ID

37846

Descripción

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

Palabras clave

Versiones (1)
  1. 27/8/19 27/8/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

27 de agosto de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01127373

Inglés

Eligibility Breast Cancer NCT01127373

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
female gender
Descripción

Gender

Tipo de datos

boolean

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

Age

Tipo de datos

boolean

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

Invasive carcinoma of breast | Origin Breast Parenchyma

Tipo de datos

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
Descripción

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with distant metastasis.
Descripción

Distant metastasis

Tipo de datos

boolean

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

Pregnancy | Breast Feeding

Tipo de datos

boolean

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

Mental disorders Exclude Informed Consent | Addictive Behavior Excludes Informed Consent

Tipo de datos

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.
Descripción

Diagnosis Initial Breast Carcinoma | Time Interval Start Therapeutic radiology procedure

Tipo de datos

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.
Descripción

Life Expectancy

Tipo de datos

boolean

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

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

Tipo de datos

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.
Descripción

Breast Carcinoma | Lymphoma Histology | Sarcoma Histology

Tipo de datos

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.
Descripción

Malignant Neoplasms Previous | Exception Skin Neoplasms

Tipo de datos

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.
Descripción

Patient need for Therapeutic radiology procedure Breasts Bilateral

Tipo de datos

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 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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