemoglobin >=6.2 mmol/l
Description

Bone Marrow function | Neutrophil count | Platelet Count measurement | Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
sufficient renal and liver function
Description

Renal function | Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
ecog 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or nursing women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
distant metastases
Description

Distant metastasis

Data type

boolean

Alias
UMLS CUI [1]
C1269798
t2-tumour < 3cm and g1
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
existing motoric or sensoric neurotoxicity > grade 2
Description

Neurotoxicity Motor CTCAE Grades | Neurotoxicity Sensory CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0235032
UMLS CUI [1,2]
C0026609
UMLS CUI [1,3]
C1516728
UMLS CUI [2,1]
C0235032
UMLS CUI [2,2]
C0027883
UMLS CUI [2,3]
C1516728
known hypersensitivity against epirubicin or other anthracycline or against carboplatin or other platin derivatives or against docetaxel or against substances in the preparing solutions
Description

Hypersensitivity Epirubicin | Hypersensitivity Anthracyclines | Hypersensitivity Carboplatin | Hypersensitivity Platin Derivative | Hypersensitivity docetaxel | Hypersensitivity Substance Solutions Preparing

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0014582
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0282564
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0079083
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0032207
UMLS CUI [4,3]
C1527240
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0246415
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0439861
UMLS CUI [6,3]
C0037633
UMLS CUI [6,4]
C1521827

Similar models

Eligibility Primary Breast Cancer NCT00527449

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma
Item
histologically assured breast cancer
boolean
C0678222 (UMLS CUI [1])
Age
Item
age >= 18 years
boolean
C0001779 (UMLS CUI [1])
Bone Marrow function | Neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
bone marrow function: neutrophils >= 1.5x109/l, platelets >= 100x109/l, hemoglobin >=6.2 mmol/l
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Renal function | Liver function
Item
sufficient renal and liver function
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
ECOG performance status
Item
ecog 0-2
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Distant metastasis
Item
distant metastases
boolean
C1269798 (UMLS CUI [1])
TNM clinical staging
Item
t2-tumour < 3cm and g1
boolean
C3258246 (UMLS CUI [1])
Neurotoxicity Motor CTCAE Grades | Neurotoxicity Sensory CTCAE Grades
Item
existing motoric or sensoric neurotoxicity > grade 2
boolean
C0235032 (UMLS CUI [1,1])
C0026609 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C0235032 (UMLS CUI [2,1])
C0027883 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
Hypersensitivity Epirubicin | Hypersensitivity Anthracyclines | Hypersensitivity Carboplatin | Hypersensitivity Platin Derivative | Hypersensitivity docetaxel | Hypersensitivity Substance Solutions Preparing
Item
known hypersensitivity against epirubicin or other anthracycline or against carboplatin or other platin derivatives or against docetaxel or against substances in the preparing solutions
boolean
C0020517 (UMLS CUI [1,1])
C0014582 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0282564 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0079083 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0032207 (UMLS CUI [4,2])
C1527240 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0246415 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0439861 (UMLS CUI [6,2])
C0037633 (UMLS CUI [6,3])
C1521827 (UMLS CUI [6,4])

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