ID

14861

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT02370082

Stichworte

  1. 02.05.16 02.05.16 -
Hochgeladen am

2. Mai 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Breast Neoplasm NCT02370082

Eligibility Breast Neoplasm NCT02370082

Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Lesion of breast Palpable | Requirement Excision

Datentyp

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
Beschreibung

Depth of lesion Surface of skin | Supine Position

Datentyp

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
Beschreibung

Scheduled Excision | Scheduled Breast-Conserving Surgery

Datentyp

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
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patient is female
Beschreibung

Gender

Datentyp

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
Beschreibung

Compliance behavior | Availability of follow-up

Datentyp

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
Beschreibung

Localization of lesion of breast | Coronal

Datentyp

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:
Beschreibung

Study Subject Participation Status

Datentyp

boolean

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

Breast Carcinoma Ipsilateral Previous

Datentyp

boolean

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

Multicentric Breast Carcinoma

Datentyp

boolean

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

Carcinoma breast stage IV

Datentyp

boolean

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

Neoadjuvant Therapy Chemotherapy

Datentyp

boolean

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

Pregnancy | Breast Feeding

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251

Ähnliche Modelle

Eligibility Breast Neoplasm NCT02370082

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video