ID

37776

Description

To Evaluate the Characteristics of a Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01055678

Link

https://clinicaltrials.gov/show/NCT01055678

Keywords

Versions (1)
  1. 8/23/19 8/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01055678

English

Eligibility Breast Cancer NCT01055678

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed stage 0 - iii invasive carcinoma of the breast
Description

Invasive carcinoma of breast TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
tumor size greater than 1-cm by radiological (mammogram/ultrasound or mri) evaluation
Description

Tumor size Radiologic Examination | Tumor size Mammography | Tumor size Ultrasonography | Tumor size MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C2985535
UMLS CUI [2,1]
C0475440
UMLS CUI [2,2]
C0024671
UMLS CUI [3,1]
C0475440
UMLS CUI [3,2]
C0041618
UMLS CUI [4,1]
C0475440
UMLS CUI [4,2]
C0024485
kps status ≥ 70
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
bilirubin ≤ 1.5x normal
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
creatinine ≤ 1.8
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
wbc > 3000/mm^3 and platelets > 100,000/mm^3
Description

White Blood Cell Count procedure | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0032181
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast-feeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
neoadjuvant chemo or hormonal therapy for existent breast malignancy
Description

Neoadjuvant Chemotherapy Breast Carcinoma | Neoadjuvant Hormone Therapy Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0279025
UMLS CUI [2,3]
C0678222
allergy to iv contrast dye
Description

Allergy to intravenous contrast media

Data type

boolean

Alias
UMLS CUI [1]
C2242530
history of grade iii or iv peripheral neuropathy as defined by the nci ctc
Description

Peripheral Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
previous history of any malignancy treated with radiotherapy and/or chemohormonal therapy
Description

Therapeutic radiology procedure Malignant Neoplasms | Chemotherapy Malignant Neoplasms | Hormone Therapy Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0006826
UMLS CUI [3,1]
C0279025
UMLS CUI [3,2]
C0006826
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Similar models

Eligibility Breast Cancer NCT01055678

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast TNM Breast tumor staging
Item
histologically confirmed stage 0 - iii invasive carcinoma of the breast
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Tumor size Radiologic Examination | Tumor size Mammography | Tumor size Ultrasonography | Tumor size MRI
Item
tumor size greater than 1-cm by radiological (mammogram/ultrasound or mri) evaluation
boolean
C0475440 (UMLS CUI [1,1])
C2985535 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2,1])
C0024671 (UMLS CUI [2,2])
C0475440 (UMLS CUI [3,1])
C0041618 (UMLS CUI [3,2])
C0475440 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
Karnofsky Performance Status
Item
kps status ≥ 70
boolean
C0206065 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin ≤ 1.5x normal
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine ≤ 1.8
boolean
C0201976 (UMLS CUI [1])
White Blood Cell Count procedure | Platelet Count measurement
Item
wbc > 3000/mm^3 and platelets > 100,000/mm^3
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Neoadjuvant Chemotherapy Breast Carcinoma | Neoadjuvant Hormone Therapy Breast Carcinoma
Item
neoadjuvant chemo or hormonal therapy for existent breast malignancy
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0600558 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
Allergy to intravenous contrast media
Item
allergy to iv contrast dye
boolean
C2242530 (UMLS CUI [1])
Peripheral Neuropathy CTCAE Grades
Item
history of grade iii or iv peripheral neuropathy as defined by the nci ctc
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Therapeutic radiology procedure Malignant Neoplasms | Chemotherapy Malignant Neoplasms | Hormone Therapy Malignant Neoplasms
Item
previous history of any malignancy treated with radiotherapy and/or chemohormonal therapy
boolean
C1522449 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
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