ID

35002

Description

TARGIT-C(Consolidation) Prospective Phase IV Study of IORT in Patients With Small Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02290782

Link

https://clinicaltrials.gov/show/NCT02290782

Keywords

Versions (1)
  1. 2/7/19 2/7/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 7, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02290782

English

Eligibility Breast Cancer NCT02290782

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically verified invasive-ductal breast cancer
Description

Invasive Ductal Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C1134719
hormone receptor positive (if known)
Description

Hormone Receptor Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C1514241
ct1 or small ct2 (≤ 3.5 cm) cn0 cm0
Description

TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1]
C0474926
≥ 50 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
compliance
Description

Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
extensive intraductal component (eic)
Description

Extensive intraductal component

Data type

boolean

Alias
UMLS CUI [1]
C1882485
negative hormone receptor status
Description

Hormone Receptor Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C1513916
multifocality /-centricity (mammography, breast ultrasound)
Description

Tumor Multifocal Mammography | Tumor Multicentric Mammography | Tumor Multifocal Breast ultrasound | Tumor Multicentric Breast ultrasound

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0205292
UMLS CUI [1,3]
C0024671
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0439743
UMLS CUI [2,3]
C0024671
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C0205292
UMLS CUI [3,3]
C0080264
UMLS CUI [4,1]
C0027651
UMLS CUI [4,2]
C0439743
UMLS CUI [4,3]
C0080264
lymph vessel invasion (l1)
Description

Lymph vessel Invasion

Data type

boolean

Alias
UMLS CUI [1,1]
C0229889
UMLS CUI [1,2]
C1269955
clinical signs of distant metastases or clinically suspicious lymph nodes
Description

Sign or Symptom Distant metastasis | Lymph nodes Suspicious

Data type

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C1269798
UMLS CUI [2,1]
C0024204
UMLS CUI [2,2]
C0750493
other histology
Description

Histology Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0344441
UMLS CUI [1,2]
C0205394
< 50 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
missing informed consent or non-compliance
Description

Informed Consent Missing | Compliance behavior Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705492
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0332268
bilateral breast cancer at the time of diagnosis
Description

Bilateral breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0281267
known bcra1/2 gene mutations (genetic testing not required)
Description

BRCA1 gene mutation | BRCA2 gene mutation

Data type

boolean

Alias
UMLS CUI [1]
C1511022
UMLS CUI [2]
C1511024
any exclusion criterion in the local centre´s treatment policy
Description

Exclusion Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Breast Cancer NCT02290782

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive Ductal Breast Carcinoma
Item
histologically verified invasive-ductal breast cancer
boolean
C1134719 (UMLS CUI [1])
Hormone Receptor Positive
Item
hormone receptor positive (if known)
boolean
C0019929 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
TNM Breast tumor staging
Item
ct1 or small ct2 (≤ 3.5 cm) cn0 cm0
boolean
C0474926 (UMLS CUI [1])
Age
Item
≥ 50 years of age
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Compliance behavior
Item
compliance
boolean
C1321605 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Extensive intraductal component
Item
extensive intraductal component (eic)
boolean
C1882485 (UMLS CUI [1])
Hormone Receptor Negative
Item
negative hormone receptor status
boolean
C0019929 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Tumor Multifocal Mammography | Tumor Multicentric Mammography | Tumor Multifocal Breast ultrasound | Tumor Multicentric Breast ultrasound
Item
multifocality /-centricity (mammography, breast ultrasound)
boolean
C0027651 (UMLS CUI [1,1])
C0205292 (UMLS CUI [1,2])
C0024671 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0439743 (UMLS CUI [2,2])
C0024671 (UMLS CUI [2,3])
C0027651 (UMLS CUI [3,1])
C0205292 (UMLS CUI [3,2])
C0080264 (UMLS CUI [3,3])
C0027651 (UMLS CUI [4,1])
C0439743 (UMLS CUI [4,2])
C0080264 (UMLS CUI [4,3])
Lymph vessel Invasion
Item
lymph vessel invasion (l1)
boolean
C0229889 (UMLS CUI [1,1])
C1269955 (UMLS CUI [1,2])
Sign or Symptom Distant metastasis | Lymph nodes Suspicious
Item
clinical signs of distant metastases or clinically suspicious lymph nodes
boolean
C3540840 (UMLS CUI [1,1])
C1269798 (UMLS CUI [1,2])
C0024204 (UMLS CUI [2,1])
C0750493 (UMLS CUI [2,2])
Histology Other
Item
other histology
boolean
C0344441 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Age
Item
< 50 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent Missing | Compliance behavior Lacking
Item
missing informed consent or non-compliance
boolean
C0021430 (UMLS CUI [1,1])
C1705492 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Bilateral breast cancer
Item
bilateral breast cancer at the time of diagnosis
boolean
C0281267 (UMLS CUI [1])
BRCA1 gene mutation | BRCA2 gene mutation
Item
known bcra1/2 gene mutations (genetic testing not required)
boolean
C1511022 (UMLS CUI [1])
C1511024 (UMLS CUI [2])
Exclusion Criteria Study Protocol
Item
any exclusion criterion in the local centre´s treatment policy
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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