ID

34961

Description

A Study to See Whether Breath-Hold Techniques During Radiation Radiation Treatment Are Effective in Helping to Improve Sparing of the Heart; ODM derived from: https://clinicaltrials.gov/show/NCT02052102

Link

https://clinicaltrials.gov/show/NCT02052102

Keywords

Versions (1)
  1. 2/5/19 2/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 5, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02052102

English

Eligibility Breast Cancer NCT02052102

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients with pathologically confirmed left-sided node positive breast cancer eligible for adjuvant breast/chest wall and regional nodal radiotherapy (including imn)
Description

Gender | Node-positive breast cancer Left sided | Eligibility Radiotherapy to breast Adjuvant | Eligibility Radiotherapy to chest wall Adjuvant | Eligibility Radiotherapy to lymph nodes regional | Radiotherapy to lymph nodes Including Internal Mammary Lymph Node

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3160887
UMLS CUI [2,2]
C0443246
UMLS CUI [3,1]
C1548635
UMLS CUI [3,2]
C0948310
UMLS CUI [3,3]
C1522673
UMLS CUI [4,1]
C1548635
UMLS CUI [4,2]
C1998066
UMLS CUI [4,3]
C1522673
UMLS CUI [5,1]
C1548635
UMLS CUI [5,2]
C1504399
UMLS CUI [5,3]
C0205147
UMLS CUI [6,1]
C1504399
UMLS CUI [6,2]
C0332257
UMLS CUI [6,3]
C0229755
female patients with age between 40 and 70 years
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
karnofsky performance score ≥ 70
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
ability to hold breath for at least 15 - 20 seconds (to participate in dibh study arms)
Description

Ability Stop Breath Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C2746065
UMLS CUI [1,3]
C0225386
UMLS CUI [1,4]
C0449238
life expectancy > 10 years
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
< 1.0 cm involvement of the left ventricle in the free breathing scanning
Description

Left ventricle Involvement Size | Breathing Scanning

Data type

boolean

Alias
UMLS CUI [1,1]
C0225897
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0456389
UMLS CUI [2,1]
C0035203
UMLS CUI [2,2]
C0441633
history of uncontrolled hypertension or myocardial infarction, heart failure, cardiomyopathy, or baseline lvef < 50% or severe copd
Description

Uncontrolled hypertension | Myocardial Infarction | Heart failure | Cardiomyopathy | Left ventricular ejection fraction | Severe chronic obstructive pulmonary disease

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0018801
UMLS CUI [4]
C0878544
UMLS CUI [5]
C0428772
UMLS CUI [6]
C0730607
anti-hypertensive therapy with ace-inhibitors, angiotensin receptor blockers or beta blockers
Description

Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists

Data type

boolean

Alias
UMLS CUI [1]
C0003015
UMLS CUI [2]
C0521942
UMLS CUI [3]
C0304516
patient requiring boost
Description

Patient need for Boost radiation therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C2919491
stage iv disease or dcis
Description

Disease TNM Breast tumor staging | DCIS

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0474926
UMLS CUI [2]
C0007124
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Similar models

Eligibility Breast Cancer NCT02052102

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Node-positive breast cancer Left sided | Eligibility Radiotherapy to breast Adjuvant | Eligibility Radiotherapy to chest wall Adjuvant | Eligibility Radiotherapy to lymph nodes regional | Radiotherapy to lymph nodes Including Internal Mammary Lymph Node
Item
female patients with pathologically confirmed left-sided node positive breast cancer eligible for adjuvant breast/chest wall and regional nodal radiotherapy (including imn)
boolean
C0079399 (UMLS CUI [1])
C3160887 (UMLS CUI [2,1])
C0443246 (UMLS CUI [2,2])
C1548635 (UMLS CUI [3,1])
C0948310 (UMLS CUI [3,2])
C1522673 (UMLS CUI [3,3])
C1548635 (UMLS CUI [4,1])
C1998066 (UMLS CUI [4,2])
C1522673 (UMLS CUI [4,3])
C1548635 (UMLS CUI [5,1])
C1504399 (UMLS CUI [5,2])
C0205147 (UMLS CUI [5,3])
C1504399 (UMLS CUI [6,1])
C0332257 (UMLS CUI [6,2])
C0229755 (UMLS CUI [6,3])
Gender | Age
Item
female patients with age between 40 and 70 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Karnofsky Performance Status
Item
karnofsky performance score ≥ 70
boolean
C0206065 (UMLS CUI [1])
Ability Stop Breath Duration
Item
ability to hold breath for at least 15 - 20 seconds (to participate in dibh study arms)
boolean
C0085732 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0225386 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
Life Expectancy
Item
life expectancy > 10 years
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Left ventricle Involvement Size | Breathing Scanning
Item
< 1.0 cm involvement of the left ventricle in the free breathing scanning
boolean
C0225897 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C0035203 (UMLS CUI [2,1])
C0441633 (UMLS CUI [2,2])
Uncontrolled hypertension | Myocardial Infarction | Heart failure | Cardiomyopathy | Left ventricular ejection fraction | Severe chronic obstructive pulmonary disease
Item
history of uncontrolled hypertension or myocardial infarction, heart failure, cardiomyopathy, or baseline lvef < 50% or severe copd
boolean
C1868885 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
C0878544 (UMLS CUI [4])
C0428772 (UMLS CUI [5])
C0730607 (UMLS CUI [6])
Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists
Item
anti-hypertensive therapy with ace-inhibitors, angiotensin receptor blockers or beta blockers
boolean
C0003015 (UMLS CUI [1])
C0521942 (UMLS CUI [2])
C0304516 (UMLS CUI [3])
Patient need for Boost radiation therapy
Item
patient requiring boost
boolean
C0686904 (UMLS CUI [1,1])
C2919491 (UMLS CUI [1,2])
Disease TNM Breast tumor staging | DCIS
Item
stage iv disease or dcis
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0007124 (UMLS CUI [2])
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