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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

  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

    Eligibility Breast Cancer NCT02306265

    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

    Similar models

    Eligibility Breast Cancer NCT02306265

    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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