ID

38118

Description

Pilot Indocyanine Green™ Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01771666

Link

https://clinicaltrials.gov/show/NCT01771666

Keywords

Versions (1)
  1. 9/18/19 9/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01771666

English

Eligibility Breast Cancer NCT01771666

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ability to understand and the willingness to sign a written informed consent document.
Description

Comprehension Informed Consent | Consent sign Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0021430
UMLS CUI [2,1]
C0742766
UMLS CUI [2,2]
C0600109
signed written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
women undergoing sentinel lymph node biopsy.
Description

Gender | Sentinel Lymph Node Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0796693
women with breast cancer with known or suspected lymph node involvement.
Description

Gender | Breast Carcinoma | Lymph Node Involvement | Lymph Node Involvement Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0678222
UMLS CUI [3]
C0806692
UMLS CUI [4,1]
C0806692
UMLS CUI [4,2]
C0750491
women undergoing sentinel node identification and completion axillary lymph node dissection.
Description

Gender | Sentinel Lymph Node Identification | Excision of axillary lymph nodes Completion

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C1522495
UMLS CUI [2,2]
C0205396
UMLS CUI [3,1]
C0193867
UMLS CUI [3,2]
C0205197
women of 18 years of age or older.
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
eastern cooperative oncology group (ecog) or karnofsky performance status 0,1,2.
Description

ECOG performance status | Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
complete blood count (cbc) and basic metabolic panel within 6 months
Description

Complete Blood Count | Basic metabolic panel

Data type

boolean

Alias
UMLS CUI [1]
C0009555
UMLS CUI [2]
C2237045
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of liver or kidney failure will not be eligible.
Description

Liver Failure | Kidney Failure

Data type

boolean

Alias
UMLS CUI [1]
C0085605
UMLS CUI [2]
C0035078
allergies to iodine containing products will not be eligible.
Description

Iodine allergy

Data type

boolean

Alias
UMLS CUI [1]
C0571818
women who are pregnant will not be eligible.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
Description

Mental disorders Protocol Compliance Excluded | Addictive Behavior Protocol Compliance Excluded | Condition Protocol Compliance Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0085281
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0332196
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0525058
UMLS CUI [3,3]
C0332196
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Similar models

Eligibility Breast Cancer NCT01771666

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Comprehension Informed Consent | Consent sign Willing
Item
ability to understand and the willingness to sign a written informed consent document.
boolean
C0162340 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0742766 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Informed Consent
Item
signed written informed consent.
boolean
C0021430 (UMLS CUI [1])
Gender | Sentinel Lymph Node Biopsy
Item
women undergoing sentinel lymph node biopsy.
boolean
C0079399 (UMLS CUI [1])
C0796693 (UMLS CUI [2])
Gender | Breast Carcinoma | Lymph Node Involvement | Lymph Node Involvement Suspected
Item
women with breast cancer with known or suspected lymph node involvement.
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C0806692 (UMLS CUI [3])
C0806692 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Gender | Sentinel Lymph Node Identification | Excision of axillary lymph nodes Completion
Item
women undergoing sentinel node identification and completion axillary lymph node dissection.
boolean
C0079399 (UMLS CUI [1])
C1522495 (UMLS CUI [2,1])
C0205396 (UMLS CUI [2,2])
C0193867 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
Gender | Age
Item
women of 18 years of age or older.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
ECOG performance status | Karnofsky Performance Status
Item
eastern cooperative oncology group (ecog) or karnofsky performance status 0,1,2.
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Complete Blood Count | Basic metabolic panel
Item
complete blood count (cbc) and basic metabolic panel within 6 months
boolean
C0009555 (UMLS CUI [1])
C2237045 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Liver Failure | Kidney Failure
Item
history of liver or kidney failure will not be eligible.
boolean
C0085605 (UMLS CUI [1])
C0035078 (UMLS CUI [2])
Iodine allergy
Item
allergies to iodine containing products will not be eligible.
boolean
C0571818 (UMLS CUI [1])
Pregnancy
Item
women who are pregnant will not be eligible.
boolean
C0032961 (UMLS CUI [1])
Mental disorders Protocol Compliance Excluded | Addictive Behavior Protocol Compliance Excluded | Condition Protocol Compliance Excluded
Item
psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
boolean
C0004936 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0085281 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
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