ID

35070

Description

Immunotherapy for the Treatment of Breast Cancer Related Upper Extremity Lymphedema (BCRL); ODM derived from: https://clinicaltrials.gov/show/NCT02494206

Link

https://clinicaltrials.gov/show/NCT02494206

Keywords

Versions (1)
  1. 2/13/19 2/13/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 13, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02494206

English

Eligibility Breast Cancer NCT02494206

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women 18-70 with unilateral stage i or ii bcrl
Description

Gender | Age | Lymphedema Unilateral Stage | Lymphedema Breast Carcinoma Related

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0024236
UMLS CUI [3,2]
C0205092
UMLS CUI [3,3]
C1306673
UMLS CUI [4,1]
C0024236
UMLS CUI [4,2]
C0678222
UMLS CUI [4,3]
C0439849
volume difference of at least 400 ml between the normal and lymphedematous limb based on perometry evaluation
Description

Volume Difference | Normal shape of extremity | Lymphedema of limb | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C0449468
UMLS CUI [1,2]
C1705242
UMLS CUI [2]
C2919679
UMLS CUI [3]
C2584588
UMLS CUI [4]
C3846158
bmi of 18-30
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
no current evidence of breast cancer
Description

Breast Carcinoma Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0332197
at least 6 months postop from axillary lymph node dissection
Description

Postoperative Period | Excision of axillary lymph nodes

Data type

boolean

Alias
UMLS CUI [1]
C0032790
UMLS CUI [2]
C0193867
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
bilateral lymphedema or history of bilateral axillary lymph node dissection
Description

Lymphedema Bilateral | Excision of axillary lymph nodes Bilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0024236
UMLS CUI [1,2]
C0238767
UMLS CUI [2,1]
C0193867
UMLS CUI [2,2]
C0238767
recent history of cellulitis in the affected extremity (within last 3 months)
Description

Cellulitis Extremity Affected

Data type

boolean

Alias
UMLS CUI [1,1]
C0007642
UMLS CUI [1,2]
C0015385
UMLS CUI [1,3]
C0392760
recurrent breast cancer or other malignancy
Description

Breast cancer recurrent | Cancer Other Recurrent

Data type

boolean

Alias
UMLS CUI [1]
C0278493
UMLS CUI [2,1]
C1707251
UMLS CUI [2,2]
C2945760
current (within last month) use of chemotherapy for breast or other malignancy
Description

Chemotherapy Breast Carcinoma | Chemotherapy Cancer Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1707251
current (within last 3 months) use of radiation for breast or other malignancy
Description

Therapeutic radiology procedure Breast Carcinoma | Therapeutic radiology procedure Cancer Other

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1707251
recent (within last month) or current intensive mld and/or short stretch bandage use
Description

Manual Lymphatic Drainage With intensity | Use of Short stretch compression bandage

Data type

boolean

Alias
UMLS CUI [1,1]
C0556834
UMLS CUI [1,2]
C0522510
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C1282795
unstable lymphedema (i.e. worsening symptoms/measurements in the past 3 months)
Description

Lymphedema Unstable | Symptoms Worsening | Measurements Worsening

Data type

boolean

Alias
UMLS CUI [1,1]
C0024236
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0332271
UMLS CUI [3,1]
C0242485
UMLS CUI [3,2]
C0332271
pregnant or nursing (lactating) women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
stage iii lymphedema
Description

Lymphedema Stage

Data type

boolean

Alias
UMLS CUI [1,1]
C0024236
UMLS CUI [1,2]
C1306673
patients that take acetaminophen (paracetamol) chronically, i.e. more than 1 g/day for more than 3 out of 7 days, or more than 2 g/ day for more than 1 day out of 7 days
Description

Acetaminophen chronic U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0000970
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0456683
use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (e.g. monoclonal antibodies, polyclonal gamma globulin, polysorbates).
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar | Hypersensitivity Monoclonal Antibodies | Hypersensitivity Polyclonal gammaglobulins | Hypersensitivity Polysorbates

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C2348205
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0003250
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C1328603
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0032602
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Similar models

Eligibility Breast Cancer NCT02494206

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Lymphedema Unilateral Stage | Lymphedema Breast Carcinoma Related
Item
women 18-70 with unilateral stage i or ii bcrl
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0024236 (UMLS CUI [3,1])
C0205092 (UMLS CUI [3,2])
C1306673 (UMLS CUI [3,3])
C0024236 (UMLS CUI [4,1])
C0678222 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
Volume Difference | Normal shape of extremity | Lymphedema of limb | Other Coding
Item
volume difference of at least 400 ml between the normal and lymphedematous limb based on perometry evaluation
boolean
C0449468 (UMLS CUI [1,1])
C1705242 (UMLS CUI [1,2])
C2919679 (UMLS CUI [2])
C2584588 (UMLS CUI [3])
C3846158 (UMLS CUI [4])
Body mass index
Item
bmi of 18-30
boolean
C1305855 (UMLS CUI [1])
Breast Carcinoma Absent
Item
no current evidence of breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Postoperative Period | Excision of axillary lymph nodes
Item
at least 6 months postop from axillary lymph node dissection
boolean
C0032790 (UMLS CUI [1])
C0193867 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Lymphedema Bilateral | Excision of axillary lymph nodes Bilateral
Item
bilateral lymphedema or history of bilateral axillary lymph node dissection
boolean
C0024236 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C0193867 (UMLS CUI [2,1])
C0238767 (UMLS CUI [2,2])
Cellulitis Extremity Affected
Item
recent history of cellulitis in the affected extremity (within last 3 months)
boolean
C0007642 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
Breast cancer recurrent | Cancer Other Recurrent
Item
recurrent breast cancer or other malignancy
boolean
C0278493 (UMLS CUI [1])
C1707251 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
Chemotherapy Breast Carcinoma | Chemotherapy Cancer Other
Item
current (within last month) use of chemotherapy for breast or other malignancy
boolean
C0392920 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C1707251 (UMLS CUI [2,2])
Therapeutic radiology procedure Breast Carcinoma | Therapeutic radiology procedure Cancer Other
Item
current (within last 3 months) use of radiation for breast or other malignancy
boolean
C1522449 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1707251 (UMLS CUI [2,2])
Manual Lymphatic Drainage With intensity | Use of Short stretch compression bandage
Item
recent (within last month) or current intensive mld and/or short stretch bandage use
boolean
C0556834 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C1524063 (UMLS CUI [2,1])
C1282795 (UMLS CUI [2,2])
Lymphedema Unstable | Symptoms Worsening | Measurements Worsening
Item
unstable lymphedema (i.e. worsening symptoms/measurements in the past 3 months)
boolean
C0024236 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0332271 (UMLS CUI [2,2])
C0242485 (UMLS CUI [3,1])
C0332271 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing (lactating) women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Lymphedema Stage
Item
stage iii lymphedema
boolean
C0024236 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
Acetaminophen chronic U/day
Item
patients that take acetaminophen (paracetamol) chronically, i.e. more than 1 g/day for more than 3 out of 7 days, or more than 2 g/ day for more than 1 day out of 7 days
boolean
C0000970 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Investigational New Drugs
Item
use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar | Hypersensitivity Monoclonal Antibodies | Hypersensitivity Polyclonal gammaglobulins | Hypersensitivity Polysorbates
Item
history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (e.g. monoclonal antibodies, polyclonal gamma globulin, polysorbates).
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0003250 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C1328603 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0032602 (UMLS CUI [5,2])
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