ID

16250

Description

Topoisomerase II Alpha Gene Amplification and Protein Overexpression Predicting Efficacy of Epirubicin; ODM derived from: https://clinicaltrials.gov/show/NCT00162812

Link

https://clinicaltrials.gov/show/NCT00162812

Keywords

  1. 7/7/16 7/7/16 -
Uploaded on

July 7, 2016

DOI

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License

Creative Commons BY 4.0

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    Eligibility Breast Cancer NCT00162812

    Eligibility Breast Cancer NCT00162812

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. histologically-confirmed breast cancer (operable, locally advanced or inflammatory)
    Description

    Breast Carcinoma Operable | Locally advanced breast cancer | Inflammatory Breast Carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0678222
    UMLS CUI [1,2]
    C0205188
    UMLS CUI [2]
    C3495949
    UMLS CUI [3]
    C0278601
    2. age less than 70 years
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    3. female patient
    Description

    Gender

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    4. tumor size 2 cm at ultrasound examination.
    Description

    Tumor size | Ultrasound examination

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0475440
    UMLS CUI [2]
    C0948501
    5. er-negative tumors defined according to immunohistochemistry (i.e. < 10% of positive cells after immunostaining).
    Description

    Estrogen receptor negative neoplasm | Immunohistochemistry | percent positive cells

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2584629
    UMLS CUI [2]
    C0021044
    UMLS CUI [3]
    C0439178
    6. multifocal and multicentric breast tumors are allowed if all foci are er-negative.
    Description

    Multifocal breast carcinoma | Multicentric Breast Carcinoma | Foci Estrogen receptor negative

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2986662
    UMLS CUI [2]
    C2986664
    UMLS CUI [3,1]
    C0205234
    UMLS CUI [3,2]
    C0279756
    7. fixed and frozen samples from the primary tumor, obtained before treatment with epirubicin, must be available for evaluation of biological markers (topo ii alpha gene and protein, her-2 gene, p-53 gene, oligonucleotides microarrays).
    Description

    primary tumor Fixed Specimen | primary tumor Frozen Specimen | Epirubicin | Biological Markers Evaluation | TOP2A gene | DNA topoisomerase II alpha | ERBB2 gene | TP53 gene | Oligonucleotide Arrays

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0677930
    UMLS CUI [1,2]
    C2827483
    UMLS CUI [2,1]
    C0677930
    UMLS CUI [2,2]
    C1548793
    UMLS CUI [3]
    C0014582
    UMLS CUI [4,1]
    C0005516
    UMLS CUI [4,2]
    C1261322
    UMLS CUI [5]
    C1336657
    UMLS CUI [6]
    C0256022
    UMLS CUI [7]
    C0242957
    UMLS CUI [8]
    C0079419
    UMLS CUI [9]
    C0600597
    8. written informed consent before study registration.
    Description

    Informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    9. performance status 0 or 1 (ecog scale)
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    10. normal cbc, hepatic and renal functions
    Description

    Complete Blood Count | Liver function | Renal function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009555
    UMLS CUI [2]
    C0232741
    UMLS CUI [3]
    C0232804
    11. normal left ventricular ejection fraction by echocardiography or muga scan
    Description

    Left ventricular ejection fraction | Echocardiography | Multiple gated acquisition scanning

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0428772
    UMLS CUI [2]
    C0013516
    UMLS CUI [3]
    C0521317
    12. negative pregnancy test for all women of childbearing potential. patients of childbearing potential must implement adequate non-hormonal measures to avoid pregnancy during treatment.
    Description

    Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Hormonal contraception

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0427780
    UMLS CUI [2,1]
    C3831118
    UMLS CUI [2,2]
    C0700589
    UMLS CUI [3]
    C2985296
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. metastatic breast cancer
    Description

    Carcinoma breast stage IV

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0278488
    2. serious medical conditions like:
    Description

    medical condition Serious

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0205404
    1. congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled arrhythmias.
    Description

    Congestive heart failure | Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia Uncontrolled

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0018802
    UMLS CUI [2]
    C0002965
    UMLS CUI [3]
    C0027051
    UMLS CUI [4,1]
    C0003811
    UMLS CUI [4,2]
    C0205318
    2. history of significant neurologic or psychiatric disorders
    Description

    nervous system disorder Significant | Mental disorders Significant

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0027765
    UMLS CUI [1,2]
    C0750502
    UMLS CUI [2,1]
    C0004936
    UMLS CUI [2,2]
    C0750502
    3. active uncontrolled infection
    Description

    Communicable Diseases Uncontrolled

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205318
    4. active peptic ulcer, unstable diabetes mellitus
    Description

    Peptic Ulcer | Brittle diabetes

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0030920
    UMLS CUI [2]
    C0342302
    3. concomitant contralateral invasive breast cancer
    Description

    Contralateral breast cancer Invasive

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1096616
    UMLS CUI [1,2]
    C0205281
    4. concurrent treatment with hormonal replacement therapy
    Description

    Hormone replacement therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0282402
    5. concurrent treatment with any other anti-cancer therapy
    Description

    cancer treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0920425
    6. previous treatment with anthracyclines for breast cancer
    Description

    prior anthracycline therapy Breast Carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0278941
    UMLS CUI [1,2]
    C0678222

