ID

39123

Description

Sentinel Node Vs Observation After Axillary Ultra-souND; ODM derived from: https://clinicaltrials.gov/show/NCT02167490

Link

https://clinicaltrials.gov/show/NCT02167490

Keywords

Versions (1)
  1. 12/2/19 12/2/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 2, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Early Stage Breast Carcinoma NCT02167490

English

Eligibility Early Stage Breast Carcinoma NCT02167490

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
breast cancer <2 cm, and a clinically negative axilla
Description

Breast Carcinoma Size | Axilla Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0004454
UMLS CUI [2,2]
C1513916
any age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
candidates to receive breast conserving surgery + radiotherapy
Description

Patients Appropriate Breast-Conserving Surgery | Patients Appropriate Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0917927
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C1522449
negative preoperative assessment of the axilla (ultra-sound with or without fnac in case one doubtful node is found)
Description

Axilla Preoperative Negative | Ultrasonography | Fine needle aspiration for cytology | Fine needle aspiration for cytology Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0004454
UMLS CUI [1,2]
C0445204
UMLS CUI [1,3]
C1513916
UMLS CUI [2]
C0041618
UMLS CUI [3]
C2236896
UMLS CUI [4,1]
C2236896
UMLS CUI [4,2]
C0332197
written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients must be accessible for follow-up.
Description

Patients Available Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C3274571
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
synchronous distant metastases
Description

Distant metastasis Synchronous

Data type

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C0439580
previous malignancy
Description

Malignant Neoplasms Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
bilateral breast cancer
Description

Bilateral breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0281267
multicentric or multifocal breast cancer
Description

Multicentric Breast Carcinoma | Multifocal breast carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2986664
UMLS CUI [2]
C2986662
previous primary systemic therapy
Description

Systemic therapy Primary Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0205156
pregnancy or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
pre-operative diagnosis (cytology or histology) of axillary lymph node metastases
Description

AXILLARY LYMPH NODE METASTASIS Preoperative

Data type

boolean

Alias
UMLS CUI [1,1]
C0741344
UMLS CUI [1,2]
C0445204
pre-operative radiological evidence of multiple involved or suspicious nodes
Description

Lymph Node Involvement Multiple Preoperative | Lymph nodes Suspicious Preoperative

Data type

boolean

Alias
UMLS CUI [1,1]
C0806692
UMLS CUI [1,2]
C0439064
UMLS CUI [1,3]
C0445204
UMLS CUI [2,1]
C0024204
UMLS CUI [2,2]
C0750493
UMLS CUI [2,3]
C0445204
patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.
Description

Mental disorders compromise Informed Consent | Addictive Behavior compromises Informed Consent | Disease compromises Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0085281
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0021430
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Similar models

Eligibility Early Stage Breast Carcinoma NCT02167490

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma Size | Axilla Negative
Item
breast cancer <2 cm, and a clinically negative axilla
boolean
C0678222 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0004454 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
Age
Item
any age
boolean
C0001779 (UMLS CUI [1])
Patients Appropriate Breast-Conserving Surgery | Patients Appropriate Therapeutic radiology procedure
Item
candidates to receive breast conserving surgery + radiotherapy
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0917927 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
Axilla Preoperative Negative | Ultrasonography | Fine needle aspiration for cytology | Fine needle aspiration for cytology Absent
Item
negative preoperative assessment of the axilla (ultra-sound with or without fnac in case one doubtful node is found)
boolean
C0004454 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0041618 (UMLS CUI [2])
C2236896 (UMLS CUI [3])
C2236896 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Informed Consent
Item
written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
boolean
C0021430 (UMLS CUI [1])
Patients Available Follow-up
Item
patients must be accessible for follow-up.
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Distant metastasis Synchronous
Item
synchronous distant metastases
boolean
C1269798 (UMLS CUI [1,1])
C0439580 (UMLS CUI [1,2])
Malignant Neoplasms Previous
Item
previous malignancy
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Bilateral breast cancer
Item
bilateral breast cancer
boolean
C0281267 (UMLS CUI [1])
Multicentric Breast Carcinoma | Multifocal breast carcinoma
Item
multicentric or multifocal breast cancer
boolean
C2986664 (UMLS CUI [1])
C2986662 (UMLS CUI [2])
Systemic therapy Primary Previous
Item
previous primary systemic therapy
boolean
C1515119 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
AXILLARY LYMPH NODE METASTASIS Preoperative
Item
pre-operative diagnosis (cytology or histology) of axillary lymph node metastases
boolean
C0741344 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
Lymph Node Involvement Multiple Preoperative | Lymph nodes Suspicious Preoperative
Item
pre-operative radiological evidence of multiple involved or suspicious nodes
boolean
C0806692 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0445204 (UMLS CUI [1,3])
C0024204 (UMLS CUI [2,1])
C0750493 (UMLS CUI [2,2])
C0445204 (UMLS CUI [2,3])
Mental disorders compromise Informed Consent | Addictive Behavior compromises Informed Consent | Disease compromises Informed Consent
Item
patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.
boolean
C0004936 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0085281 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
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