ID

37820

Description

Role of 3D Tomography in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01090687

Link

https://clinicaltrials.gov/show/NCT01090687

Keywords

Versions (1)
  1. 8/26/19 8/26/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 26, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01090687

English

Eligibility Breast Cancer NCT01090687

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all women, age 40 or older, who are scheduled for biopsy after classification as bi-rads 4/5 and have had a screening or diagnostic full-field digital mammography (ffdm) exam are eligible to participate, except for exclusions noted below.
Description

Gender | Age | Biopsy Scheduled | BI-RADS | Full field digital mammogram

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0005558
UMLS CUI [3,2]
C0205539
UMLS CUI [4]
C1511314
UMLS CUI [5]
C3862913
able to provide informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
males
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
women less than 40 years old
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
pregnant women
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
lactating women
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
woman who have had bilateral mastectomies
Description

Bilateral mastectomy

Data type

boolean

Alias
UMLS CUI [1]
C0191877
women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker
Description

Physical impairment | Frozen shoulder | Cardiac Surgery procedures | Artificial cardiac pacemaker

Data type

boolean

Alias
UMLS CUI [1]
C0231171
UMLS CUI [2]
C0311223
UMLS CUI [3]
C0018821
UMLS CUI [4]
C0030163
women who are unable to tolerate study constraints, frail or unable to cooperate
Description

Clinical Trial Constraint intolerant | Frail | Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0443288
UMLS CUI [1,3]
C0231200
UMLS CUI [2]
C0871754
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C1299582
women with large breasts that cannot be accommodated within the field of view of the ct system
Description

Large breast Inappropriate CT Scan System

Data type

boolean

Alias
UMLS CUI [1,1]
C0235648
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0936234
women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)
Description

Radiotherapy to thorax Malignant disease | Radiotherapy to thorax Condition Non-Malignant

Data type

boolean

Alias
UMLS CUI [1,1]
C4038705
UMLS CUI [1,2]
C0442867
UMLS CUI [2,1]
C4038705
UMLS CUI [2,2]
C0348080
UMLS CUI [2,3]
C1518371
treatment for enlarged thymus gland as an infant
Description

Treatment Infant Thymus Gland Enlarged

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0021270
UMLS CUI [1,3]
C0040113
UMLS CUI [1,4]
C0442800
irradiation for benign breast conditions, including breast inflammation after giving birth
Description

Therapeutic radiology procedure Benign breast condition | Inflammatory disorder of breast Post Giving birth

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1635030
UMLS CUI [2,1]
C3495439
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0005615
treatment for hodgkin's disease
Description

Therapeutic procedure Hodgkin Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0019829
women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
Description

Study Subject Participation Status | Clinical Trial Breast | Radiation dose Additional | Mammogram Additional

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0006141
UMLS CUI [3,1]
C4019308
UMLS CUI [3,2]
C1524062
UMLS CUI [4,1]
C0024671
UMLS CUI [4,2]
C1524062
women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
Description

Diagnostic radiologic examination Numerous | Disease monitoring

Data type

boolean

Alias
UMLS CUI [1,1]
C0043299
UMLS CUI [1,2]
C0439064
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0150369
tuberculosis
Description

Tuberculosis

Data type

boolean

Alias
UMLS CUI [1]
C0041296
severe scoliosis
Description

Scoliosis, severe

Data type

boolean

Alias
UMLS CUI [1]
C2674596
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Similar models

Eligibility Breast Cancer NCT01090687

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Biopsy Scheduled | BI-RADS | Full field digital mammogram
Item
all women, age 40 or older, who are scheduled for biopsy after classification as bi-rads 4/5 and have had a screening or diagnostic full-field digital mammography (ffdm) exam are eligible to participate, except for exclusions noted below.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0005558 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
C1511314 (UMLS CUI [4])
C3862913 (UMLS CUI [5])
Informed Consent
Item
able to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Gender
Item
males
boolean
C0079399 (UMLS CUI [1])
Gender | Age
Item
women less than 40 years old
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
lactating women
boolean
C0006147 (UMLS CUI [1])
Bilateral mastectomy
Item
woman who have had bilateral mastectomies
boolean
C0191877 (UMLS CUI [1])
Physical impairment | Frozen shoulder | Cardiac Surgery procedures | Artificial cardiac pacemaker
Item
women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker
boolean
C0231171 (UMLS CUI [1])
C0311223 (UMLS CUI [2])
C0018821 (UMLS CUI [3])
C0030163 (UMLS CUI [4])
Clinical Trial Constraint intolerant | Frail | Compliance Unable
Item
women who are unable to tolerate study constraints, frail or unable to cooperate
boolean
C0008976 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
C0231200 (UMLS CUI [1,3])
C0871754 (UMLS CUI [2])
C1321605 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Large breast Inappropriate CT Scan System
Item
women with large breasts that cannot be accommodated within the field of view of the ct system
boolean
C0235648 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0936234 (UMLS CUI [1,3])
Radiotherapy to thorax Malignant disease | Radiotherapy to thorax Condition Non-Malignant
Item
women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)
boolean
C4038705 (UMLS CUI [1,1])
C0442867 (UMLS CUI [1,2])
C4038705 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C1518371 (UMLS CUI [2,3])
Treatment Infant Thymus Gland Enlarged
Item
treatment for enlarged thymus gland as an infant
boolean
C0087111 (UMLS CUI [1,1])
C0021270 (UMLS CUI [1,2])
C0040113 (UMLS CUI [1,3])
C0442800 (UMLS CUI [1,4])
Therapeutic radiology procedure Benign breast condition | Inflammatory disorder of breast Post Giving birth
Item
irradiation for benign breast conditions, including breast inflammation after giving birth
boolean
C1522449 (UMLS CUI [1,1])
C1635030 (UMLS CUI [1,2])
C3495439 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0005615 (UMLS CUI [2,3])
Therapeutic procedure Hodgkin Disease
Item
treatment for hodgkin's disease
boolean
C0087111 (UMLS CUI [1,1])
C0019829 (UMLS CUI [1,2])
Study Subject Participation Status | Clinical Trial Breast | Radiation dose Additional | Mammogram Additional
Item
women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0006141 (UMLS CUI [2,2])
C4019308 (UMLS CUI [3,1])
C1524062 (UMLS CUI [3,2])
C0024671 (UMLS CUI [4,1])
C1524062 (UMLS CUI [4,2])
Diagnostic radiologic examination Numerous | Disease monitoring
Item
women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
boolean
C0043299 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0150369 (UMLS CUI [2,2])
Tuberculosis
Item
tuberculosis
boolean
C0041296 (UMLS CUI [1])
Scoliosis, severe
Item
severe scoliosis
boolean
C2674596 (UMLS CUI [1])
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