ID

14787

Description

Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography; ODM derived from: https://clinicaltrials.gov/show/NCT02306265

Link

https://clinicaltrials.gov/show/NCT02306265

Keywords

Versions (1)
  1. 4/28/16 4/28/16 -
Uploaded on

April 28, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02306265

English

Eligibility Breast Cancer NCT02306265

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women aged 30 years or older (≥30 years old);
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
asymptomatic women scheduled for screening mammography or have completed a screening mammogram within the past 30 days;
Description

Gender Asymptomatic Screening mammography

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0231221
UMLS CUI [1,3]
C0203028
mammography completed on a ge ffdm system (with cc and mlo views) at the site or another clinical facility;
Description

Bilateral screening mammography, craniocaudal and mediolateral oblique views of each breast Full field digital mammogram

Data type

boolean

Alias
UMLS CUI [1,1]
C3866055
UMLS CUI [1,2]
C3862913
are able and willing to comply with study procedures;
Description

Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
have signed and dated the informed consent form;
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
are either surgically sterile or postmenopausal or, if of childbearing potential, the possibility of pregnancy is remote based on a documented negative patient history and, optionally, a negative urine pregnancy test (if subject requests one).
Description

Infertility Operative Surgical Procedures | Postmenopausal state | Childbearing Potential | Pregnancy | Patient History | Urine pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0021359
UMLS CUI [1,2]
C0543467
UMLS CUI [2]
C0232970
UMLS CUI [3]
C3831118
UMLS CUI [4]
C0032961
UMLS CUI [5]
C0679831
UMLS CUI [6]
C0430057
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have been previously included in this study;
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
have a history of breast cancer and are in active treatment. however, subjects with a prior lumpectomy (> 5 years prior) who receive only routine screening mammography views can be included;
Description

Breast Carcinoma Therapeutic procedure | Lumpectomy (breast cancer) | Mammography

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0087111
UMLS CUI [2]
C0740370
UMLS CUI [3]
C0024671
have breasts too large to be adequately positioned on 24 x 31 centimeter (cm) ffdm digital receptor without anatomical cut off during either ffdm or dbt examination;
Description

problem with female breast size | full field digital mammogram | Digital breast tomosynthesis

Data type

boolean

Alias
UMLS CUI [1]
C0850669
UMLS CUI [2]
C3862913
UMLS CUI [3]
C3472347
have participated in (within the prior 30 days) another trial of an investigational product expected to interfere with study procedures or outcomes;
Description

Study Subject Participation Status Affecting research results

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0683954
have breast implant(s);
Description

Breast Prosthesis, Internal

Data type

boolean

Alias
UMLS CUI [1]
C0179412
have reconstructed breast(s).
Description

Female breast Reconstructive Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0222603
UMLS CUI [1,2]
C0524865
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Similar models

Eligibility Breast Cancer NCT02306265

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women aged 30 years or older (≥30 years old);
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gender Asymptomatic Screening mammography
Item
asymptomatic women scheduled for screening mammography or have completed a screening mammogram within the past 30 days;
boolean
C0079399 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C0203028 (UMLS CUI [1,3])
Bilateral screening mammography, craniocaudal and mediolateral oblique views of each breast Full field digital mammogram
Item
mammography completed on a ge ffdm system (with cc and mlo views) at the site or another clinical facility;
boolean
C3866055 (UMLS CUI [1,1])
C3862913 (UMLS CUI [1,2])
Compliance behavior
Item
are able and willing to comply with study procedures;
boolean
C1321605 (UMLS CUI [1])
Informed Consent
Item
have signed and dated the informed consent form;
boolean
C0021430 (UMLS CUI [1])
Infertility Operative Surgical Procedures | Postmenopausal state | Childbearing Potential | Pregnancy | Patient History | Urine pregnancy test negative
Item
are either surgically sterile or postmenopausal or, if of childbearing potential, the possibility of pregnancy is remote based on a documented negative patient history and, optionally, a negative urine pregnancy test (if subject requests one).
boolean
C0021359 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
C0679831 (UMLS CUI [5])
C0430057 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
have been previously included in this study;
boolean
C2348568 (UMLS CUI [1])
Breast Carcinoma Therapeutic procedure | Lumpectomy (breast cancer) | Mammography
Item
have a history of breast cancer and are in active treatment. however, subjects with a prior lumpectomy (> 5 years prior) who receive only routine screening mammography views can be included;
boolean
C0678222 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0740370 (UMLS CUI [2])
C0024671 (UMLS CUI [3])
problem with female breast size | full field digital mammogram | Digital breast tomosynthesis
Item
have breasts too large to be adequately positioned on 24 x 31 centimeter (cm) ffdm digital receptor without anatomical cut off during either ffdm or dbt examination;
boolean
C0850669 (UMLS CUI [1])
C3862913 (UMLS CUI [2])
C3472347 (UMLS CUI [3])
Study Subject Participation Status Affecting research results
Item
have participated in (within the prior 30 days) another trial of an investigational product expected to interfere with study procedures or outcomes;
boolean
C2348568 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Breast Prosthesis, Internal
Item
have breast implant(s);
boolean
C0179412 (UMLS CUI [1])
Female breast Reconstructive Surgical Procedures
Item
have reconstructed breast(s).
boolean
C0222603 (UMLS CUI [1,1])
C0524865 (UMLS CUI [1,2])
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