ID

14769

Beskrivning

PRospective Study to Measure the Impact of MammaPrint on Adjuvant Treatment in Hormone Receptor-positive HER2-negative Breast Cancer Patients (PRIMe); ODM derived from: https://clinicaltrials.gov/show/NCT02269813

Länk

https://clinicaltrials.gov/show/NCT02269813

Nyckelord

  1. 2016-04-27 2016-04-27 -
Uppladdad den

27 april 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Breast Cancer NCT02269813

    Eligibility Breast Cancer NCT02269813

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    women with histologically proven invasive stage 1 and 2 breast cancer
    Beskrivning

    Gender | Invasive breast carcinoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0853879
    hormone receptor positive according to local standards
    Beskrivning

    Hormone Receptor Positive

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0019929
    UMLS CUI [1,2]
    C1446409
    her2 negative - i.e. ihc 0-1+, or fish or other ish non-amplified (locally assessed)
    Beskrivning

    Human epidermal growth factor 2 negative carcinoma of breast | Immunohistochemistry | Fluorescent in Situ Hybridization

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2316304
    UMLS CUI [2]
    C0021044
    UMLS CUI [3]
    C0162789
    axillary lymph node status: 0-3 involved (macro metastases i.e. >2mm or micro metastases i.e. >0.2-2mm)
    Beskrivning

    axillary lymph node Status | Macrometastasis | Neoplasm Micrometastasis

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1279048
    UMLS CUI [1,2]
    C0449438
    UMLS CUI [2]
    C3829229
    UMLS CUI [3]
    C1513276
    ≥ 18 years of age at time of consent
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    patients must be eligible to receive adjuvant chemotherapy and endocrine therapy as defined by a good karnofsky index, no hematological, cardiological or hepatic contraindications nor any impeding comorbidity
    Beskrivning

    eligible Adjuvant Chemotherapy Hormone Therapy | Karnofsky Performance Status | Medical contraindication Hematological Disease Heart Diseases Liver diseases | Comorbidity

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1548635
    UMLS CUI [1,2]
    C0085533
    UMLS CUI [1,3]
    C0279025
    UMLS CUI [2]
    C0206065
    UMLS CUI [3,1]
    C1301624
    UMLS CUI [3,2]
    C0018939
    UMLS CUI [3,3]
    C0018799
    UMLS CUI [3,4]
    C0023895
    UMLS CUI [4]
    C0009488
    written informed consent
    Beskrivning

    Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    ≥4 involved axillary nodes
    Beskrivning

    Axillary lymph node group

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0729594
    multi-centric disease with more than 2 clinically relevant lesions
    Beskrivning

    Multicentric Breast Carcinoma Lesion

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2986664
    UMLS CUI [1,2]
    C0221198
    hr negative or her2 positive/amplified (locally assessed)
    Beskrivning

    Hormone Receptor Negative | HER2-positive carcinoma of breast

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0019929
    UMLS CUI [1,2]
    C0205160
    UMLS CUI [2]
    C1960398
    previous diagnosis of malignancy unless disease free for 10 years
    Beskrivning

    Prior diagnosis Malignant Neoplasms

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0332132
    UMLS CUI [1,2]
    C0006826
    metastatic disease
    Beskrivning

    Neoplasm Metastasis

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0027627
    tumor sample shipped to agendia with ≤ 30% tumor cells or that fails qa or qc criteria
    Beskrivning

    Tumor tissue sample | quality assurance | quality control

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0475358
    UMLS CUI [2]
    C0178932
    UMLS CUI [3]
    C0034378
    women who have started or completed adjuvant chemotherapy or neo-adjuvant chemotherapy for current breast cancer
    Beskrivning

    Gender | Adjuvant Chemotherapy Breast Carcinoma | Neoadjuvant Therapy Breast Carcinoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2,1]
    C0085533
    UMLS CUI [2,2]
    C0678222
    UMLS CUI [3,1]
    C0600558
    UMLS CUI [3,2]
    C0678222

