ID

12923

Description

Treatment of T1N0 Invasive Breast Carcinoma by Local Excision Implant; ODM derived from: https://clinicaltrials.gov/show/NCT00977275

Link

https://clinicaltrials.gov/show/NCT00977275

Keywords

  1. 1/6/16 1/6/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 6, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Breast Cancer NCT00977275

Eligibility Breast Cancer NCT00977275

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
low risk of multifocal disease within the breast whose tumor location is favorable for brachytherapy catheter placement
Description

low risk of multifocal disease within the breast whose tumor location is favorable for brachytherapy catheter placement

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0006098
diagnosis of invasive breast carcinoma (biopsy or fine needle aspiration cytology) and be clinical stage t1n0 (primary tumor < 2cm, clinically negative nodes)
Description

diagnosis of invasive breast carcinoma (biopsy or fine needle aspiration cytology) and be clinical stage t1n0 (primary tumor < 2cm, clinically negative nodes)

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C1300072
location of primary tumor is not immediately adjacent to the nipple of chest wall
Description

location of primary tumor is not immediately adjacent to the nipple of chest wall

Data type

boolean

Alias
UMLS CUI [1]
C0872338
no evidence of two or more separate tumors within the breast
Description

no evidence of two or more separate tumors within the breast

Data type

boolean

Alias
UMLS CUI [1]
C0006826
all histologic types and pathologic grades of primary tumor
Description

all histologic types and pathologic grades of primary tumor

Data type

boolean

Alias
UMLS CUI [1]
C0449574
UMLS CUI [2]
C1521733
no extensive intraductal component (substantial intraductal carcinoma away from the primary tumor location)
Description

no extensive intraductal component (substantial intraductal carcinoma away from the primary tumor location)

Data type

boolean

Alias
UMLS CUI [1]
C0872066
no lymphatic or vascular invasion
Description

no lymphatic or vascular invasion

Data type

boolean

Alias
UMLS CUI [1]
C1269955
lymph node staging by sentinel node excision or axillary dissection confirms node negative status (if node positive, implant is used to deliver boost to tumor bed)
Description

lymph node staging

Data type

boolean

Alias
UMLS CUI [1]
C1272457
assessment of final surgical margins should be predominantly negative, but a single small region of focal positivity is allowable as it is for whole breast radiation
Description

assessment of final surgical margins should be predominantly negative, but a single small region of focal positivity is allowable as it is for whole breast radiation

Data type

boolean

Alias
UMLS CUI [1]
C0332649
18 years of age or older
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
tumor is too close to the chest wall to allow placement of catheters
Description

tumor is too close to the chest wall to allow placement of catheters

Data type

boolean

Alias
UMLS CUI [1]
C0872338
contraindications to radiation therapy are present, including a history of scleroderma, systemic lupus or other active connective tissue disease, pregnancy, or prior chest wall radiation
Description

contraindications to radiation therapy are present, including a history of scleroderma, systemic lupus or other active connective tissue disease, pregnancy, or prior chest wall radiation

Data type

boolean

Alias
UMLS CUI [1]
C1522449

Similar models

Eligibility Breast Cancer NCT00977275

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
low risk of multifocal disease within the breast whose tumor location is favorable for brachytherapy catheter placement
Item
low risk of multifocal disease within the breast whose tumor location is favorable for brachytherapy catheter placement
boolean
C0678222 (UMLS CUI [1])
C0006098 (UMLS CUI [2])
diagnosis of invasive breast carcinoma (biopsy or fine needle aspiration cytology) and be clinical stage t1n0 (primary tumor < 2cm, clinically negative nodes)
Item
diagnosis of invasive breast carcinoma (biopsy or fine needle aspiration cytology) and be clinical stage t1n0 (primary tumor < 2cm, clinically negative nodes)
boolean
C0678222 (UMLS CUI [1])
C1300072 (UMLS CUI [2])
location of primary tumor is not immediately adjacent to the nipple of chest wall
Item
location of primary tumor is not immediately adjacent to the nipple of chest wall
boolean
C0872338 (UMLS CUI [1])
no evidence of two or more separate tumors within the breast
Item
no evidence of two or more separate tumors within the breast
boolean
C0006826 (UMLS CUI [1])
all histologic types and pathologic grades of primary tumor
Item
all histologic types and pathologic grades of primary tumor
boolean
C0449574 (UMLS CUI [1])
C1521733 (UMLS CUI [2])
no extensive intraductal component (substantial intraductal carcinoma away from the primary tumor location)
Item
no extensive intraductal component (substantial intraductal carcinoma away from the primary tumor location)
boolean
C0872066 (UMLS CUI [1])
no lymphatic or vascular invasion
Item
no lymphatic or vascular invasion
boolean
C1269955 (UMLS CUI [1])
lymph node staging
Item
lymph node staging by sentinel node excision or axillary dissection confirms node negative status (if node positive, implant is used to deliver boost to tumor bed)
boolean
C1272457 (UMLS CUI [1])
assessment of final surgical margins should be predominantly negative, but a single small region of focal positivity is allowable as it is for whole breast radiation
Item
assessment of final surgical margins should be predominantly negative, but a single small region of focal positivity is allowable as it is for whole breast radiation
boolean
C0332649 (UMLS CUI [1])
age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
tumor is too close to the chest wall to allow placement of catheters
Item
tumor is too close to the chest wall to allow placement of catheters
boolean
C0872338 (UMLS CUI [1])
contraindications to radiation therapy are present, including a history of scleroderma, systemic lupus or other active connective tissue disease, pregnancy, or prior chest wall radiation
Item
contraindications to radiation therapy are present, including a history of scleroderma, systemic lupus or other active connective tissue disease, pregnancy, or prior chest wall radiation
boolean
C1522449 (UMLS CUI [1])

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