ID

26569

Description

Efficacy of Tomosynthesis in the BIRADS 3 Population; ODM derived from: https://clinicaltrials.gov/show/NCT00763100

Link

https://clinicaltrials.gov/show/NCT00763100

Keywords

Versions (1)
  1. 10/19/17 10/19/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 19, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00763100

English

Eligibility Breast Cancer NCT00763100

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
group 1
Description

Group

Data type

boolean

Alias
UMLS CUI [1]
C0441833
female of any race and ethnicity
Description

Gender | Racial group Any | Ethnicity Any

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0034510
UMLS CUI [2,2]
C1552551
UMLS CUI [3,1]
C0015031
UMLS CUI [3,2]
C1552551
35 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
after routine and diagnostic imaging, subject is categorized as a bi-rads 3 and will undergo study imaging within 30 days of routine or diagnostic imaging.
Description

Medical Imaging | Diagnostic Imaging | BI-RADS | Clinical Trial Imaging

Data type

boolean

Alias
UMLS CUI [1]
C0025086
UMLS CUI [2]
C0011923
UMLS CUI [3]
C1511314
UMLS CUI [4,1]
C0008976
UMLS CUI [4,2]
C0025086
subject is returning for surveillance imaging after a categorization of a bi-rads 3 and will undergo study imaging within 30 days of surveillance imaging group 2
Description

Return to Surveillance Imaging | BI-RADS | Clinical Trial Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0332156
UMLS CUI [1,2]
C0733511
UMLS CUI [1,3]
C0025086
UMLS CUI [2]
C1511314
UMLS CUI [3,1]
C0008976
UMLS CUI [3,2]
C0025086
female of any race and ethnicity
Description

Gender | Racial group Any | Ethnicity Any

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0034510
UMLS CUI [2,2]
C1552551
UMLS CUI [3,1]
C0015031
UMLS CUI [3,2]
C1552551
26 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subject has completed cancer treatment and is currently categorized as a bi-rads 3 for surveillance imaging
Description

Cancer treatment Completed | BI-RADS Surveillance Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C1511314
UMLS CUI [2,2]
C0733511
UMLS CUI [2,3]
C0025086
subject will undergo study imaging within 30 days of surveillance imaging group 3
Description

Clinical Trial Imaging | Surveillance Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0025086
UMLS CUI [2,1]
C0733511
UMLS CUI [2,2]
C0025086
female of any race and ethnicity
Description

Gender | Racial group Any | Ethnicity Any

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0034510
UMLS CUI [2,2]
C1552551
UMLS CUI [3,1]
C0015031
UMLS CUI [3,2]
C1552551
26 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subject is currently undergoing cancer treatment and is currently categorized as a bi-rads 3 for surveillance imaging or
Description

Cancer treatment | BI-RADS Surveillance Imaging

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C1511314
UMLS CUI [2,2]
C0733511
UMLS CUI [2,3]
C0025086
subject will undergo study imaging within 30 days of surveillance imaging
Description

Clinical Trial Imaging | Surveillance Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0025086
UMLS CUI [2,1]
C0733511
UMLS CUI [2,2]
C0025086
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
group 1, 2 and 3
Description

Groups

Data type

boolean

Alias
UMLS CUI [1]
C0441833
subjects unable or unwilling to participate
Description

Study Subject Participation Status Unable | Study Subject Participation Status Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0558080
subjects who are unable or unwilling to tolerate compression
Description

Receive Compression Unable | Receive Compression Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C1514756
UMLS CUI [1,2]
C0565514
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C1514756
UMLS CUI [2,2]
C0565514
UMLS CUI [2,3]
C0558080
subjects who are pregnant or who think they may be pregnant
Description

Pregnancy | Possible pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0425965
subjects who are breastfeeding
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Breast Cancer NCT00763100