    Similar models

    Eligibility Breast Cancer NCT02269813

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Gender | Invasive breast carcinoma
    Item
    women with histologically proven invasive stage 1 and 2 breast cancer
    boolean
    C0079399 (UMLS CUI [1])
    C0853879 (UMLS CUI [2])
    Hormone Receptor Positive
    Item
    hormone receptor positive according to local standards
    boolean
    C0019929 (UMLS CUI [1,1])
    C1446409 (UMLS CUI [1,2])
    Human epidermal growth factor 2 negative carcinoma of breast | Immunohistochemistry | Fluorescent in Situ Hybridization
    Item
    her2 negative - i.e. ihc 0-1+, or fish or other ish non-amplified (locally assessed)
    boolean
    C2316304 (UMLS CUI [1])
    C0021044 (UMLS CUI [2])
    C0162789 (UMLS CUI [3])
    axillary lymph node Status | Macrometastasis | Neoplasm Micrometastasis
    Item
    axillary lymph node status: 0-3 involved (macro metastases i.e. >2mm or micro metastases i.e. >0.2-2mm)
    boolean
    C1279048 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    C3829229 (UMLS CUI [2])
    C1513276 (UMLS CUI [3])
    Age
    Item
    ≥ 18 years of age at time of consent
    boolean
    C0001779 (UMLS CUI [1])
    eligible Adjuvant Chemotherapy Hormone Therapy | Karnofsky Performance Status | Medical contraindication Hematological Disease Heart Diseases Liver diseases | Comorbidity
    Item
    patients must be eligible to receive adjuvant chemotherapy and endocrine therapy as defined by a good karnofsky index, no hematological, cardiological or hepatic contraindications nor any impeding comorbidity
    boolean
    C1548635 (UMLS CUI [1,1])
    C0085533 (UMLS CUI [1,2])
    C0279025 (UMLS CUI [1,3])
    C0206065 (UMLS CUI [2])
    C1301624 (UMLS CUI [3,1])
    C0018939 (UMLS CUI [3,2])
    C0018799 (UMLS CUI [3,3])
    C0023895 (UMLS CUI [3,4])
    C0009488 (UMLS CUI [4])
    Informed Consent
    Item
    written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Axillary lymph node group
    Item
    ≥4 involved axillary nodes
    boolean
    C0729594 (UMLS CUI [1])
    Multicentric Breast Carcinoma Lesion
    Item
    multi-centric disease with more than 2 clinically relevant lesions
    boolean
    C2986664 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    Hormone Receptor Negative | HER2-positive carcinoma of breast
    Item
    hr negative or her2 positive/amplified (locally assessed)
    boolean
    C0019929 (UMLS CUI [1,1])
    C0205160 (UMLS CUI [1,2])
    C1960398 (UMLS CUI [2])
    Prior diagnosis Malignant Neoplasms
    Item
    previous diagnosis of malignancy unless disease free for 10 years
    boolean
    C0332132 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    Neoplasm Metastasis
    Item
    metastatic disease
    boolean
    C0027627 (UMLS CUI [1])
    Tumor tissue sample | quality assurance | quality control
    Item
    tumor sample shipped to agendia with ≤ 30% tumor cells or that fails qa or qc criteria
    boolean
    C0475358 (UMLS CUI [1])
    C0178932 (UMLS CUI [2])
    C0034378 (UMLS CUI [3])
    Gender | Adjuvant Chemotherapy Breast Carcinoma | Neoadjuvant Therapy Breast Carcinoma
    Item
    women who have started or completed adjuvant chemotherapy or neo-adjuvant chemotherapy for current breast cancer
    boolean
    C0079399 (UMLS CUI [1])
    C0085533 (UMLS CUI [2,1])
    C0678222 (UMLS CUI [2,2])
    C0600558 (UMLS CUI [3,1])
    C0678222 (UMLS CUI [3,2])

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