ID

37820

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01090687

Nyckelord

Versioner (1)
  1. 2019-08-26 2019-08-26 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

26 augusti 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01090687

Engelsk

Eligibility Breast Cancer NCT01090687

1 Formulär  
Inclusion Criteria
Beskrivning

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
males
Beskrivning

Gender

Datatyp

boolean

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

Gender | Age

Datatyp

boolean

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

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
lactating women
Beskrivning

Breast Feeding

Datatyp

boolean

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

Bilateral mastectomy

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Clinical Trial Constraint intolerant | Frail | Compliance Unable

Datatyp

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
Beskrivning

Large breast Inappropriate CT Scan System

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Treatment Infant Thymus Gland Enlarged

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Therapeutic procedure Hodgkin Disease

Datatyp

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.
Beskrivning

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

Datatyp

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)
Beskrivning

Diagnostic radiologic examination Numerous | Disease monitoring

Datatyp

boolean

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

Tuberculosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0041296
severe scoliosis
Beskrivning

Scoliosis, severe

Datatyp

boolean

Alias
UMLS CUI [1]
C2674596
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Similar models

Eligibility Breast Cancer NCT01090687

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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