ID

40465

Description

Single Fraction Intraoperative Radiotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT01688388

Link

https://clinicaltrials.gov/show/NCT01688388

Keywords

Versions (1)
  1. 4/23/20 4/23/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 23, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Invasive Ductal and Invasive Lobular Breast Carcinoma NCT01688388

English

Eligibility Invasive Ductal and Invasive Lobular Breast Carcinoma NCT01688388

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological proven invasive breast carcinoma ductal, lobular and/or ductal carcinoma in situ
Description

Invasive Ductal Breast Carcinoma | Invasive Lobular Breast Carcinoma | Ductal carcinoma in situ

Data type

boolean

Alias
UMLS CUI [1]
C1134719
UMLS CUI [2]
C0279565
UMLS CUI [3]
C0007124
age > 40 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky performance status > 70%
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
tumor. single discrete tumor or focal microcalcifications that can be imaged on a specimen radiograph or multifocal disease within the same quadrant with a maximum dimension of equal to or less than 2.5 cm
Description

Single tumor discrete | Microcalcification Focal Specimen mammography | Disease Multifocal Dimension Maximum

Data type

boolean

Alias
UMLS CUI [1,1]
C1298180
UMLS CUI [1,2]
C0443299
UMLS CUI [2,1]
C0520594
UMLS CUI [2,2]
C0205234
UMLS CUI [2,3]
C0203031
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205292
UMLS CUI [3,3]
C0439534
UMLS CUI [3,4]
C0806909
nodal status: preoperatively n0
Description

Lymph nodal status Preoperative TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0449927
UMLS CUI [1,2]
C0445204
UMLS CUI [1,3]
C0474926
clear surgical margins: r0
Description

Negative Surgical Margin TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C1709157
UMLS CUI [1,2]
C0474926
all grades g1 - g3
Description

Grade TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0441800
UMLS CUI [1,2]
C0474926
any hormonal receptor and her-2 status
Description

Hormone Receptor Status Any | HER2 Status Any

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C1552551
UMLS CUI [2,1]
C1512413
UMLS CUI [2,2]
C1552551
informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
gender: male
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
tumor size: more than 2.5 cm
Description

Tumor size

Data type

boolean

Alias
UMLS CUI [1]
C0475440
nodal status greater than or equal to n1 pathologically
Description

Lymph nodal status TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0449927
UMLS CUI [1,2]
C0474926
multicentricity
Description

Multicentric

Data type

boolean

Alias
UMLS CUI [1]
C0439743
previous radiotherapy to the involved breast
Description

Prior radiation therapy Breast Involved

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C1314939
karnofsky index < 70%
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
mixed connective tissue diseases e.g. rheumatoid poly arthritis, thromboangitis obliterans, systemic lupus
Description

Mixed Connective Tissue Disease | Polyarthritis rheumatoid | Thromboangiitis Obliterans | Lupus Erythematosus, Systemic

Data type

boolean

Alias
UMLS CUI [1]
C0026272
UMLS CUI [2]
C1405320
UMLS CUI [3]
C0040021
UMLS CUI [4]
C0024141
distant metastases
Description

Distant metastasis

Data type

boolean

Alias
UMLS CUI [1]
C1269798
pregnancy in woman of child bearing age
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
unable to provide written consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Invasive Ductal and Invasive Lobular Breast Carcinoma NCT01688388

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive Ductal Breast Carcinoma | Invasive Lobular Breast Carcinoma | Ductal carcinoma in situ
Item
histological proven invasive breast carcinoma ductal, lobular and/or ductal carcinoma in situ
boolean
C1134719 (UMLS CUI [1])
C0279565 (UMLS CUI [2])
C0007124 (UMLS CUI [3])
Age
Item
age > 40 years
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance status > 70%
boolean
C0206065 (UMLS CUI [1])
Single tumor discrete | Microcalcification Focal Specimen mammography | Disease Multifocal Dimension Maximum
Item
tumor. single discrete tumor or focal microcalcifications that can be imaged on a specimen radiograph or multifocal disease within the same quadrant with a maximum dimension of equal to or less than 2.5 cm
boolean
C1298180 (UMLS CUI [1,1])
C0443299 (UMLS CUI [1,2])
C0520594 (UMLS CUI [2,1])
C0205234 (UMLS CUI [2,2])
C0203031 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0205292 (UMLS CUI [3,2])
C0439534 (UMLS CUI [3,3])
C0806909 (UMLS CUI [3,4])
Lymph nodal status Preoperative TNM Breast tumor staging
Item
nodal status: preoperatively n0
boolean
C0449927 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
Negative Surgical Margin TNM Breast tumor staging
Item
clear surgical margins: r0
boolean
C1709157 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Grade TNM Breast tumor staging
Item
all grades g1 - g3
boolean
C0441800 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Hormone Receptor Status Any | HER2 Status Any
Item
any hormonal receptor and her-2 status
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C1512413 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Gender
Item
gender: male
boolean
C0079399 (UMLS CUI [1])
Tumor size
Item
tumor size: more than 2.5 cm
boolean
C0475440 (UMLS CUI [1])
Lymph nodal status TNM Breast tumor staging
Item
nodal status greater than or equal to n1 pathologically
boolean
C0449927 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Multicentric
Item
multicentricity
boolean
C0439743 (UMLS CUI [1])
Prior radiation therapy Breast Involved
Item
previous radiotherapy to the involved breast
boolean
C0279134 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
Karnofsky Performance Status
Item
karnofsky index < 70%
boolean
C0206065 (UMLS CUI [1])
Mixed Connective Tissue Disease | Polyarthritis rheumatoid | Thromboangiitis Obliterans | Lupus Erythematosus, Systemic
Item
mixed connective tissue diseases e.g. rheumatoid poly arthritis, thromboangitis obliterans, systemic lupus
boolean
C0026272 (UMLS CUI [1])
C1405320 (UMLS CUI [2])
C0040021 (UMLS CUI [3])
C0024141 (UMLS CUI [4])
Distant metastasis
Item
distant metastases
boolean
C1269798 (UMLS CUI [1])
Pregnancy
Item
pregnancy in woman of child bearing age
boolean
C0032961 (UMLS CUI [1])
Informed Consent Unable
Item
unable to provide written consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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