ID

14861

Descrição

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

Link

https://clinicaltrials.gov/show/NCT02370082

Palavras-chave

  1. 02/05/2016 02/05/2016 -
Transferido a

2 de maio de 2016

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0

Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Breast Neoplasm NCT02370082

Eligibility Breast Neoplasm NCT02370082

Inclusion Criteria
Descrição

Inclusion Criteria

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

Lesion of breast Palpable | Requirement Excision

Tipo de dados

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
Descrição

Depth of lesion Surface of skin | Supine Position

Tipo de dados

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
Descrição

Scheduled Excision | Scheduled Breast-Conserving Surgery

Tipo de dados

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
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patient is female
Descrição

Gender

Tipo de dados

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
Descrição

Compliance behavior | Availability of follow-up

Tipo de dados

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
Descrição

Localization of lesion of breast | Coronal

Tipo de dados

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:
Descrição

Study Subject Participation Status

Tipo de dados

boolean

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

Breast Carcinoma Ipsilateral Previous

Tipo de dados

boolean

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

Multicentric Breast Carcinoma

Tipo de dados

boolean

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

Carcinoma breast stage IV

Tipo de dados

boolean

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

Neoadjuvant Therapy Chemotherapy

Tipo de dados

boolean

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

Pregnancy | Breast Feeding

Tipo de dados

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251

Similar models

Eligibility Breast Neoplasm NCT02370082

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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)

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial