ID

34984

Description

Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients With Implant Reconstructions; ODM derived from: https://clinicaltrials.gov/show/NCT02086578

Link

https://clinicaltrials.gov/show/NCT02086578

Keywords

Versions (1)
  1. 2/6/19 2/6/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 6, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02086578

English

Eligibility Breast Cancer NCT02086578

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
females who are age ≥ 18 years of age with a life expectancy estimated to be at least 2 years
Description

Gender | Age | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0023671
histologically-confirmed invasive breast cancer by mskcc
Description

Invasive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C0853879
eastern cooperative oncology group (ecog) performance status of 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
status post mastectomy with surgical assessment of axillary nodes
Description

Status post Mastectomy | Assessment Surgical Axillary nodes

Data type

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0024881
UMLS CUI [2,1]
C1516048
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C0729594
immediate reconstruction with tissue expander (group 2) or permanent implant (group 1) prior to rt performed at mskcc
Description

Reconstruction Immediate Tissue expander | Implant Permanent prior to Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0524865
UMLS CUI [1,2]
C0205253
UMLS CUI [1,3]
C0588162
UMLS CUI [2,1]
C0021102
UMLS CUI [2,2]
C0205355
UMLS CUI [2,3]
C0332152
UMLS CUI [2,4]
C1522449
if pmrt is recommended, the treatment fields will include the axillary, supraclavicular, and internal mammary nodes.
Description

Therapeutic radiology procedure Post Mastectomy | Radiation Field Axillary nodes | Radiation Field Supraclavicular nodes | Radiation Field Internal mammary nodes

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0024881
UMLS CUI [2,1]
C1882536
UMLS CUI [2,2]
C0729594
UMLS CUI [3,1]
C1882536
UMLS CUI [3,2]
C0229730
UMLS CUI [4,1]
C1882536
UMLS CUI [4,2]
C0542554
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
absence of a breast reconstruction prior to rt (placement of tissue expander is sufficient for group 2)
Description

Absence Mammaplasty prior to Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0085076
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C1522449
patients with nipple-sparing mastectomy
Description

Mastectomy, Subcutaneous

Data type

boolean

Alias
UMLS CUI [1]
C0024887
pregnant or breastfeeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
psychiatric or addictive disorders that would preclude obtaining informed consent or filling out breast-q© questionnaires.
Description

Mental disorders Exclude Informed Consent | Addictive Behavior Excludes Informed Consent | Mental disorders Exclude Questionnaire | Addictive Behavior Excludes Questionnaire

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0085281
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0034394
UMLS CUI [4,1]
C0085281
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C0034394
prior radiation therapy to the ipsilateral breast/nodes or thorax.
Description

Prior radiation therapy Breast Ipsilateral | Prior radiation therapy Lymph nodes Ipsilateral | Prior radiation therapy Chest Ipsilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C0441989
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0024204
UMLS CUI [2,3]
C0441989
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0817096
UMLS CUI [3,3]
C0441989
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Similar models

Eligibility Breast Cancer NCT02086578

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Life Expectancy
Item
females who are age ≥ 18 years of age with a life expectancy estimated to be at least 2 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
Invasive carcinoma of breast
Item
histologically-confirmed invasive breast cancer by mskcc
boolean
C0853879 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Status post Mastectomy | Assessment Surgical Axillary nodes
Item
status post mastectomy with surgical assessment of axillary nodes
boolean
C0231290 (UMLS CUI [1,1])
C0024881 (UMLS CUI [1,2])
C1516048 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0729594 (UMLS CUI [2,3])
Reconstruction Immediate Tissue expander | Implant Permanent prior to Therapeutic radiology procedure
Item
immediate reconstruction with tissue expander (group 2) or permanent implant (group 1) prior to rt performed at mskcc
boolean
C0524865 (UMLS CUI [1,1])
C0205253 (UMLS CUI [1,2])
C0588162 (UMLS CUI [1,3])
C0021102 (UMLS CUI [2,1])
C0205355 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C1522449 (UMLS CUI [2,4])
Therapeutic radiology procedure Post Mastectomy | Radiation Field Axillary nodes | Radiation Field Supraclavicular nodes | Radiation Field Internal mammary nodes
Item
if pmrt is recommended, the treatment fields will include the axillary, supraclavicular, and internal mammary nodes.
boolean
C1522449 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0024881 (UMLS CUI [1,3])
C1882536 (UMLS CUI [2,1])
C0729594 (UMLS CUI [2,2])
C1882536 (UMLS CUI [3,1])
C0229730 (UMLS CUI [3,2])
C1882536 (UMLS CUI [4,1])
C0542554 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Absence Mammaplasty prior to Therapeutic radiology procedure
Item
absence of a breast reconstruction prior to rt (placement of tissue expander is sufficient for group 2)
boolean
C0332197 (UMLS CUI [1,1])
C0085076 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
Mastectomy, Subcutaneous
Item
patients with nipple-sparing mastectomy
boolean
C0024887 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mental disorders Exclude Informed Consent | Addictive Behavior Excludes Informed Consent | Mental disorders Exclude Questionnaire | Addictive Behavior Excludes Questionnaire
Item
psychiatric or addictive disorders that would preclude obtaining informed consent or filling out breast-q© questionnaires.
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0085281 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0034394 (UMLS CUI [3,3])
C0085281 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0034394 (UMLS CUI [4,3])
Prior radiation therapy Breast Ipsilateral | Prior radiation therapy Lymph nodes Ipsilateral | Prior radiation therapy Chest Ipsilateral
Item
prior radiation therapy to the ipsilateral breast/nodes or thorax.
boolean
C0279134 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2,1])
C0024204 (UMLS CUI [2,2])
C0441989 (UMLS CUI [2,3])
C0279134 (UMLS CUI [3,1])
C0817096 (UMLS CUI [3,2])
C0441989 (UMLS CUI [3,3])
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