ID

38077

Description

External-Beam Partial-Breast Irradiation for Early Breast Cancer 40 Gy QD Over 2 Weeks; ODM derived from: https://clinicaltrials.gov/show/NCT01581619

Link

https://clinicaltrials.gov/show/NCT01581619

Keywords

Versions (1)
  1. 9/16/19 9/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 16, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01581619

English

Eligibility Breast Cancer NCT01581619

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
unicentric stage i invasive ductal breast cancer or grade i or ii dcis measuring less than or equal to 2cm on pathology and/or mammography
Description

Invasive Ductal Breast Carcinoma Unicentric TNM Breast tumor staging | DCIS TNM Breast tumor staging Size Pathology | DCIS TNM Breast tumor staging Size Mammography

Data type

boolean

Alias
UMLS CUI [1,1]
C1134719
UMLS CUI [1,2]
C4518564
UMLS CUI [1,3]
C0474926
UMLS CUI [2,1]
C0007124
UMLS CUI [2,2]
C0474926
UMLS CUI [2,3]
C0456389
UMLS CUI [2,4]
C0919386
UMLS CUI [3,1]
C0007124
UMLS CUI [3,2]
C0474926
UMLS CUI [3,3]
C0456389
UMLS CUI [3,4]
C0024671
histologically negative tumor margin 2 mm or more from any inked edges, or no tumor in a re-excision specimen or final shaved specimen
Description

Negative Surgical Margin | Reexcision Specimen Free of Tumor

Data type

boolean

Alias
UMLS CUI [1]
C1709157
UMLS CUI [2,1]
C0184913
UMLS CUI [2,2]
C0370003
UMLS CUI [2,3]
C0332296
UMLS CUI [2,4]
C0027651
clips must be placed in the lumpectomy cavity at the time of final excision in order to aid in the delineation of the tumor cavity at the time of simulation and radiation delivery
Description

Clip placement Segmental Mastectomy Cavity | Excision

Data type

boolean

Alias
UMLS CUI [1,1]
C4489472
UMLS CUI [1,2]
C0024885
UMLS CUI [1,3]
C1510420
UMLS CUI [2]
C0728940
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no distant metastasis
Description

Distant metastasis

Data type

boolean

Alias
UMLS CUI [1]
C1269798
not pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
no diffuse suspicious microcalcifications
Description

Microcalcifications Diffuse Suspicious

Data type

boolean

Alias
UMLS CUI [1,1]
C0520594
UMLS CUI [1,2]
C0205219
UMLS CUI [1,3]
C0750493
no 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
no histologic evidence of lymphovascular invasion (lvi)
Description

Lymphatic Invasion

Data type

boolean

Alias
UMLS CUI [1]
C1708790
no histologic evidence of eic
Description

EIC

Data type

boolean

Alias
UMLS CUI [1]
C1882485
no history of cosmetic or reconstructive breast surgery
Description

Breast cosmetic surgery | Reconstructive breast surgery

Data type

boolean

Alias
UMLS CUI [1]
C0549358
UMLS CUI [2]
C1408823
no psychiatric illness that would prevent the patient from giving informed consent
Description

Mental disorder Preventing Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0021430
no medical conditions that, in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient
Description

Medical condition Study Subject Participation Status At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
no other currently active second malignancy other than non-melanoma skin cancers
Description

Second Primary Cancer | Exception Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
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Similar models

Eligibility Breast Cancer NCT01581619

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive Ductal Breast Carcinoma Unicentric TNM Breast tumor staging | DCIS TNM Breast tumor staging Size Pathology | DCIS TNM Breast tumor staging Size Mammography
Item
unicentric stage i invasive ductal breast cancer or grade i or ii dcis measuring less than or equal to 2cm on pathology and/or mammography
boolean
C1134719 (UMLS CUI [1,1])
C4518564 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C0007124 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
C0456389 (UMLS CUI [2,3])
C0919386 (UMLS CUI [2,4])
C0007124 (UMLS CUI [3,1])
C0474926 (UMLS CUI [3,2])
C0456389 (UMLS CUI [3,3])
C0024671 (UMLS CUI [3,4])
Negative Surgical Margin | Reexcision Specimen Free of Tumor
Item
histologically negative tumor margin 2 mm or more from any inked edges, or no tumor in a re-excision specimen or final shaved specimen
boolean
C1709157 (UMLS CUI [1])
C0184913 (UMLS CUI [2,1])
C0370003 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0027651 (UMLS CUI [2,4])
Clip placement Segmental Mastectomy Cavity | Excision
Item
clips must be placed in the lumpectomy cavity at the time of final excision in order to aid in the delineation of the tumor cavity at the time of simulation and radiation delivery
boolean
C4489472 (UMLS CUI [1,1])
C0024885 (UMLS CUI [1,2])
C1510420 (UMLS CUI [1,3])
C0728940 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Distant metastasis
Item
no distant metastasis
boolean
C1269798 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
not pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Microcalcifications Diffuse Suspicious
Item
no diffuse suspicious microcalcifications
boolean
C0520594 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C0750493 (UMLS CUI [1,3])
Prior radiation therapy Breast Ipsilateral | Prior radiation therapy Breast Contralateral | Prior radiation therapy Chest
Item
no 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])
Lymphatic Invasion
Item
no histologic evidence of lymphovascular invasion (lvi)
boolean
C1708790 (UMLS CUI [1])
EIC
Item
no histologic evidence of eic
boolean
C1882485 (UMLS CUI [1])
Breast cosmetic surgery | Reconstructive breast surgery
Item
no history of cosmetic or reconstructive breast surgery
boolean
C0549358 (UMLS CUI [1])
C1408823 (UMLS CUI [2])
Mental disorder Preventing Informed Consent
Item
no psychiatric illness that would prevent the patient from giving informed consent
boolean
C0004936 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Medical condition Study Subject Participation Status At risk
Item
no medical conditions that, in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
Second Primary Cancer | Exception Skin carcinoma
Item
no other currently active second malignancy other than non-melanoma skin cancers
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
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