ID

33753

Description

Chemotherapy for Elderly Patients Diagnosed With Localized HER2 Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02102438

Link

https://clinicaltrials.gov/show/NCT02102438

Keywords

Versions (1)
  1. 12/21/18 12/21/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 21, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Elderly Patients Diagnosed With Breast Cancer NCT02102438

English

Eligibility Elderly Patients Diagnosed With Breast Cancer NCT02102438

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical or pathological stage i- iiia breast adenocarcinoma.
Description

Breast adenocarcinoma TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0474926
her2 overexpression or amplification defined by immunohistochemistry staining of +3 or positive fluorescence in situ hybridization (fish) test.
Description

HER2 Overexpression Immunohistochemistry Staining | HER2 gene amplification Immunohistochemistry Staining | HER2 Overexpression FISH Positive | HER2 gene amplification FISH Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C1514559
UMLS CUI [1,3]
C0021044
UMLS CUI [1,4]
C0487602
UMLS CUI [2,1]
C1512127
UMLS CUI [2,2]
C0021044
UMLS CUI [2,3]
C0487602
UMLS CUI [3,1]
C0069515
UMLS CUI [3,2]
C1514559
UMLS CUI [3,3]
C0162789
UMLS CUI [3,4]
C1514241
UMLS CUI [4,1]
C1512127
UMLS CUI [4,2]
C0162789
UMLS CUI [4,3]
C1514241
age ≥ 65 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
who performance status less than 2; adequate hematologic (granulocyte count ≥ 2 x 109/l, platelet count ≥100 x109/l) and hepatic (transaminases ≤ 1.5 x the upper limit of normal (uln), alkaline phosphatases ≤ 2.5 times uln, and bilirubin ≤ uln) tests; and normal cardiac function (baseline left ventricular ejection fraction at least ≥
Description

WHO performance status scale | Hematologic function | Granulocyte count | Platelet Count measurement | Liver function | Transaminase Assay | Alkaline phosphatase measurement | Serum total bilirubin measurement | Cardiac function | Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C1298650
UMLS CUI [2]
C0221130
UMLS CUI [3]
C0857490
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0232741
UMLS CUI [6]
C0919834
UMLS CUI [7]
C0201850
UMLS CUI [8]
C1278039
UMLS CUI [9]
C0232164
UMLS CUI [10]
C0428772
55%)
Description

ID.5

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
radiologic imaging of metastatic disease.
Description

Neoplasm Metastasis Radiologic Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C3897780
history of cardiac disease contraindicating anthracyclines, uncontrolled essential hypertension or diabetes, stroke or any other comorbidity that could potentially compromise chemotherapy treatment, such as chronic obstructive pulmonary disease.
Description

Heart Disease | Medical contraindication Anthracyclines | Essential Hypertension Uncontrolled | Diabetes Mellitus | Cerebrovascular accident | Comorbidity compromises Chemotherapy | Chronic Obstructive Airway Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0282564
UMLS CUI [3,1]
C0085580
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0011849
UMLS CUI [5]
C0038454
UMLS CUI [6,1]
C0009488
UMLS CUI [6,2]
C2945640
UMLS CUI [6,3]
C0392920
UMLS CUI [7]
C0024117
any previous treatment with anti her2 therapy.
Description

Therapeutic procedure Against HER2

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0069515
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Similar models

Eligibility Elderly Patients Diagnosed With Breast Cancer NCT02102438

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma TNM Breast tumor staging
Item
clinical or pathological stage i- iiia breast adenocarcinoma.
boolean
C0858252 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
HER2 Overexpression Immunohistochemistry Staining | HER2 gene amplification Immunohistochemistry Staining | HER2 Overexpression FISH Positive | HER2 gene amplification FISH Positive
Item
her2 overexpression or amplification defined by immunohistochemistry staining of +3 or positive fluorescence in situ hybridization (fish) test.
boolean
C0069515 (UMLS CUI [1,1])
C1514559 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0487602 (UMLS CUI [1,4])
C1512127 (UMLS CUI [2,1])
C0021044 (UMLS CUI [2,2])
C0487602 (UMLS CUI [2,3])
C0069515 (UMLS CUI [3,1])
C1514559 (UMLS CUI [3,2])
C0162789 (UMLS CUI [3,3])
C1514241 (UMLS CUI [3,4])
C1512127 (UMLS CUI [4,1])
C0162789 (UMLS CUI [4,2])
C1514241 (UMLS CUI [4,3])
Age
Item
age ≥ 65 years old.
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale | Hematologic function | Granulocyte count | Platelet Count measurement | Liver function | Transaminase Assay | Alkaline phosphatase measurement | Serum total bilirubin measurement | Cardiac function | Left ventricular ejection fraction
Item
who performance status less than 2; adequate hematologic (granulocyte count ≥ 2 x 109/l, platelet count ≥100 x109/l) and hepatic (transaminases ≤ 1.5 x the upper limit of normal (uln), alkaline phosphatases ≤ 2.5 times uln, and bilirubin ≤ uln) tests; and normal cardiac function (baseline left ventricular ejection fraction at least ≥
boolean
C1298650 (UMLS CUI [1])
C0221130 (UMLS CUI [2])
C0857490 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0232741 (UMLS CUI [5])
C0919834 (UMLS CUI [6])
C0201850 (UMLS CUI [7])
C1278039 (UMLS CUI [8])
C0232164 (UMLS CUI [9])
C0428772 (UMLS CUI [10])
ID.5
Item
55%)
boolean
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis Radiologic Imaging
Item
radiologic imaging of metastatic disease.
boolean
C0027627 (UMLS CUI [1,1])
C3897780 (UMLS CUI [1,2])
Heart Disease | Medical contraindication Anthracyclines | Essential Hypertension Uncontrolled | Diabetes Mellitus | Cerebrovascular accident | Comorbidity compromises Chemotherapy | Chronic Obstructive Airway Disease
Item
history of cardiac disease contraindicating anthracyclines, uncontrolled essential hypertension or diabetes, stroke or any other comorbidity that could potentially compromise chemotherapy treatment, such as chronic obstructive pulmonary disease.
boolean
C0018799 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0282564 (UMLS CUI [2,2])
C0085580 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0011849 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0009488 (UMLS CUI [6,1])
C2945640 (UMLS CUI [6,2])
C0392920 (UMLS CUI [6,3])
C0024117 (UMLS CUI [7])
Therapeutic procedure Against HER2
Item
any previous treatment with anti her2 therapy.
boolean
C0087111 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0069515 (UMLS CUI [1,3])
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