ID

38167

Description

IORT (Intra-operative Radiation Therapy) in Early Stage Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01988870

Link

https://clinicaltrials.gov/show/NCT01988870

Keywords

Versions (1)
  1. 9/23/19 9/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01988870

English

Eligibility Breast Cancer NCT01988870

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women 50 years of age of older
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
patient has elected breast conserving surgical treatment for early-stage breast cancer
Description

Breast-Conserving Surgery Early-Stage Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0917927
UMLS CUI [1,2]
C2986665
patient meets american society for therapeutic radiation oncology (astro) criteria for a "suitable" or "cautionary" patient
Description

Criteria Fulfill | Patient suitable

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C3900053
life expectancy of more than 2 years
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
tumor size 4cm or less
Description

Tumor size

Data type

boolean

Alias
UMLS CUI [1]
C0475440
women of childbearing potential must agree to use adequate contraception
Description

Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
male
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
pregnant or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any contraindication to radiotherapy
Description

Medical contraindication Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1522449
breast cancer that involves skin or chest wall, bilateral breast cancer or history of breast cancer in ipsilateral breast
Description

Breast Carcinoma Involving Skin | Breast Carcinoma Involving Chest wall | Bilateral breast cancer | Medical History Breast Carcinoma | Breast Ipsilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C1123023
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0205076
UMLS CUI [3]
C0281267
UMLS CUI [4,1]
C0262926
UMLS CUI [4,2]
C0678222
UMLS CUI [5,1]
C0006141
UMLS CUI [5,2]
C0441989
patient meets any of the astro criteria for an "unsuitable" patient
Description

Criteria Fulfill | Patient Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
patient requires chemotherapy within two weeks of iort
Description

Patient need for Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0392920
breast implants
Description

Breast implants

Data type

boolean

Alias
UMLS CUI [1]
C0179412
a serious uncontrolled medical disorder
Description

Disease Serious Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
significant history of uncontrolled cardiac disease or cns disease
Description

Heart Disease Uncontrolled | CNS disorder Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007682
UMLS CUI [2,2]
C0205318
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Similar models

Eligibility Breast Cancer NCT01988870

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women 50 years of age of older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast-Conserving Surgery Early-Stage Breast Carcinoma
Item
patient has elected breast conserving surgical treatment for early-stage breast cancer
boolean
C0917927 (UMLS CUI [1,1])
C2986665 (UMLS CUI [1,2])
Criteria Fulfill | Patient suitable
Item
patient meets american society for therapeutic radiation oncology (astro) criteria for a "suitable" or "cautionary" patient
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
Life Expectancy
Item
life expectancy of more than 2 years
boolean
C0023671 (UMLS CUI [1])
Tumor size
Item
tumor size 4cm or less
boolean
C0475440 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential must agree to use adequate contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Gender
Item
male
boolean
C0079399 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical contraindication Therapeutic radiology procedure
Item
any contraindication to radiotherapy
boolean
C1301624 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Breast Carcinoma Involving Skin | Breast Carcinoma Involving Chest wall | Bilateral breast cancer | Medical History Breast Carcinoma | Breast Ipsilateral
Item
breast cancer that involves skin or chest wall, bilateral breast cancer or history of breast cancer in ipsilateral breast
boolean
C0678222 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C1123023 (UMLS CUI [1,3])
C0678222 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0205076 (UMLS CUI [2,3])
C0281267 (UMLS CUI [3])
C0262926 (UMLS CUI [4,1])
C0678222 (UMLS CUI [4,2])
C0006141 (UMLS CUI [5,1])
C0441989 (UMLS CUI [5,2])
Criteria Fulfill | Patient Inappropriate
Item
patient meets any of the astro criteria for an "unsuitable" patient
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
Patient need for Chemotherapy
Item
patient requires chemotherapy within two weeks of iort
boolean
C0686904 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Breast implants
Item
breast implants
boolean
C0179412 (UMLS CUI [1])
Disease Serious Uncontrolled
Item
a serious uncontrolled medical disorder
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Heart Disease Uncontrolled | CNS disorder Uncontrolled
Item
significant history of uncontrolled cardiac disease or cns disease
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007682 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
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