ID

41198

Description

Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients.; ODM derived from: https://clinicaltrials.gov/show/NCT01276054

Link

https://clinicaltrials.gov/show/NCT01276054

Keywords

Versions (1)
  1. 7/11/20 7/11/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 11, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphedema NCT01276054

English

Eligibility Lymphedema NCT01276054

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphedema NCT01276054
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
stage 0, i, and ii breast cancer
Description

Breast Carcinoma TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
not pregnant or breastfeeding
Description

Pregnancy Absent | Breast Feeding Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
breast cancer or prophylactic mastectomy requiring axillary nodal staging
Description

Breast Carcinoma | Prophylactic Mastectomy | Requirement Axillary lymph nodes TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C2191320
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0729594
UMLS CUI [3,3]
C3258246
ability to read and/or comprehend consent form and questionnaires
Description

Able to read Informed Consent | Comprehension Informed Consent | Able to read Questionnaires | Comprehension Questionnaires

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0021430
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0021430
UMLS CUI [3,1]
C0586740
UMLS CUI [3,2]
C0034394
UMLS CUI [4,1]
C0233733
UMLS CUI [4,2]
C0034394
ability to follow-up per protocol
Description

Availability Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C3274571
unilateral axillary staging
Description

Axillary lymph node level (tumor staging) Unilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0441924
UMLS CUI [1,2]
C0205092
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
stage 3
Description

TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1]
C0474926
previous axillary lymph node dissection
Description

Excision of axillary lymph nodes

Data type

boolean

Alias
UMLS CUI [1]
C0193867
neoadjuvant chemotherapy or hormonal therapy exceeding greater than 30 days duration
Description

Neoadjuvant Chemotherapy Duration | Hormone Therapy Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0449238
allergy to blue dyes or iodine; note: a non-blue dye or non-iodine-containing dye may be used in these patients
Description

Hypersensitivity Blue dye | Iodine allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1509231
UMLS CUI [2]
C0571818
patients with implanted medical devices such as a pacemaker may undergo perometry, but not bis (bioelectrical impedance spectroscopy)
Description

Implants | Artificial cardiac pacemaker

Data type

boolean

Alias
UMLS CUI [1]
C0021102
UMLS CUI [2]
C0030163
previous diagnosis of le (lymphedema) of either extremity
Description

Lymphedema Extremity

Data type

boolean

Alias
UMLS CUI [1,1]
C0024236
UMLS CUI [1,2]
C0015385
bilateral axillary staging
Description

Axillary lymph node level (tumor staging) Bilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0441924
UMLS CUI [1,2]
C0238767
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Similar models

Eligibility Lymphedema NCT01276054

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Lymphedema NCT01276054
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma TNM Breast tumor staging
Item
stage 0, i, and ii breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Breast Carcinoma | Prophylactic Mastectomy | Requirement Axillary lymph nodes TNM clinical staging
Item
breast cancer or prophylactic mastectomy requiring axillary nodal staging
boolean
C0678222 (UMLS CUI [1])
C2191320 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0729594 (UMLS CUI [3,2])
C3258246 (UMLS CUI [3,3])
Able to read Informed Consent | Comprehension Informed Consent | Able to read Questionnaires | Comprehension Questionnaires
Item
ability to read and/or comprehend consent form and questionnaires
boolean
C0586740 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0233733 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
C0586740 (UMLS CUI [3,1])
C0034394 (UMLS CUI [3,2])
C0233733 (UMLS CUI [4,1])
C0034394 (UMLS CUI [4,2])
Availability Follow-up
Item
ability to follow-up per protocol
boolean
C0470187 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
Axillary lymph node level (tumor staging) Unilateral
Item
unilateral axillary staging
boolean
C0441924 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
TNM Breast tumor staging
Item
stage 3
boolean
C0474926 (UMLS CUI [1])
Excision of axillary lymph nodes
Item
previous axillary lymph node dissection
boolean
C0193867 (UMLS CUI [1])
Neoadjuvant Chemotherapy Duration | Hormone Therapy Duration
Item
neoadjuvant chemotherapy or hormonal therapy exceeding greater than 30 days duration
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0279025 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Hypersensitivity Blue dye | Iodine allergy
Item
allergy to blue dyes or iodine; note: a non-blue dye or non-iodine-containing dye may be used in these patients
boolean
C0020517 (UMLS CUI [1,1])
C1509231 (UMLS CUI [1,2])
C0571818 (UMLS CUI [2])
Implants | Artificial cardiac pacemaker
Item
patients with implanted medical devices such as a pacemaker may undergo perometry, but not bis (bioelectrical impedance spectroscopy)
boolean
C0021102 (UMLS CUI [1])
C0030163 (UMLS CUI [2])
Lymphedema Extremity
Item
previous diagnosis of le (lymphedema) of either extremity
boolean
C0024236 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
Axillary lymph node level (tumor staging) Bilateral
Item
bilateral axillary staging
boolean
C0441924 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
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