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ID

14880

Description

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

Link

https://clinicaltrials.gov/show/NCT02271828

Keywords

Versions (1)
  1. 5/3/16 5/3/16 -
Uploaded on

May 3, 2016

DOI

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Creative Commons BY 4.0
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    Eligibility Breast Neoplasms NCT02271828

    English

    Eligibility Breast Neoplasms NCT02271828

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    female
    Description

    Gender

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    aged 18 years or older
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    pathologically confirmed invasive breast carcinoma
    Description

    Invasive breast carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0853879 (Invasive carcinoma of breast)
    SNOMED
    713609000
    a clinical t1-2 tumor
    Description

    Tumor stage T1 | Tumor stage T2

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0475372 (Tumor stage T1)
    SNOMED
    23351008
    LOINC
    LA3637-1
    UMLS CUI [2]
    C0475373 (Tumor stage T2)
    SNOMED
    67673008
    LOINC
    LA3628-0
    will be treated with lumpectomy and whole breast radiotherapy
    Description

    Lumpectomy (breast cancer) | Whole breast Therapeutic radiology procedure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0740370 (Lumpectomy (breast cancer))
    UMLS CUI [2,1]
    C0457102 (Whole breast)
    SNOMED
    277912007
    UMLS CUI [2,2]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    clinically node negative status: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
    Description

    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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3248613 (Clinically node negative (t1n0m0 or t2n0m0) invasive breast cancer)
    UMLS CUI [2,1]
    C0441924 (Axillary lymph node level)
    SNOMED
    258312001
    UMLS CUI [2,2]
    C0277791 (Absence of signs)
    SNOMED
    86631001
    UMLS CUI [2,3]
    C0027627 (Neoplasm Metastasis)
    LOINC
    LP35033-7
    UMLS CUI [3]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [4,1]
    C1456803 (Ultrasonics (sound))
    UMLS CUI [4,2]
    C0445204 (Preoperative)
    SNOMED
    262068006
    LOINC
    LP91296-1
    UMLS CUI [4,3]
    C0004454 (Axilla)
    SNOMED
    422543003
    LOINC
    LP7044-3
    UMLS CUI [5,1]
    C0456521 (Cytopathology finding)
    SNOMED
    277194006
    UMLS CUI [5,2]
    C0205160 (Negative)
    SNOMED
    260385009
    LOINC
    LP20719-8
    UMLS CUI [6,1]
    C0428093 (Histopathology finding)
    SNOMED
    250537006
    UMLS CUI [6,2]
    C0205160 (Negative)
    SNOMED
    260385009
    LOINC
    LP20719-8
    written informed consent
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    clinically node positive pre-operative
    Description

    Axillary lymph node group Positive Preoperative

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0729594 (Axillary lymph node group)
    SNOMED
    68171009
    UMLS CUI [1,2]
    C1446409 (Positive)
    SNOMED
    10828004
    UMLS CUI [1,3]
    C0445204 (Preoperative)
    SNOMED
    262068006
    LOINC
    LP91296-1
    bilateral breast cancer
    Description

    bilateral breast cancer

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0281267 (bilateral breast cancer)
    evidence of metastatic disease
    Description

    Metastatic Neoplasm

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2939420 (Metastatic Neoplasm)
    history of invasive breast cancer
    Description

    Invasive breast carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0853879 (Invasive carcinoma of breast)
    SNOMED
    713609000
    previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463 (Prior Therapy)
    UMLS CUI [1,2]
    C0004454 (Axilla)
    SNOMED
    422543003
    LOINC
    LP7044-3
    UMLS CUI [2]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    UMLS CUI [3]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    UMLS CUI [4]
    C0162836 (Hidradenitis Suppurativa)
    SNOMED
    59393003
    UMLS CUI [5]
    C0037284 (Skin lesion)
    SNOMED
    95324001
    UMLS CUI [6]
    C0027962 (Melanocytic nevus)
    SNOMED
    21119008
    pregnant or nursing
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    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
    Description

    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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [1,2]
    C0205156 (Previous)
    SNOMED
    9130008
    LOINC
    LP21061-4
    UMLS CUI [2]
    C0007117 (Basal cell carcinoma)
    SNOMED
    1338007
    UMLS CUI [3]
    C0553723 (Squamous cell carcinoma of skin)
    SNOMED
    254651007
    UMLS CUI [4]
    C0851140 (Carcinoma in situ of uterine cervix)
    SNOMED
    92564006
    UMLS CUI [5,1]
    C0007099 (Carcinoma in Situ)
    SNOMED
    109355002
    UMLS CUI [5,2]
    C0006141 (Breast)
    SNOMED
    76752008
    LOINC
    LP29849-4
    UMLS CUI [5,3]
    C0441989 (Ipsilateral)
    SNOMED
    255208005
    UMLS CUI [6,1]
    C0007099 (Carcinoma in Situ)
    SNOMED
    109355002
    UMLS CUI [6,2]
    C0006141 (Breast)
    SNOMED
    76752008
    LOINC
    LP29849-4
    UMLS CUI [6,3]
    C0441988 (Contralateral)
    SNOMED
    255209002
    unable or unwilling to give informed consent
    Description

    Unable Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1299582 (Unable)
    SNOMED
    371151008
    LOINC
    LA13868-7
    UMLS CUI [1,2]
    C0021430 (Informed Consent)
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    Similar models

    Eligibility Breast Neoplasms NCT02271828

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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