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ID

16250

Beschreibung

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

Stichworte

  1. 07.07.16 07.07.16 -
Hochgeladen am

7. Juli 2016

DOI

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Lizenz

Creative Commons BY 4.0

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    Eligibility Breast Cancer NCT00162812

    Eligibility Breast Cancer NCT00162812

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

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

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0678222 (Breast Carcinoma)
    SNOMED
    254838004
    UMLS CUI [1,2]
    C0205188 (Operable)
    SNOMED
    76234009
    UMLS CUI [2]
    C3495949 (Locally advanced breast cancer)
    SNOMED
    1082701000112100
    UMLS CUI [3]
    C0278601 (Inflammatory Breast Carcinoma)
    SNOMED
    254840009
    2. age less than 70 years
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    3. female patient
    Beschreibung

    Gender

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    4. tumor size 2 cm at ultrasound examination.
    Beschreibung

    Tumor size | Ultrasound examination

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0475440 (Tumor size)
    SNOMED
    263605001
    UMLS CUI [2]
    C0948501 (Ultrasound examination)
    5. er-negative tumors defined according to immunohistochemistry (i.e. < 10% of positive cells after immunostaining).
    Beschreibung

    Estrogen receptor negative neoplasm | Immunohistochemistry | percent positive cells

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2584629 (Estrogen receptor negative neoplasm)
    SNOMED
    441117001
    UMLS CUI [2]
    C0021044 (Immunohistochemistry)
    SNOMED
    708097004
    UMLS CUI [3]
    C0439178 (percent positive cells)
    SNOMED
    258758003
    6. multifocal and multicentric breast tumors are allowed if all foci are er-negative.
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2986662 (Multifocal breast carcinoma)
    UMLS CUI [2]
    C2986664 (Multicentric Breast Carcinoma)
    UMLS CUI [3,1]
    C0205234 (Focal)
    SNOMED
    87017008
    LOINC
    LA26555-5
    UMLS CUI [3,2]
    C0279756 (Estrogen receptor negative)
    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).
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0677930 (Primary Neoplasm)
    UMLS CUI [1,2]
    C2827483 (Fixed Specimen)
    UMLS CUI [2,1]
    C0677930 (Primary Neoplasm)
    UMLS CUI [2,2]
    C1548793 (Specimen Condition -frozen)
    UMLS CUI [3]
    C0014582 (epirubicin)
    SNOMED
    349848009
    UMLS CUI [4,1]
    C0005516 (Biological Markers)
    UMLS CUI [4,2]
    C1261322 (Evaluation procedure)
    SNOMED
    129265001
    LOINC
    LA15395-9
    UMLS CUI [5]
    C1336657 (TOP2A gene)
    LOINC
    LP111482-8
    UMLS CUI [6]
    C0256022 (DNA topoisomerase II alpha)
    UMLS CUI [7]
    C0242957 (ERBB2 gene)
    LOINC
    LP36215-9
    UMLS CUI [8]
    C0079419 (TP53 gene)
    LOINC
    LP19769-6
    UMLS CUI [9]
    C0600597 (Oligonucleotide Arrays)
    8. written informed consent before study registration.
    Beschreibung

    Informed consent

    Datentyp

    boolean

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

    ECOG performance status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    10. normal cbc, hepatic and renal functions
    Beschreibung

    Complete Blood Count | Liver function | Renal function

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0009555 (Complete Blood Count)
    SNOMED
    26604007
    UMLS CUI [2]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    UMLS CUI [3]
    C0232804 (Renal function)
    SNOMED
    11953005
    LOINC
    LP31398-8
    11. normal left ventricular ejection fraction by echocardiography or muga scan
    Beschreibung

    Left ventricular ejection fraction | Echocardiography | Multiple gated acquisition scanning

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0428772 (Left ventricular ejection fraction)
    SNOMED
    250908004
    UMLS CUI [2]
    C0013516 (Echocardiography)
    SNOMED
    40701008
    LOINC
    LP6171-5
    UMLS CUI [3]
    C0521317 (Multiple gated acquisition scanning)
    SNOMED
    404221001
    LOINC
    LA11846-5
    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.
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118 (Childbearing Potential)
    UMLS CUI [1,2]
    C0427780 (Pregnancy test negative)
    SNOMED
    250425007
    UMLS CUI [2,1]
    C3831118 (Childbearing Potential)
    UMLS CUI [2,2]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    UMLS CUI [3]
    C2985296 (Hormonal Contraception)
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    1. metastatic breast cancer
    Beschreibung

    Carcinoma breast stage IV

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0278488 (Carcinoma breast stage IV)
    2. serious medical conditions like:
    Beschreibung

    medical condition Serious

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040 (Other medical condition)
    LOINC
    LA16346-1
    UMLS CUI [1,2]
    C0205404 (Serious)
    SNOMED
    42745003
    LOINC
    LA30751-4
    1. congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled arrhythmias.
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0018802 (Congestive heart failure)
    SNOMED
    42343007
    LOINC
    MTHU020787
    UMLS CUI [2]
    C0002965 (Angina, Unstable)
    SNOMED
    4557003
    UMLS CUI [3]
    C0027051 (Myocardial Infarction)
    SNOMED
    22298006
    UMLS CUI [4,1]
    C0003811 (Cardiac Arrhythmia)
    SNOMED
    698247007
    LOINC
    LA7414-1
    UMLS CUI [4,2]
    C0205318 (Uncontrolled)
    SNOMED
    19032002
    2. history of significant neurologic or psychiatric disorders
    Beschreibung

    nervous system disorder Significant | Mental disorders Significant

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0027765 (nervous system disorder)
    SNOMED
    118940003
    LOINC
    LA10590-0
    UMLS CUI [1,2]
    C0750502 (Significant)
    SNOMED
    386134007
    LOINC
    LA28474-7
    UMLS CUI [2,1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    UMLS CUI [2,2]
    C0750502 (Significant)
    SNOMED
    386134007
    LOINC
    LA28474-7
    3. active uncontrolled infection
    Beschreibung

    Communicable Diseases Uncontrolled

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    UMLS CUI [1,2]
    C0205318 (Uncontrolled)
    SNOMED
    19032002
    4. active peptic ulcer, unstable diabetes mellitus
    Beschreibung

    Peptic Ulcer | Brittle diabetes

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0030920 (Peptic Ulcer)
    SNOMED
    13200003
    UMLS CUI [2]
    C0342302 (Brittle diabetes)
    SNOMED
    11530004
    3. concomitant contralateral invasive breast cancer
    Beschreibung

    Contralateral breast cancer Invasive

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1096616 (Contralateral breast cancer)
    UMLS CUI [1,2]
    C0205281 (Invasive)
    SNOMED
    10179008
    LOINC
    LP102225-2
    4. concurrent treatment with hormonal replacement therapy
    Beschreibung

    Hormone replacement therapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0282402 (Hormone replacement therapy)
    SNOMED
    266717002
    5. concurrent treatment with any other anti-cancer therapy
    Beschreibung

    cancer treatment

    Datentyp

    boolean

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

    prior anthracycline therapy Breast Carcinoma

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0278941 (prior anthracycline therapy)
    UMLS CUI [1,2]
    C0678222 (Breast Carcinoma)
    SNOMED
    254838004

    Ähnliche Modelle

    Eligibility Breast Cancer NCT00162812

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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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