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ID

14787

Beschreibung

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

Stichworte

  1. 28.04.16 28.04.16 -
Hochgeladen am

28. April 2016

DOI

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Lizenz

Creative Commons BY 4.0

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    Eligibility Breast Cancer NCT02306265

    Eligibility Breast Cancer NCT02306265

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

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

    Gender | Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [2]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    asymptomatic women scheduled for screening mammography or have completed a screening mammogram within the past 30 days;
    Beschreibung

    Gender Asymptomatic Screening mammography

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [1,2]
    C0231221 (Asymptomatic (finding))
    SNOMED
    84387000
    LOINC
    LA6737-6
    UMLS CUI [1,3]
    C0203028 (Screening mammography)
    SNOMED
    24623002
    mammography completed on a ge ffdm system (with cc and mlo views) at the site or another clinical facility;
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3866055 (undefined)
    UMLS CUI [1,2]
    C3862913 (full field digital mammogram)
    are able and willing to comply with study procedures;
    Beschreibung

    Compliance behavior

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    have signed and dated the informed consent form;
    Beschreibung

    Informed Consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    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).
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021359 (Infertility)
    SNOMED
    15296000
    UMLS CUI [1,2]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    UMLS CUI [2]
    C0232970 (Postmenopausal state)
    SNOMED
    76498008
    UMLS CUI [3]
    C3831118 (Childbearing Potential)
    UMLS CUI [4]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [5]
    C0679831 (Patient History)
    UMLS CUI [6]
    C0430057 (Urine pregnancy test negative)
    SNOMED
    167254001
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    have been previously included in this study;
    Beschreibung

    Study Subject Participation Status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    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;
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0678222 (Breast Carcinoma)
    SNOMED
    254838004
    UMLS CUI [1,2]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [2]
    C0740370 (Lumpectomy (breast cancer))
    UMLS CUI [3]
    C0024671 (Mammography)
    SNOMED
    71651007
    LOINC
    LP32234-4
    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;
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0850669 (problem with female breast size)
    UMLS CUI [2]
    C3862913 (full field digital mammogram)
    UMLS CUI [3]
    C3472347 (Digital Breast Tomosynthesis)
    SNOMED
    450566007
    have participated in (within the prior 30 days) another trial of an investigational product expected to interfere with study procedures or outcomes;
    Beschreibung

    Study Subject Participation Status Affecting research results

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [1,2]
    C0392760 (Affecting)
    SNOMED
    247591002
    UMLS CUI [1,3]
    C0683954 (research results)
    have breast implant(s);
    Beschreibung

    Breast Prosthesis, Internal

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0179412 (Breast Prosthesis, Internal)
    SNOMED
    2282003
    have reconstructed breast(s).
    Beschreibung

    Female breast Reconstructive Surgical Procedures

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0222603 (Female breast)
    SNOMED
    91532001
    UMLS CUI [1,2]
    C0524865 (Reconstructive Surgical Procedures)
    SNOMED
    122465003
    LOINC
    MTHU010401

    Ähnliche Modelle

    Eligibility Breast Cancer NCT02306265

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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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