    Similar models

    Eligibility Breast Cancer NCT00162812

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Breast Carcinoma Operable | Locally advanced breast cancer | Inflammatory Breast Carcinoma
    Item
    1. histologically-confirmed breast cancer (operable, locally advanced or inflammatory)
    boolean
    C0678222 (UMLS CUI [1,1])
    C0205188 (UMLS CUI [1,2])
    C3495949 (UMLS CUI [2])
    C0278601 (UMLS CUI [3])
    Age
    Item
    2. age less than 70 years
    boolean
    C0001779 (UMLS CUI [1])
    Gender
    Item
    3. female patient
    boolean
    C0079399 (UMLS CUI [1])
    Tumor size | Ultrasound examination
    Item
    4. tumor size 2 cm at ultrasound examination.
    boolean
    C0475440 (UMLS CUI [1])
    C0948501 (UMLS CUI [2])
    Estrogen receptor negative neoplasm | Immunohistochemistry | percent positive cells
    Item
    5. er-negative tumors defined according to immunohistochemistry (i.e. < 10% of positive cells after immunostaining).
    boolean
    C2584629 (UMLS CUI [1])
    C0021044 (UMLS CUI [2])
    C0439178 (UMLS CUI [3])
    Multifocal breast carcinoma | Multicentric Breast Carcinoma | Foci Estrogen receptor negative
    Item
    6. multifocal and multicentric breast tumors are allowed if all foci are er-negative.
    boolean
    C2986662 (UMLS CUI [1])
    C2986664 (UMLS CUI [2])
    C0205234 (UMLS CUI [3,1])
    C0279756 (UMLS CUI [3,2])
    primary tumor Fixed Specimen | primary tumor Frozen Specimen | Epirubicin | Biological Markers Evaluation | TOP2A gene | DNA topoisomerase II alpha | ERBB2 gene | TP53 gene | Oligonucleotide Arrays
    Item
    7. fixed and frozen samples from the primary tumor, obtained before treatment with epirubicin, must be available for evaluation of biological markers (topo ii alpha gene and protein, her-2 gene, p-53 gene, oligonucleotides microarrays).
    boolean
    C0677930 (UMLS CUI [1,1])
    C2827483 (UMLS CUI [1,2])
    C0677930 (UMLS CUI [2,1])
    C1548793 (UMLS CUI [2,2])
    C0014582 (UMLS CUI [3])
    C0005516 (UMLS CUI [4,1])
    C1261322 (UMLS CUI [4,2])
    C1336657 (UMLS CUI [5])
    C0256022 (UMLS CUI [6])
    C0242957 (UMLS CUI [7])
    C0079419 (UMLS CUI [8])
    C0600597 (UMLS CUI [9])
    Informed consent
    Item
    8. written informed consent before study registration.
    boolean
    C0021430 (UMLS CUI [1])
    ECOG performance status
    Item
    9. performance status 0 or 1 (ecog scale)
    boolean
    C1520224 (UMLS CUI [1])
    Complete Blood Count | Liver function | Renal function
    Item
    10. normal cbc, hepatic and renal functions
    boolean
    C0009555 (UMLS CUI [1])
    C0232741 (UMLS CUI [2])
    C0232804 (UMLS CUI [3])
    Left ventricular ejection fraction | Echocardiography | Multiple gated acquisition scanning
    Item
    11. normal left ventricular ejection fraction by echocardiography or muga scan
    boolean
    C0428772 (UMLS CUI [1])
    C0013516 (UMLS CUI [2])
    C0521317 (UMLS CUI [3])
    Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Hormonal contraception
    Item
    12. negative pregnancy test for all women of childbearing potential. patients of childbearing potential must implement adequate non-hormonal measures to avoid pregnancy during treatment.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0427780 (UMLS CUI [1,2])
    C3831118 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    C2985296 (UMLS CUI [3])
    Item Group
    C0680251 (UMLS CUI)
    Carcinoma breast stage IV
    Item
    1. metastatic breast cancer
    boolean
    C0278488 (UMLS CUI [1])
    medical condition Serious
    Item
    2. serious medical conditions like:
    boolean
    C3843040 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    Congestive heart failure | Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia Uncontrolled
    Item
    1. congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled arrhythmias.
    boolean
    C0018802 (UMLS CUI [1])
    C0002965 (UMLS CUI [2])
    C0027051 (UMLS CUI [3])
    C0003811 (UMLS CUI [4,1])
    C0205318 (UMLS CUI [4,2])
    nervous system disorder Significant | Mental disorders Significant
    Item
    2. history of significant neurologic or psychiatric disorders
    boolean
    C0027765 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    C0004936 (UMLS CUI [2,1])
    C0750502 (UMLS CUI [2,2])
    Communicable Diseases Uncontrolled
    Item
    3. active uncontrolled infection
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    Peptic Ulcer | Brittle diabetes
    Item
    4. active peptic ulcer, unstable diabetes mellitus
    boolean
    C0030920 (UMLS CUI [1])
    C0342302 (UMLS CUI [2])
    Contralateral breast cancer Invasive
    Item
    3. concomitant contralateral invasive breast cancer
    boolean
    C1096616 (UMLS CUI [1,1])
    C0205281 (UMLS CUI [1,2])
    Hormone replacement therapy
    Item
    4. concurrent treatment with hormonal replacement therapy
    boolean
    C0282402 (UMLS CUI [1])
    cancer treatment
    Item
    5. concurrent treatment with any other anti-cancer therapy
    boolean
    C0920425 (UMLS CUI [1])
    prior anthracycline therapy Breast Carcinoma
    Item
    6. previous treatment with anthracyclines for breast cancer
    boolean
    C0278941 (UMLS CUI [1,1])
    C0678222 (UMLS CUI [1,2])

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