ID

20193

Description

Radiation Therapy in Treating Women With Early-Stage Breast Cancer Who Have Undergone Breast Conservation Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00814567

Link

https://clinicaltrials.gov/show/NCT00814567

Keywords

Versions (1)
  1. 2/11/17 2/11/17 -
Uploaded on

February 11, 2017

DOI

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License

Creative Commons BY 4.0
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    Eligibility Breast Cancer NCT00814567

    English

    Eligibility Breast Cancer NCT00814567

    1 forms  
    Criteria
    Description

    Criteria

    Alias
    UMLS CUI-1
    C0242801
    diagnosis of low-risk early stage breast cancer, meeting the following criteria:
    Description

    Low-risk early stage breast cancer

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2986665
    UMLS CUI [1,2]
    C3538919
    invasive adenocarcinoma
    Description

    Invasive adenocarcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0853879
    no invasive carcinoma of classical lobular type
    Description

    Invasive Lobular Breast Carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0279565
    no lymphovascular invasion
    Description

    Lymphovascular invasion

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1708790
    tumor size pathologically determined to be ≤ 3.0 cm in diameter (pt1-2) (< 3.1 cm maximum microscopic diameter of invasive component)
    Description

    Tumor size

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0475440
    unifocal disease
    Description

    Unifocal disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1710542
    grade i, ii, or iii disease
    Description

    Grading

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0919553
    axillary lymph nodes negative (pn0)
    Description

    Axillary lymph nodes

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0729594
    sentinel lymph node biopsy and isolated tumor cells < 0.2 mm allowed
    Description

    Sentinel lymph node

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0796693
    must have undergone breast conservation surgery with or without adjuvant systemic therapy
    Description

    Breast-Conserving Surgery

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0917927
    minimum microscopic margin of non-cancerous tissue ≥ 2 mm (excluding deep margin if this is at deep fascia)
    Description

    Tumor margin status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1269830
    at low risk of local recurrence after radiotherapy (< 1% annual risk local recurrence)
    Description

    Recurrence Risk

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2986492
    no prior mastectomy
    Description

    Mastectomy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0024881
    no blood-borne metastases
    Description

    Hematogen metastases

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1700301
    UMLS CUI [1,2]
    C0027627
    patient characteristics:
    Description

    Patient characteristics

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0815172
    no prior malignancy except nonmelanoma skin cancer
    Description

    Prior malignancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2735088
    prior concurrent therapy:
    Description

    Concurrent therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009429
    see disease characteristics
    Description

    Disease characteristics

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1705348
    no prior endocrine therapy or chemotherapy
    Description

    Endocrine therapy or chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0279025
    UMLS CUI [2]
    C0392920
    neoadjuvant endocrine therapy allowed provided the tumour is < 3.0 cm and all other inclusion criteria are met
    Description

    Neoadjuvant endocrine therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0600558
    UMLS CUI [1,2]
    C0279025
    no primary endocrine therapy as a replacement for surgery
    Description

    Primary endocrine therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1708063
    UMLS CUI [1,2]
    C0279025
    no concurrent chemoradiotherapy
    Description

    Concurrent chemoradiotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3178775
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    Similar models

    Eligibility Breast Cancer NCT00814567

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Criteria
    C0242801 (UMLS CUI-1)
    Low-risk early stage breast cancer
    Item
    diagnosis of low-risk early stage breast cancer, meeting the following criteria:
    boolean
    C2986665 (UMLS CUI [1,1])
    C3538919 (UMLS CUI [1,2])
    Invasive adenocarcinoma
    Item
    invasive adenocarcinoma
    boolean
    C0853879 (UMLS CUI [1])
    Invasive Lobular Breast Carcinoma
    Item
    no invasive carcinoma of classical lobular type
    boolean
    C0279565 (UMLS CUI [1])
    Lymphovascular invasion
    Item
    no lymphovascular invasion
    boolean
    C1708790 (UMLS CUI [1])
    Tumor size
    Item
    tumor size pathologically determined to be ≤ 3.0 cm in diameter (pt1-2) (< 3.1 cm maximum microscopic diameter of invasive component)
    boolean
    C0475440 (UMLS CUI [1])
    Unifocal disease
    Item
    unifocal disease
    boolean
    C1710542 (UMLS CUI [1])
    Grading
    Item
    grade i, ii, or iii disease
    boolean
    C0919553 (UMLS CUI [1])
    Axillary lymph nodes
    Item
    axillary lymph nodes negative (pn0)
    boolean
    C0729594 (UMLS CUI [1])
    Sentinel lymph node
    Item
    sentinel lymph node biopsy and isolated tumor cells < 0.2 mm allowed
    boolean
    C0796693 (UMLS CUI [1])
    Breast-Conserving Surgery
    Item
    must have undergone breast conservation surgery with or without adjuvant systemic therapy
    boolean
    C0917927 (UMLS CUI [1])
    Tumor margin status
    Item
    minimum microscopic margin of non-cancerous tissue ≥ 2 mm (excluding deep margin if this is at deep fascia)
    boolean
    C1269830 (UMLS CUI [1])
    Recurrence Risk
    Item
    at low risk of local recurrence after radiotherapy (< 1% annual risk local recurrence)
    boolean
    C2986492 (UMLS CUI [1])
    Mastectomy
    Item
    no prior mastectomy
    boolean
    C0024881 (UMLS CUI [1])
    Hematogen metastases
    Item
    no blood-borne metastases
    boolean
    C1700301 (UMLS CUI [1,1])
    C0027627 (UMLS CUI [1,2])
    Patient characteristics
    Item
    patient characteristics:
    boolean
    C0815172 (UMLS CUI [1])
    Prior malignancy
    Item
    no prior malignancy except nonmelanoma skin cancer
    boolean
    C2735088 (UMLS CUI [1])
    Concurrent therapy
    Item
    prior concurrent therapy:
    boolean
    C0009429 (UMLS CUI [1])
    Disease characteristics
    Item
    see disease characteristics
    boolean
    C1705348 (UMLS CUI [1])
    Endocrine therapy or chemotherapy
    Item
    no prior endocrine therapy or chemotherapy
    boolean
    C0279025 (UMLS CUI [1])
    C0392920 (UMLS CUI [2])
    Neoadjuvant endocrine therapy
    Item
    neoadjuvant endocrine therapy allowed provided the tumour is < 3.0 cm and all other inclusion criteria are met
    boolean
    C0600558 (UMLS CUI [1,1])
    C0279025 (UMLS CUI [1,2])
    Primary endocrine therapy
    Item
    no primary endocrine therapy as a replacement for surgery
    boolean
    C1708063 (UMLS CUI [1,1])
    C0279025 (UMLS CUI [1,2])
    Concurrent chemoradiotherapy
    Item
    no concurrent chemoradiotherapy
    boolean
    C3178775 (UMLS CUI [1])
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