ID

37786

Description

Digital Mammography for the Detection and Preoperative Staging of Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01086514

Link

https://clinicaltrials.gov/show/NCT01086514

Keywords

Versions (1)
  1. 8/24/19 8/24/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 24, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01086514

English

Eligibility Breast Cancer NCT01086514

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with newly diagnosed unilateral breast cancer proven through core biopsy or fna who are planned to have (preoperative) mri within 30 days of de cedm to assess extent of disease/multifocality. (all women will have bilateral digital mammography as per standard of care.) the preoperative mri will be based on the surgeon's recommendation.
Description

Gender | Unilateral Breast Carcinoma Core needle biopsy | Unilateral Breast Carcinoma Fine needle aspiration | MRI Preoperative Planned | Dual-Energy Contrast-Enhanced Digital Spectral Mammography | Digital Mammography Bilateral

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C1710547
UMLS CUI [2,2]
C1318309
UMLS CUI [3,1]
C1710547
UMLS CUI [3,2]
C1510483
UMLS CUI [4,1]
C0024485
UMLS CUI [4,2]
C0445204
UMLS CUI [4,3]
C1301732
UMLS CUI [5]
C3899334
UMLS CUI [6,1]
C0860950
UMLS CUI [6,2]
C0238767
both breasts are present.
Description

Both breasts Present

Data type

boolean

Alias
UMLS CUI [1,1]
C0222605
UMLS CUI [1,2]
C0150312
women consenting to a bilateral de cedm examination.
Description

Consent Dual-Energy Contrast-Enhanced Digital Spectral Mammography Bilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C1511481
UMLS CUI [1,2]
C3899334
UMLS CUI [1,3]
C0238767
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women under 21.
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
women who have already had a lumpectomy. (index lesion has been removed and therefore, not evaluable for the purpose of this study.)
Description

Lumpectomy of breast Pre-existing

Data type

boolean

Alias
UMLS CUI [1,1]
C0851238
UMLS CUI [1,2]
C2347662
women undergoing neoadjuvant chemotherapy, hormone treatment, or radiation therapy.
Description

Neoadjuvant Chemotherapy | Hormone Therapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [2]
C0279025
UMLS CUI [3]
C1522449
known pregnancy.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
women who have a contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent.
Description

Medical contraindication Iodinated contrast dye Intravenous | Medical contraindication Gadolinium-based Contrast Agent Intravenous

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0879373
UMLS CUI [1,3]
C0348016
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C3249258
UMLS CUI [2,3]
C0348016
women with breast implants.
Description

Breast implants

Data type

boolean

Alias
UMLS CUI [1]
C0179412
women with pacemakers.
Description

Artificial cardiac pacemaker

Data type

boolean

Alias
UMLS CUI [1]
C0030163
women with aneurysm clips that don't allow for mri.
Description

Aneurysm clip Preventing MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0179977
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0024485
women too claustrophobic to undergo mri.
Description

Claustrophobia Preventing MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0008909
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0024485
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Similar models

Eligibility Breast Cancer NCT01086514

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Unilateral Breast Carcinoma Core needle biopsy | Unilateral Breast Carcinoma Fine needle aspiration | MRI Preoperative Planned | Dual-Energy Contrast-Enhanced Digital Spectral Mammography | Digital Mammography Bilateral
Item
women with newly diagnosed unilateral breast cancer proven through core biopsy or fna who are planned to have (preoperative) mri within 30 days of de cedm to assess extent of disease/multifocality. (all women will have bilateral digital mammography as per standard of care.) the preoperative mri will be based on the surgeon's recommendation.
boolean
C0079399 (UMLS CUI [1])
C1710547 (UMLS CUI [2,1])
C1318309 (UMLS CUI [2,2])
C1710547 (UMLS CUI [3,1])
C1510483 (UMLS CUI [3,2])
C0024485 (UMLS CUI [4,1])
C0445204 (UMLS CUI [4,2])
C1301732 (UMLS CUI [4,3])
C3899334 (UMLS CUI [5])
C0860950 (UMLS CUI [6,1])
C0238767 (UMLS CUI [6,2])
Both breasts Present
Item
both breasts are present.
boolean
C0222605 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Consent Dual-Energy Contrast-Enhanced Digital Spectral Mammography Bilateral
Item
women consenting to a bilateral de cedm examination.
boolean
C1511481 (UMLS CUI [1,1])
C3899334 (UMLS CUI [1,2])
C0238767 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Gender | Age
Item
women under 21.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Lumpectomy of breast Pre-existing
Item
women who have already had a lumpectomy. (index lesion has been removed and therefore, not evaluable for the purpose of this study.)
boolean
C0851238 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Neoadjuvant Chemotherapy | Hormone Therapy | Therapeutic radiology procedure
Item
women undergoing neoadjuvant chemotherapy, hormone treatment, or radiation therapy.
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
Pregnancy
Item
known pregnancy.
boolean
C0032961 (UMLS CUI [1])
Medical contraindication Iodinated contrast dye Intravenous | Medical contraindication Gadolinium-based Contrast Agent Intravenous
Item
women who have a contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent.
boolean
C1301624 (UMLS CUI [1,1])
C0879373 (UMLS CUI [1,2])
C0348016 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C3249258 (UMLS CUI [2,2])
C0348016 (UMLS CUI [2,3])
Breast implants
Item
women with breast implants.
boolean
C0179412 (UMLS CUI [1])
Artificial cardiac pacemaker
Item
women with pacemakers.
boolean
C0030163 (UMLS CUI [1])
Aneurysm clip Preventing MRI
Item
women with aneurysm clips that don't allow for mri.
boolean
C0179977 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
Claustrophobia Preventing MRI
Item
women too claustrophobic to undergo mri.
boolean
C0008909 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
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