ID

38130

Description

Assessment of Ability of Breath Hold for Left-sided Breast Cancer Radiation Therapy to Reduce Side Effects to Heart; ODM derived from: https://clinicaltrials.gov/show/NCT01849614

Link

https://clinicaltrials.gov/show/NCT01849614

Keywords

Versions (1)
  1. 9/20/19 9/20/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01849614

English

Eligibility Breast Cancer NCT01849614

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed an institutional review board (irb)-approved informed consent document for protocol
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
age >= 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed left-sided breast cancer scheduled to undergo curative intent radiation treatment post lumpectomy or mastectomy
Description

Left-Sided Breast Neoplasms | Therapeutic radiology procedure Curative intent Scheduled | Status post Segmental Mastectomy | Status post Mastectomy

Data type

boolean

Alias
UMLS CUI [1]
C4042788
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1276305
UMLS CUI [2,3]
C0205539
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0024885
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0024881
stage 0-iii left-sided breast cancer (including dcis)
Description

Left-Sided Breast Neoplasm TNM Breast tumor staging | DCIS

Data type

boolean

Alias
UMLS CUI [1,1]
C4042788
UMLS CUI [1,2]
C0474926
UMLS CUI [2]
C0007124
spect score of 0 at baseline
Description

SPECT Score

Data type

boolean

Alias
UMLS CUI [1,1]
C0040399
UMLS CUI [1,2]
C0449820
radiation oncologist agrees target volume coverage will not be compromised via use of the dibh technique along with conformal field shaping
Description

Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C3846158
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active cardiac disease, defined as a history of angina, arrhythmias, myocardial infarction, congestive heart failure, or any other cardiac condition, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient
Description

Heart Disease | Angina Pectoris | Cardiac Arrhythmia | Myocardial Infarction | Congestive heart failure | Condition cardiac Study Subject Participation Status At risk

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0003811
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0018802
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C0018787
UMLS CUI [6,3]
C2348568
UMLS CUI [6,4]
C1444641
symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators
Description

Lung disease Symptomatic | Requirement Pharmaceutical Preparations Regular | Bronchodilator Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0205272
UMLS CUI [3]
C0006280
concurrent chemotherapy
Description

Chemotherapy Concurrent

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205420
prior receipt of mediastinal radiation therapy
Description

Irradiation of mediastinum Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C2152905
UMLS CUI [1,2]
C0205156
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
inability to understand and follow breathing instructions for the dibh procedure
Description

Adherence Breathing Instructions Unable | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C1510802
UMLS CUI [1,2]
C0035203
UMLS CUI [1,3]
C1442085
UMLS CUI [1,4]
C1299582
UMLS CUI [2]
C3846158
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Similar models

Eligibility Breast Cancer NCT01849614

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed an institutional review board (irb)-approved informed consent document for protocol
boolean
C0021430 (UMLS CUI [1])
Age
Item
age >= 18 years
boolean
C0001779 (UMLS CUI [1])
Left-Sided Breast Neoplasms | Therapeutic radiology procedure Curative intent Scheduled | Status post Segmental Mastectomy | Status post Mastectomy
Item
histologically confirmed left-sided breast cancer scheduled to undergo curative intent radiation treatment post lumpectomy or mastectomy
boolean
C4042788 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C1276305 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0024885 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0024881 (UMLS CUI [4,2])
Left-Sided Breast Neoplasm TNM Breast tumor staging | DCIS
Item
stage 0-iii left-sided breast cancer (including dcis)
boolean
C4042788 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0007124 (UMLS CUI [2])
SPECT Score
Item
spect score of 0 at baseline
boolean
C0040399 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Other Coding
Item
radiation oncologist agrees target volume coverage will not be compromised via use of the dibh technique along with conformal field shaping
boolean
C3846158 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Heart Disease | Angina Pectoris | Cardiac Arrhythmia | Myocardial Infarction | Congestive heart failure | Condition cardiac Study Subject Participation Status At risk
Item
active cardiac disease, defined as a history of angina, arrhythmias, myocardial infarction, congestive heart failure, or any other cardiac condition, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient
boolean
C0018799 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
C0348080 (UMLS CUI [6,1])
C0018787 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
C1444641 (UMLS CUI [6,4])
Lung disease Symptomatic | Requirement Pharmaceutical Preparations Regular | Bronchodilator Agents
Item
symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators
boolean
C0024115 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0205272 (UMLS CUI [2,3])
C0006280 (UMLS CUI [3])
Chemotherapy Concurrent
Item
concurrent chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
Irradiation of mediastinum Previous
Item
prior receipt of mediastinal radiation therapy
boolean
C2152905 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Adherence Breathing Instructions Unable | Other Coding
Item
inability to understand and follow breathing instructions for the dibh procedure
boolean
C1510802 (UMLS CUI [1,1])
C0035203 (UMLS CUI [1,2])
C1442085 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C3846158 (UMLS CUI [2])
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