ID

37846

Description

Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01127373

Link

https://clinicaltrials.gov/show/NCT01127373

Keywords

Versions (1)
  1. 8/27/19 8/27/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 27, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01127373

English

Eligibility Breast Cancer NCT01127373

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female gender
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
age ≥18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
an invasive primary breast cancer of any histology arising from breast parenchyma
Description

Invasive carcinoma of breast | Origin Breast Parenchyma

Data type

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2,1]
C0439659
UMLS CUI [2,2]
C0006141
UMLS CUI [2,3]
C0933845
patient must be status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection
Description

Status post Mastectomy | Status post Segmental Mastectomy | Axillary lymph nodes Sentinel Lymph Node Biopsy | Excision of axillary lymph nodes

Data type

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0024881
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0024885
UMLS CUI [3,1]
C0729594
UMLS CUI [3,2]
C0796693
UMLS CUI [4]
C0193867
pathologic confirmation of metastatic disease in at least one regional lymph node. regional lymph nodes are defined as the ipsilateral axillary lymph nodes, ipsilateral supraclavicular lymph nodes, and ipsilateral internal mammary lymph nodes. thus, any t stage is allowed as long as the n stage is ≥1 and m stage is 0.
Description

Neoplasm Metastasis Regional lymph node Quantity | Axillary lymph nodes Ipsilateral | Supraclavicular lymph node Ipsilateral | Internal Mammary Lymph Node Ipsilateral | Disease TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C4517003
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0729594
UMLS CUI [2,2]
C0441989
UMLS CUI [3,1]
C1280309
UMLS CUI [3,2]
C0441989
UMLS CUI [4,1]
C0229755
UMLS CUI [4,2]
C0441989
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0474926
patient signed study-specific consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with distant metastasis.
Description

Distant metastasis

Data type

boolean

Alias
UMLS CUI [1]
C1269798
patients who are pregnant or breastfeeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with psychiatric or addictive disorders that would preclude obtaining informed consent.
Description

Mental disorders Exclude Informed Consent | Addictive Behavior Excludes Informed Consent

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
time between initial diagnosis of breast cancer and start of radiation therapy exceeds 13 months.
Description

Diagnosis Initial Breast Carcinoma | Time Interval Start Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0205265
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0872291
UMLS CUI [2,2]
C0439659
UMLS CUI [2,3]
C1522449
estimated life expectancy judged to be less than one year by patient's treating radiation oncologist.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
prior radiation therapy to the ipsilateral or contralateral breast or thorax.
Description

Prior radiation therapy Breast Ipsilateral | Prior radiation therapy Breast Contralateral | Prior radiation therapy Chest

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]
C0006141
UMLS CUI [2,3]
C0441988
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0817096
primary breast cancer is a lymphoma or sarcoma histology.
Description

Breast Carcinoma | Lymphoma Histology | Sarcoma Histology

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C0024299
UMLS CUI [2,2]
C4048239
UMLS CUI [3,1]
C1261473
UMLS CUI [3,2]
C4048239
patients with a history of non-skin malignancy <5 years prior to the diagnosis of breast cancer.
Description

Malignant Neoplasms Previous | Exception Skin Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0037286
patients requiring radiation to the bilateral breasts.
Description

Patient need for Therapeutic radiology procedure Breasts Bilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0006141
UMLS CUI [1,4]
C0238767
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Similar models

Eligibility Breast Cancer NCT01127373

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
female gender
boolean
C0079399 (UMLS CUI [1])
Age
Item
age ≥18 years
boolean
C0001779 (UMLS CUI [1])
Invasive carcinoma of breast | Origin Breast Parenchyma
Item
an invasive primary breast cancer of any histology arising from breast parenchyma
boolean
C0853879 (UMLS CUI [1])
C0439659 (UMLS CUI [2,1])
C0006141 (UMLS CUI [2,2])
C0933845 (UMLS CUI [2,3])
Status post Mastectomy | Status post Segmental Mastectomy | Axillary lymph nodes Sentinel Lymph Node Biopsy | Excision of axillary lymph nodes
Item
patient must be status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection
boolean
C0231290 (UMLS CUI [1,1])
C0024881 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0024885 (UMLS CUI [2,2])
C0729594 (UMLS CUI [3,1])
C0796693 (UMLS CUI [3,2])
C0193867 (UMLS CUI [4])
Neoplasm Metastasis Regional lymph node Quantity | Axillary lymph nodes Ipsilateral | Supraclavicular lymph node Ipsilateral | Internal Mammary Lymph Node Ipsilateral | Disease TNM Breast tumor staging
Item
pathologic confirmation of metastatic disease in at least one regional lymph node. regional lymph nodes are defined as the ipsilateral axillary lymph nodes, ipsilateral supraclavicular lymph nodes, and ipsilateral internal mammary lymph nodes. thus, any t stage is allowed as long as the n stage is ≥1 and m stage is 0.
boolean
C0027627 (UMLS CUI [1,1])
C4517003 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0729594 (UMLS CUI [2,1])
C0441989 (UMLS CUI [2,2])
C1280309 (UMLS CUI [3,1])
C0441989 (UMLS CUI [3,2])
C0229755 (UMLS CUI [4,1])
C0441989 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0474926 (UMLS CUI [5,2])
Informed Consent
Item
patient signed study-specific consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Distant metastasis
Item
patients with distant metastasis.
boolean
C1269798 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
patients who are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mental disorders Exclude Informed Consent | Addictive Behavior Excludes Informed Consent
Item
patients with psychiatric or addictive disorders that would preclude obtaining informed consent.
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])
Diagnosis Initial Breast Carcinoma | Time Interval Start Therapeutic radiology procedure
Item
time between initial diagnosis of breast cancer and start of radiation therapy exceeds 13 months.
boolean
C0011900 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0872291 (UMLS CUI [2,1])
C0439659 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
Life Expectancy
Item
estimated life expectancy judged to be less than one year by patient's treating radiation oncologist.
boolean
C0023671 (UMLS CUI [1])
Prior radiation therapy Breast Ipsilateral | Prior radiation therapy Breast Contralateral | Prior radiation therapy Chest
Item
prior radiation therapy to the ipsilateral or contralateral breast or thorax.
boolean
C0279134 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2,1])
C0006141 (UMLS CUI [2,2])
C0441988 (UMLS CUI [2,3])
C0279134 (UMLS CUI [3,1])
C0817096 (UMLS CUI [3,2])
Breast Carcinoma | Lymphoma Histology | Sarcoma Histology
Item
primary breast cancer is a lymphoma or sarcoma histology.
boolean
C0678222 (UMLS CUI [1])
C0024299 (UMLS CUI [2,1])
C4048239 (UMLS CUI [2,2])
C1261473 (UMLS CUI [3,1])
C4048239 (UMLS CUI [3,2])
Malignant Neoplasms Previous | Exception Skin Neoplasms
Item
patients with a history of non-skin malignancy <5 years prior to the diagnosis of breast cancer.
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0037286 (UMLS CUI [2,2])
Patient need for Therapeutic radiology procedure Breasts Bilateral
Item
patients requiring radiation to the bilateral breasts.
boolean
C0686904 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C0238767 (UMLS CUI [1,4])
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