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Group
Item
group 1
boolean
C0441833 (UMLS CUI [1])
Gender | Racial group Any | Ethnicity Any
Item
female of any race and ethnicity
boolean
C0079399 (UMLS CUI [1])
C0034510 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
C0015031 (UMLS CUI [3,1])
C1552551 (UMLS CUI [3,2])
Age
Item
35 years or older
boolean
C0001779 (UMLS CUI [1])
Medical Imaging | Diagnostic Imaging | BI-RADS | Clinical Trial Imaging
Item
after routine and diagnostic imaging, subject is categorized as a bi-rads 3 and will undergo study imaging within 30 days of routine or diagnostic imaging.
boolean
C0025086 (UMLS CUI [1])
C0011923 (UMLS CUI [2])
C1511314 (UMLS CUI [3])
C0008976 (UMLS CUI [4,1])
C0025086 (UMLS CUI [4,2])
Return to Surveillance Imaging | BI-RADS | Clinical Trial Imaging
Item
subject is returning for surveillance imaging after a categorization of a bi-rads 3 and will undergo study imaging within 30 days of surveillance imaging group 2
boolean
C0332156 (UMLS CUI [1,1])
C0733511 (UMLS CUI [1,2])
C0025086 (UMLS CUI [1,3])
C1511314 (UMLS CUI [2])
C0008976 (UMLS CUI [3,1])
C0025086 (UMLS CUI [3,2])
Gender | Racial group Any | Ethnicity Any
Item
female of any race and ethnicity
boolean
C0079399 (UMLS CUI [1])
C0034510 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
C0015031 (UMLS CUI [3,1])
C1552551 (UMLS CUI [3,2])
Age
Item
26 years or older
boolean
C0001779 (UMLS CUI [1])
Cancer treatment Completed | BI-RADS Surveillance Imaging
Item
subject has completed cancer treatment and is currently categorized as a bi-rads 3 for surveillance imaging
boolean
C0920425 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1511314 (UMLS CUI [2,1])
C0733511 (UMLS CUI [2,2])
C0025086 (UMLS CUI [2,3])
Clinical Trial Imaging | Surveillance Imaging
Item
subject will undergo study imaging within 30 days of surveillance imaging group 3
boolean
C0008976 (UMLS CUI [1,1])
C0025086 (UMLS CUI [1,2])
C0733511 (UMLS CUI [2,1])
C0025086 (UMLS CUI [2,2])
Gender | Racial group Any | Ethnicity Any
Item
female of any race and ethnicity
boolean
C0079399 (UMLS CUI [1])
C0034510 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
C0015031 (UMLS CUI [3,1])
C1552551 (UMLS CUI [3,2])
Age
Item
26 years or older
boolean
C0001779 (UMLS CUI [1])
Cancer treatment | BI-RADS Surveillance Imaging
Item
subject is currently undergoing cancer treatment and is currently categorized as a bi-rads 3 for surveillance imaging or
boolean
C0920425 (UMLS CUI [1])
C1511314 (UMLS CUI [2,1])
C0733511 (UMLS CUI [2,2])
C0025086 (UMLS CUI [2,3])
Clinical Trial Imaging | Surveillance Imaging
Item
subject will undergo study imaging within 30 days of surveillance imaging
boolean
C0008976 (UMLS CUI [1,1])
C0025086 (UMLS CUI [1,2])
C0733511 (UMLS CUI [2,1])
C0025086 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Groups
Item
group 1, 2 and 3
boolean
C0441833 (UMLS CUI [1])
Study Subject Participation Status Unable | Study Subject Participation Status Unwilling
Item
subjects unable or unwilling to participate
boolean
C2348568 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Receive Compression Unable | Receive Compression Unwilling
Item
subjects who are unable or unwilling to tolerate compression
boolean
C1514756 (UMLS CUI [1,1])
C0565514 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1514756 (UMLS CUI [2,1])
C0565514 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Pregnancy | Possible pregnancy
Item
subjects who are pregnant or who think they may be pregnant
boolean
C0032961 (UMLS CUI [1])
C0425965 (UMLS CUI [2])
Breast Feeding
Item
subjects who are breastfeeding
boolean
C0006147 (UMLS CUI [1])
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