ID

38244

Beskrivning

Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates; ODM derived from: https://clinicaltrials.gov/show/NCT01236781

Länk

https://clinicaltrials.gov/show/NCT01236781

Nyckelord

Versioner (1)
  1. 2019-10-01 2019-10-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 oktober 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01236781

Engelsk

Eligibility Breast Neoplasms NCT01236781

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
women 25 years of age or older;
Beskrivning

Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
no history of breast cancer;
Beskrivning

Medical History Breast Carcinoma Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C0332197
group a only: asymptomatic and scheduled for screening mammography;
Beskrivning

Asymptomatic | Screening mammography Scheduled

Datatyp

boolean

Alias
UMLS CUI [1]
C0231221
UMLS CUI [2,1]
C0203028
UMLS CUI [2,2]
C0205539
group b only: asymptomatic and recalled for diagnostic testing due to positive findings on recent screening using ffdm, completed within 30 days prior to registration (bi-rads 0: additional imaging needed);
Beskrivning

Asymptomatic | Diagnostic Testing Repeated | Etiology Positive Finding Full field digital mammogram | BI-RADS Required | Imaging Additional Required

Datatyp

boolean

Alias
UMLS CUI [1]
C0231221
UMLS CUI [2,1]
C2364357
UMLS CUI [2,2]
C0205341
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C1514241
UMLS CUI [3,3]
C3862913
UMLS CUI [4,1]
C1511314
UMLS CUI [4,2]
C1514873
UMLS CUI [5,1]
C0011923
UMLS CUI [5,2]
C1524062
UMLS CUI [5,3]
C1514873
willing to provide a written informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or intent to become pregnant;
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
unable or unwilling to tolerate compression associated with mammography;
Beskrivning

Mammogram in compression view Receive Unable | Mammogram in compression view Receive Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2584965
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C2584965
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C0558080
breast implants;
Beskrivning

Breast implants

Datatyp

boolean

Alias
UMLS CUI [1]
C0179412
breasts too large to allow for adequate positioning for the dbt examination;
Beskrivning

Large breast Inappropriate Digital Breast Tomosynthesis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0235648
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C3472347
group b only: patients with ffdm taken at screening who are unwilling or unable to submit images to acrin;
Beskrivning

Full field digital mammogram | Result Submit Unwilling | Result Submit Unable

Datatyp

boolean

Alias
UMLS CUI [1]
C3862913
UMLS CUI [2,1]
C1274040
UMLS CUI [2,2]
C1515023
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C1274040
UMLS CUI [3,2]
C1515023
UMLS CUI [3,3]
C1299582
group b only: unwilling to undergo tomosynthesis on both breasts as well as potentially additional diagnostic imaging based on tomosynthesis findings;
Beskrivning

Tomosynthesis Both breasts Unwilling | Diagnostic Imaging Additional Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3472347
UMLS CUI [1,2]
C0222605
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C1524062
UMLS CUI [2,3]
C0558080
unable or unwilling to complete screening and (as necessary) diagnostic imaging at same facility;
Beskrivning

Screening Completion Unable | Screening Completion Unwilling | Diagnostic Imaging Completion Unable | Diagnostic Imaging Completion Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1710032
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C1710032
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C0011923
UMLS CUI [3,2]
C0205197
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C0011923
UMLS CUI [4,2]
C0205197
UMLS CUI [4,3]
C0558080
tomosynthesis or mammography within 11 months prior to registration (excluding the screening mammography required for group b).
Beskrivning

Tomosynthesis Recently | Mammography Recently

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3472347
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0024671
UMLS CUI [2,2]
C0332185
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Similar models

Eligibility Breast Neoplasms NCT01236781

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women 25 years of age or older;
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Medical History Breast Carcinoma Absent
Item
no history of breast cancer;
boolean
C0262926 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Asymptomatic | Screening mammography Scheduled
Item
group a only: asymptomatic and scheduled for screening mammography;
boolean
C0231221 (UMLS CUI [1])
C0203028 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Asymptomatic | Diagnostic Testing Repeated | Etiology Positive Finding Full field digital mammogram | BI-RADS Required | Imaging Additional Required
Item
group b only: asymptomatic and recalled for diagnostic testing due to positive findings on recent screening using ffdm, completed within 30 days prior to registration (bi-rads 0: additional imaging needed);
boolean
C0231221 (UMLS CUI [1])
C2364357 (UMLS CUI [2,1])
C0205341 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C3862913 (UMLS CUI [3,3])
C1511314 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0011923 (UMLS CUI [5,1])
C1524062 (UMLS CUI [5,2])
C1514873 (UMLS CUI [5,3])
Informed Consent
Item
willing to provide a written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Pregnancy, Planned
Item
pregnancy or intent to become pregnant;
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Mammogram in compression view Receive Unable | Mammogram in compression view Receive Unwilling
Item
unable or unwilling to tolerate compression associated with mammography;
boolean
C2584965 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C2584965 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Breast implants
Item
breast implants;
boolean
C0179412 (UMLS CUI [1])
Large breast Inappropriate Digital Breast Tomosynthesis
Item
breasts too large to allow for adequate positioning for the dbt examination;
boolean
C0235648 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C3472347 (UMLS CUI [1,3])
Full field digital mammogram | Result Submit Unwilling | Result Submit Unable
Item
group b only: patients with ffdm taken at screening who are unwilling or unable to submit images to acrin;
boolean
C3862913 (UMLS CUI [1])
C1274040 (UMLS CUI [2,1])
C1515023 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C1274040 (UMLS CUI [3,1])
C1515023 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Tomosynthesis Both breasts Unwilling | Diagnostic Imaging Additional Unwilling
Item
group b only: unwilling to undergo tomosynthesis on both breasts as well as potentially additional diagnostic imaging based on tomosynthesis findings;
boolean
C3472347 (UMLS CUI [1,1])
C0222605 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0011923 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Screening Completion Unable | Screening Completion Unwilling | Diagnostic Imaging Completion Unable | Diagnostic Imaging Completion Unwilling
Item
unable or unwilling to complete screening and (as necessary) diagnostic imaging at same facility;
boolean
C1710032 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1710032 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0011923 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0011923 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Tomosynthesis Recently | Mammography Recently
Item
tomosynthesis or mammography within 11 months prior to registration (excluding the screening mammography required for group b).
boolean
C3472347 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0024671 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
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