ID

14880

Beskrivning

Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02271828

Länk

https://clinicaltrials.gov/show/NCT02271828

Nyckelord

Versioner (1)
  1. 2016-05-03 2016-05-03 -
Uppladdad den

3 maj 2016

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Breast Neoplasms NCT02271828

    Engelsk

    Eligibility Breast Neoplasms NCT02271828

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    female
    Beskrivning

    Gender

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    aged 18 years or older
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    pathologically confirmed invasive breast carcinoma
    Beskrivning

    Invasive breast carcinoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0853879
    a clinical t1-2 tumor
    Beskrivning

    Tumor stage T1 | Tumor stage T2

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0475372
    UMLS CUI [2]
    C0475373
    will be treated with lumpectomy and whole breast radiotherapy
    Beskrivning

    Lumpectomy (breast cancer) | Whole breast Therapeutic radiology procedure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0740370
    UMLS CUI [2,1]
    C0457102
    UMLS CUI [2,2]
    C1522449
    clinically node negative status: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
    Beskrivning

    Clinically node negative (t1n0m0) or t2n0m0) invasive breast cancer | Axillary lymph node level Absence of signs Neoplasm Metastasis | Physical Examination | Ultrasonics (sound) Preoperative Axilla | Cytopathology finding Negative | Histopathology finding Negative

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3248613
    UMLS CUI [2,1]
    C0441924
    UMLS CUI [2,2]
    C0277791
    UMLS CUI [2,3]
    C0027627
    UMLS CUI [3]
    C0031809
    UMLS CUI [4,1]
    C1456803
    UMLS CUI [4,2]
    C0445204
    UMLS CUI [4,3]
    C0004454
    UMLS CUI [5,1]
    C0456521
    UMLS CUI [5,2]
    C0205160
    UMLS CUI [6,1]
    C0428093
    UMLS CUI [6,2]
    C0205160
    written informed consent
    Beskrivning

    Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    clinically node positive pre-operative
    Beskrivning

    Axillary lymph node group Positive Preoperative

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0729594
    UMLS CUI [1,2]
    C1446409
    UMLS CUI [1,3]
    C0445204
    bilateral breast cancer
    Beskrivning

    bilateral breast cancer

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0281267
    evidence of metastatic disease
    Beskrivning

    Metastatic Neoplasm

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2939420
    history of invasive breast cancer
    Beskrivning

    Invasive breast carcinoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0853879
    previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
    Beskrivning

    Prior Therapy Axilla | Operative Surgical Procedures | Therapeutic radiology procedure | Hidradenitis Suppurativa | Skin lesion | Melanocytic nevus

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0004454
    UMLS CUI [2]
    C0543467
    UMLS CUI [3]
    C1522449
    UMLS CUI [4]
    C0162836
    UMLS CUI [5]
    C0037284
    UMLS CUI [6]
    C0027962
    pregnant or nursing
    Beskrivning

    Pregnancy | Breast Feeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    other prior malignancies within the past 5 years (except successfully treated basal cell and squamous cell skin cancer, carcinoma in situ of the cervix or carcinoma in situ of the ipsilateral or contralateral breast) or unsuccessfully treated malignancies > 5 years before randomization
    Beskrivning

    Malignant Neoplasms Previous | Basal cell carcinoma | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix | Carcinoma in Situ Breast Ipsilateral | Carcinoma in Situ Breast Contralateral

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0205156
    UMLS CUI [2]
    C0007117
    UMLS CUI [3]
    C0553723
    UMLS CUI [4]
    C0851140
    UMLS CUI [5,1]
    C0007099
    UMLS CUI [5,2]
    C0006141
    UMLS CUI [5,3]
    C0441989
    UMLS CUI [6,1]
    C0007099
    UMLS CUI [6,2]
    C0006141
    UMLS CUI [6,3]
    C0441988
    unable or unwilling to give informed consent
    Beskrivning

    Unable Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1299582
    UMLS CUI [1,2]
    C0021430
    Tillbaka till toppen

