ID

37953

Description

Determination of Predictive Genetic Markers of Toxicity After Hypofractionated Radiotherapy in Breast Cancer Patients Post-Conservative Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT01316328

Link

https://clinicaltrials.gov/show/NCT01316328

Keywords

Versions (1)
  1. 9/2/19 9/2/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 2, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01316328

English

Eligibility Breast Cancer NCT01316328

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 48 years old with a life expectancy of at least 5 years
Description

Age | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0023671
post-menopausal status
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
histologically proven, non lobular, adenocarcinoma of the breast
Description

Breast adenocarcinoma | Exception Lobular adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0858252
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0206692
primary tumours ≤ 3 cm
Description

Primary tumor Size

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0456389
negative surgical margins (≥ 2 mm)
Description

Negative Surgical Margin

Data type

boolean

Alias
UMLS CUI [1]
C1709157
negative sentinel nodes or < 4 positive axillary nodes
Description

Sentinel Lymph Node Negative | Axillary lymph nodes Positive Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1522495
UMLS CUI [1,2]
C1513916
UMLS CUI [2,1]
C0729594
UMLS CUI [2,2]
C1514241
UMLS CUI [2,3]
C1265611
no extra-capsular extension
Description

Absence Extension Extracapsular

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0231448
UMLS CUI [1,3]
C1517049
no previous radiotherapy
Description

Prior radiation therapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
multicentric disease
Description

Disease Multicentric

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0439743
extended intraductal component (eic > 25%)
Description

EIC Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1882485
UMLS CUI [1,2]
C0439165
paget's disease
Description

Paget Disease

Data type

boolean

Alias
UMLS CUI [1]
C1368019
lobular adenocarcinoma
Description

Lobular adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0206692
distant metastases all the above criteria allow to identify patients at low risk of local recurrence.
Description

Distant metastasis

Data type

boolean

Alias
UMLS CUI [1]
C1269798
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Similar models

Eligibility Breast Cancer NCT01316328

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Life Expectancy
Item
age ≥ 48 years old with a life expectancy of at least 5 years
boolean
C0001779 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Postmenopausal state
Item
post-menopausal status
boolean
C0232970 (UMLS CUI [1])
Breast adenocarcinoma | Exception Lobular adenocarcinoma
Item
histologically proven, non lobular, adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0206692 (UMLS CUI [2,2])
Primary tumor Size
Item
primary tumours ≤ 3 cm
boolean
C0677930 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Negative Surgical Margin
Item
negative surgical margins (≥ 2 mm)
boolean
C1709157 (UMLS CUI [1])
Sentinel Lymph Node Negative | Axillary lymph nodes Positive Quantity
Item
negative sentinel nodes or < 4 positive axillary nodes
boolean
C1522495 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0729594 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Absence Extension Extracapsular
Item
no extra-capsular extension
boolean
C0332197 (UMLS CUI [1,1])
C0231448 (UMLS CUI [1,2])
C1517049 (UMLS CUI [1,3])
Prior radiation therapy Absent
Item
no previous radiotherapy
boolean
C0279134 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Disease Multicentric
Item
multicentric disease
boolean
C0012634 (UMLS CUI [1,1])
C0439743 (UMLS CUI [1,2])
EIC Percentage
Item
extended intraductal component (eic > 25%)
boolean
C1882485 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Paget Disease
Item
paget's disease
boolean
C1368019 (UMLS CUI [1])
Lobular adenocarcinoma
Item
lobular adenocarcinoma
boolean
C0206692 (UMLS CUI [1])
Distant metastasis
Item
distant metastases all the above criteria allow to identify patients at low risk of local recurrence.
boolean
C1269798 (UMLS CUI [1])
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