ID

14861

Description

SAVI SCOUT Clinical Evaluation Study; ODM derived from: https://clinicaltrials.gov/show/NCT02370082

Link

https://clinicaltrials.gov/show/NCT02370082

Keywords

  1. 5/2/16 5/2/16 -
Uploaded on

May 2, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Neoplasm NCT02370082

Eligibility Breast Neoplasm NCT02370082

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
• patient has a non-palpable breast lesion that requires excision
Description

Lesion of breast Palpable | Requirement Excision

Data type

boolean

Alias
UMLS CUI [1,1]
C0567489
UMLS CUI [1,2]
C0522499
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0728940
lesion depth ≤ 3 cm from the skin surface in the supine position
Description

Depth of lesion Surface of skin | Supine Position

Data type

boolean

Alias
UMLS CUI [1,1]
C1827571
UMLS CUI [1,2]
C1180212
UMLS CUI [2]
C0038846
patient is scheduled for excision or bct at a participating institution
Description

Scheduled Excision | Scheduled Breast-Conserving Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0205539
UMLS CUI [1,2]
C0728940
UMLS CUI [2,1]
C0205539
UMLS CUI [2,2]
C0917927
patient is between the ages of 18 and 90 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient is female
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
patient is willing and able to comply with all study procedures and be available to follow-up for the duration of the study
Description

Compliance behavior | Availability of follow-up

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C1522577
for lesions requiring multiple reflectors for localization, they must allow for reflectors to be placed ≥ 1cm from one another relative to the coronal plane subject exclusion criteria
Description

Localization of lesion of breast | Coronal

Data type

boolean

Alias
UMLS CUI [1]
C0842739
UMLS CUI [2]
C0205123
an individual who meets any of the following criteria will be excluded from participation in this study:
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
patient had a previous ipsilateral breast cancer
Description

Breast Carcinoma Ipsilateral Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0441989
UMLS CUI [1,3]
C0205156
patient has multicentric breast cancer
Description

Multicentric Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2986664
patient has stage iv breast cancer
Description

Carcinoma breast stage IV

Data type

boolean

Alias
UMLS CUI [1]
C0278488
patient has been treated with neoadjuvant chemotherapy
Description

Neoadjuvant Therapy Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
patient is pregnant or lactating
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251

Similar models

Eligibility Breast Neoplasm NCT02370082

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Lesion of breast Palpable | Requirement Excision
Item
• patient has a non-palpable breast lesion that requires excision
boolean
C0567489 (UMLS CUI [1,1])
C0522499 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0728940 (UMLS CUI [2,2])
Depth of lesion Surface of skin | Supine Position
Item
lesion depth ≤ 3 cm from the skin surface in the supine position
boolean
C1827571 (UMLS CUI [1,1])
C1180212 (UMLS CUI [1,2])
C0038846 (UMLS CUI [2])
Scheduled Excision | Scheduled Breast-Conserving Surgery
Item
patient is scheduled for excision or bct at a participating institution
boolean
C0205539 (UMLS CUI [1,1])
C0728940 (UMLS CUI [1,2])
C0205539 (UMLS CUI [2,1])
C0917927 (UMLS CUI [2,2])
Age
Item
patient is between the ages of 18 and 90 years
boolean
C0001779 (UMLS CUI [1])
Gender
Item
patient is female
boolean
C0079399 (UMLS CUI [1])
Compliance behavior | Availability of follow-up
Item
patient is willing and able to comply with all study procedures and be available to follow-up for the duration of the study
boolean
C1321605 (UMLS CUI [1])
C0470187 (UMLS CUI [2,1])
C1522577 (UMLS CUI [2,2])
Localization of lesion of breast | Coronal
Item
for lesions requiring multiple reflectors for localization, they must allow for reflectors to be placed ≥ 1cm from one another relative to the coronal plane subject exclusion criteria
boolean
C0842739 (UMLS CUI [1])
C0205123 (UMLS CUI [2])
Study Subject Participation Status
Item
an individual who meets any of the following criteria will be excluded from participation in this study:
boolean
C2348568 (UMLS CUI [1])
Breast Carcinoma Ipsilateral Previous
Item
patient had a previous ipsilateral breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Multicentric Breast Carcinoma
Item
patient has multicentric breast cancer
boolean
C2986664 (UMLS CUI [1])
Carcinoma breast stage IV
Item
patient has stage iv breast cancer
boolean
C0278488 (UMLS CUI [1])
Neoadjuvant Therapy Chemotherapy
Item
patient has been treated with neoadjuvant chemotherapy
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
patient is pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)

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