ID

38017

Beschrijving

Trial of Neoadjuvant Endostar, Docetaxel and Epirubicin for Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01479036

Link

https://clinicaltrials.gov/show/NCT01479036

Trefwoorden

Versies (1)
  1. 08-09-19 08-09-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

8 september 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01479036

Engels

Eligibility Breast Cancer NCT01479036

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis)
Beschrijving

Invasive carcinoma of breast | Core needle biopsy Breast Carcinoma Diagnosis | Fine needle aspiration Secondary malignant neoplasm of lymph node Diagnosis

Datatype

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2,1]
C1318309
UMLS CUI [2,2]
C0678222
UMLS CUI [2,3]
C0011900
UMLS CUI [3,1]
C1510483
UMLS CUI [3,2]
C0686619
UMLS CUI [3,3]
C0011900
stage ⅱa-ⅲc
Beschrijving

TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1]
C0474926
age 18-70
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status 0-2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
no evidence of distant metastasis
Beschrijving

Distant metastasis Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C0332197
no previous therapy
Beschrijving

Prior Therapy Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
normal hematologic function
Beschrijving

Hematologic function

Datatype

boolean

Alias
UMLS CUI [1]
C0221130
left ventricular ejection fraction greater than 50 percent
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
no abnormality of renal or liver function
Beschrijving

Abnormality Absent Renal function | Abnormality Absent Liver function

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0232804
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0232741
written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
with allergic constitution or possible allergic reflection to drugs to be used in this study
Beschrijving

Constitution allergic | Allergic Reaction Possible Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0683521
UMLS CUI [1,2]
C0700624
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0332149
UMLS CUI [2,3]
C0013230
any concurrent uncontrolled medical or psychiatric disorder
Beschrijving

Comorbidity Uncontrolled | Mental disorder Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205318
history of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease.
Beschrijving

Heart Diseases Severe | Congestive heart failure | Angina, Unstable | Cardiac Arrhythmia Uncontrolled | Myocardial Infarction | Uncontrolled hypertension | Heart valve disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0002965
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205318
UMLS CUI [5]
C0027051
UMLS CUI [6]
C1868885
UMLS CUI [7]
C0018824
history of bleeding diathesis
Beschrijving

Bleeding tendency

Datatype

boolean

Alias
UMLS CUI [1]
C1458140
being pregnant or nursing
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Cancer NCT01479036

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast | Core needle biopsy Breast Carcinoma Diagnosis | Fine needle aspiration Secondary malignant neoplasm of lymph node Diagnosis
Item
histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis)
boolean
C0853879 (UMLS CUI [1])
C1318309 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0011900 (UMLS CUI [2,3])
C1510483 (UMLS CUI [3,1])
C0686619 (UMLS CUI [3,2])
C0011900 (UMLS CUI [3,3])
TNM Breast tumor staging
Item
stage ⅱa-ⅲc
boolean
C0474926 (UMLS CUI [1])
Age
Item
age 18-70
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Distant metastasis Absent
Item
no evidence of distant metastasis
boolean
C1269798 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Prior Therapy Absent
Item
no previous therapy
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Hematologic function
Item
normal hematologic function
boolean
C0221130 (UMLS CUI [1])
Left ventricular ejection fraction
Item
left ventricular ejection fraction greater than 50 percent
boolean
C0428772 (UMLS CUI [1])
Abnormality Absent Renal function | Abnormality Absent Liver function
Item
no abnormality of renal or liver function
boolean
C1704258 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0232804 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0232741 (UMLS CUI [2,3])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Constitution allergic | Allergic Reaction Possible Investigational New Drugs
Item
with allergic constitution or possible allergic reflection to drugs to be used in this study
boolean
C0683521 (UMLS CUI [1,1])
C0700624 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Comorbidity Uncontrolled | Mental disorder Uncontrolled
Item
any concurrent uncontrolled medical or psychiatric disorder
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Heart Diseases Severe | Congestive heart failure | Angina, Unstable | Cardiac Arrhythmia Uncontrolled | Myocardial Infarction | Uncontrolled hypertension | Heart valve disease
Item
history of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease.
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0027051 (UMLS CUI [5])
C1868885 (UMLS CUI [6])
C0018824 (UMLS CUI [7])
Bleeding tendency
Item
history of bleeding diathesis
boolean
C1458140 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
being pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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