ID

38246

Beschrijving

Exclusive Intraoperative Radiation Therapy for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01276938

Link

https://clinicaltrials.gov/show/NCT01276938

Trefwoorden

Versies (1)
  1. 02-10-19 02-10-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

2 oktober 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01276938

Engels

Eligibility Breast Neoplasms NCT01276938

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
non lobular epithelial breast carcinoma, excised with standard quadrantectomy
Beschrijving

Breast Carcinoma epithelial | Exception Lobular Carcinoma | Quadrantectomy of breast

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0221908
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0206692
UMLS CUI [3]
C0337354
age ≥ 45 and < 85
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
tumor major diameter ≤ 2.5 cm
Beschrijving

Neoplasm Major Diameter

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C1301886
negative surgical margins (≥ 5 mm)
Beschrijving

Negative Surgical Margin

Datatype

boolean

Alias
UMLS CUI [1]
C1709157
willingness to undergo follow up examinations
Beschrijving

Follow-up Willing

Datatype

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0600109
willingness to undergo imaging examinations (mri, mammograms, ultrasonography)
Beschrijving

Imaging Willing | MRI | Mammography | Ultrasonography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0600109
UMLS CUI [2]
C0024485
UMLS CUI [3]
C0024671
UMLS CUI [4]
C0041618
signed informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
ductal carcinoma in situ or lobular carcinoma
Beschrijving

Ductal carcinoma in situ | Carcinoma, Lobular

Datatype

boolean

Alias
UMLS CUI [1]
C0007124
UMLS CUI [2]
C0206692
extensive intraductal component (greater than 25%) or intraductal carcinoma with microinvasion
Beschrijving

Extensive Intraductal Component Percentage | Ductal Carcinoma In Situ with Microinvasion

Datatype

boolean

Alias
UMLS CUI [1,1]
C1882485
UMLS CUI [1,2]
C0439165
UMLS CUI [2]
C2732473
serious concomitant disease or any disorder or condition (such as psychiatric or addictive disorders) that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
Beschrijving

Comorbidity Serious | Condition Excludes Protocol Compliance | Disease Excludes Protocol Compliance | Mental disorders | Addictive Behavior

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0525058
UMLS CUI [4]
C0004936
UMLS CUI [5]
C0085281
pregnancy or lactation at the time of enrolment proposal (if necessary, during the trial patients must use effective contraceptive device)
Beschrijving

Pregnancy | Breast Feeding | Contraceptive Device as needed

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0009886
UMLS CUI [3,2]
C1555334
collagen vascular disorders
Beschrijving

Collagen-vascular disease

Datatype

boolean

Alias
UMLS CUI [1]
C0262428
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Similar models

Eligibility Breast Neoplasms NCT01276938

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma epithelial | Exception Lobular Carcinoma | Quadrantectomy of breast
Item
non lobular epithelial breast carcinoma, excised with standard quadrantectomy
boolean
C0678222 (UMLS CUI [1,1])
C0221908 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0206692 (UMLS CUI [2,2])
C0337354 (UMLS CUI [3])
Age
Item
age ≥ 45 and < 85
boolean
C0001779 (UMLS CUI [1])
Neoplasm Major Diameter
Item
tumor major diameter ≤ 2.5 cm
boolean
C0027651 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
Negative Surgical Margin
Item
negative surgical margins (≥ 5 mm)
boolean
C1709157 (UMLS CUI [1])
Follow-up Willing
Item
willingness to undergo follow up examinations
boolean
C3274571 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Imaging Willing | MRI | Mammography | Ultrasonography
Item
willingness to undergo imaging examinations (mri, mammograms, ultrasonography)
boolean
C0011923 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0024485 (UMLS CUI [2])
C0024671 (UMLS CUI [3])
C0041618 (UMLS CUI [4])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Ductal carcinoma in situ | Carcinoma, Lobular
Item
ductal carcinoma in situ or lobular carcinoma
boolean
C0007124 (UMLS CUI [1])
C0206692 (UMLS CUI [2])
Extensive Intraductal Component Percentage | Ductal Carcinoma In Situ with Microinvasion
Item
extensive intraductal component (greater than 25%) or intraductal carcinoma with microinvasion
boolean
C1882485 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C2732473 (UMLS CUI [2])
Comorbidity Serious | Condition Excludes Protocol Compliance | Disease Excludes Protocol Compliance | Mental disorders | Addictive Behavior
Item
serious concomitant disease or any disorder or condition (such as psychiatric or addictive disorders) that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4])
C0085281 (UMLS CUI [5])
Pregnancy | Breast Feeding | Contraceptive Device as needed
Item
pregnancy or lactation at the time of enrolment proposal (if necessary, during the trial patients must use effective contraceptive device)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0009886 (UMLS CUI [3,1])
C1555334 (UMLS CUI [3,2])
Collagen-vascular disease
Item
collagen vascular disorders
boolean
C0262428 (UMLS CUI [1])
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