    Similar models

    Eligibility Breast Neoplasms NCT02271828

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Gender
    Item
    female
    boolean
    C0079399 (UMLS CUI [1])
    Age
    Item
    aged 18 years or older
    boolean
    C0001779 (UMLS CUI [1])
    Invasive breast carcinoma
    Item
    pathologically confirmed invasive breast carcinoma
    boolean
    C0853879 (UMLS CUI [1])
    Tumor stage T1 | Tumor stage T2
    Item
    a clinical t1-2 tumor
    boolean
    C0475372 (UMLS CUI [1])
    C0475373 (UMLS CUI [2])
    Lumpectomy (breast cancer) | Whole breast Therapeutic radiology procedure
    Item
    will be treated with lumpectomy and whole breast radiotherapy
    boolean
    C0740370 (UMLS CUI [1])
    C0457102 (UMLS CUI [2,1])
    C1522449 (UMLS CUI [2,2])
    Clinically node negative (t1n0m0) or t2n0m0) invasive breast cancer | Axillary lymph node level Absence of signs Neoplasm Metastasis | Physical Examination | Ultrasonics (sound) Preoperative Axilla | Cytopathology finding Negative | Histopathology finding Negative
    Item
    clinically node negative status: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
    boolean
    C3248613 (UMLS CUI [1])
    C0441924 (UMLS CUI [2,1])
    C0277791 (UMLS CUI [2,2])
    C0027627 (UMLS CUI [2,3])
    C0031809 (UMLS CUI [3])
    C1456803 (UMLS CUI [4,1])
    C0445204 (UMLS CUI [4,2])
    C0004454 (UMLS CUI [4,3])
    C0456521 (UMLS CUI [5,1])
    C0205160 (UMLS CUI [5,2])
    C0428093 (UMLS CUI [6,1])
    C0205160 (UMLS CUI [6,2])
    Informed Consent
    Item
    written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Axillary lymph node group Positive Preoperative
    Item
    clinically node positive pre-operative
    boolean
    C0729594 (UMLS CUI [1,1])
    C1446409 (UMLS CUI [1,2])
    C0445204 (UMLS CUI [1,3])
    bilateral breast cancer
    Item
    bilateral breast cancer
    boolean
    C0281267 (UMLS CUI [1])
    Metastatic Neoplasm
    Item
    evidence of metastatic disease
    boolean
    C2939420 (UMLS CUI [1])
    Invasive breast carcinoma
    Item
    history of invasive breast cancer
    boolean
    C0853879 (UMLS CUI [1])
    Prior Therapy Axilla | Operative Surgical Procedures | Therapeutic radiology procedure | Hidradenitis Suppurativa | Skin lesion | Melanocytic nevus
    Item
    previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
    boolean
    C1514463 (UMLS CUI [1,1])
    C0004454 (UMLS CUI [1,2])
    C0543467 (UMLS CUI [2])
    C1522449 (UMLS CUI [3])
    C0162836 (UMLS CUI [4])
    C0037284 (UMLS CUI [5])
    C0027962 (UMLS CUI [6])
    Pregnancy | Breast Feeding
    Item
    pregnant or nursing
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Malignant Neoplasms Previous | Basal cell carcinoma | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix | Carcinoma in Situ Breast Ipsilateral | Carcinoma in Situ Breast Contralateral
    Item
    other prior malignancies within the past 5 years (except successfully treated basal cell and squamous cell skin cancer, carcinoma in situ of the cervix or carcinoma in situ of the ipsilateral or contralateral breast) or unsuccessfully treated malignancies > 5 years before randomization
    boolean
    C0006826 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    C0007117 (UMLS CUI [2])
    C0553723 (UMLS CUI [3])
    C0851140 (UMLS CUI [4])
    C0007099 (UMLS CUI [5,1])
    C0006141 (UMLS CUI [5,2])
    C0441989 (UMLS CUI [5,3])
    C0007099 (UMLS CUI [6,1])
    C0006141 (UMLS CUI [6,2])
    C0441988 (UMLS CUI [6,3])
    Unable Informed Consent
    Item
    unable or unwilling to give informed consent
    boolean
    C1299582 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
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