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ID

16431

Beskrivning

Study in Women With Metastatic Breast Cancer Whose Cancer Has Gotten Worse After Anthracycline and Taxane Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00067314

Länk

https://clinicaltrials.gov/show/NCT00067314

Nyckelord

Versioner (1)
  1. 16.07.16 16.07.16 -
Uppladdad den

16. Juli 2016

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Breast Neoplasms NCT00067314

    Engelsk

    Eligibility Breast Neoplasms NCT00067314

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    locally advanced or metastatic breast cancer not amenable to surgery or radiation with curative intent
    Beskrivning

    Locally advanced breast cancer Amenable Operative Surgical Procedures | Carcinoma breast stage IV Amenable Operative Surgical Procedures | Locally advanced breast cancer Amenable Therapeutic radiology procedure Curative | Carcinoma breast stage IV Amenable Therapeutic radiology procedure Curative

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3495949 (Locally advanced breast cancer)
    SNOMED
    1082701000112100
    UMLS CUI [1,2]
    C3900053 (Amenable)
    UMLS CUI [1,3]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    UMLS CUI [2,1]
    C0278488 (Carcinoma breast stage IV)
    UMLS CUI [2,2]
    C3900053 (Amenable)
    UMLS CUI [2,3]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    UMLS CUI [3,1]
    C3495949 (Locally advanced breast cancer)
    SNOMED
    1082701000112100
    UMLS CUI [3,2]
    C3900053 (Amenable)
    UMLS CUI [3,3]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    UMLS CUI [3,4]
    C1276305 (Curative - procedure intent)
    SNOMED
    373808002
    UMLS CUI [4,1]
    C0278488 (Carcinoma breast stage IV)
    UMLS CUI [4,2]
    C3900053 (Amenable)
    UMLS CUI [4,3]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    UMLS CUI [4,4]
    C1276305 (Curative - procedure intent)
    SNOMED
    373808002
    must have received any chemotherapy regimen in the past
    Beskrivning

    Prior Chemotherapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1514457 (Prior Chemotherapy)
    evidence of tumor resistance to last chemotherapy defined as progression after 6 months of previous chemotherapy for advanced disease
    Beskrivning

    Chemotherapy Refractory cancer Evidence of | Disease Progression Status post Prior Chemotherapy Advanced cancer

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [1,2]
    C0677936 (Refractory cancer)
    UMLS CUI [1,3]
    C0332120 (Evidence of (contextual qualifier))
    SNOMED
    18669006
    UMLS CUI [2,1]
    C0242656 (Disease Progression)
    SNOMED
    246453008
    LOINC
    LP121764-7
    UMLS CUI [2,2]
    C0231290 (Status post)
    SNOMED
    237679004
    UMLS CUI [2,3]
    C1514457 (Prior Chemotherapy)
    UMLS CUI [2,4]
    C0877373 (Advanced cancer)
    must have measurable (by imaging techniques) disease
    Beskrivning

    Measurable Disease Imaging Techniques

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041 (Measurable Disease)
    UMLS CUI [1,2]
    C0079595 (Imaging Techniques)
    SNOMED
    278395004
    LOINC
    LP6328-1
    adequate bone marrow, liver and renal function
    Beskrivning

    Bone Marrow function | Liver function | Renal function

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005953 (Bone Marrow)
    SNOMED
    279729006
    LOINC
    LP7410-6
    UMLS CUI [1,2]
    C0031843 (physiological aspects)
    UMLS CUI [2]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    UMLS CUI [3]
    C0232804 (Renal function)
    SNOMED
    11953005
    LOINC
    LP31398-8
    must provide evidence of informed consent and willingness and ability to comply with scheduled visits, treatment plan and study procedures.
    Beskrivning

    Informed Consent | Compliance behavior Study Protocol

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    UMLS CUI [2,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [2,2]
    C2348563 (Study Protocol)
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    received more than 2 prior chemotherapy regimens for metastatic disease
    Beskrivning

    Prior Chemotherapy Quantity Carcinoma breast stage IV

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457 (Prior Chemotherapy)
    UMLS CUI [1,2]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    UMLS CUI [1,3]
    C0278488 (Carcinoma breast stage IV)
    received in the past another drug of the same class as the investigational drug, i.e. topoisomerase i inhibitor
    Beskrivning

    Pharmaceutical Preparation Class of Trial Agent Same | Topoisomerase I Inhibitors

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C2983595 (Class of Trial Agent)
    UMLS CUI [1,3]
    C0445247 (Same)
    SNOMED
    262126009
    LOINC
    LA11009-0
    UMLS CUI [2]
    C0594374 (Topoisomerase I Inhibitors)
    enrolled in another clinical intervention study
    Beskrivning

    Study Subject Participation Status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    pregnancy, breast feeding, fertile women refusing to use reliable contraceptive methods
    Beskrivning

    Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Refused

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    UMLS CUI [3,1]
    C3831118 (Childbearing Potential)
    UMLS CUI [3,2]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    UMLS CUI [3,3]
    C1705116 (Refused)
    SNOMED
    443390004
    LOINC
    LA4389-8
    cardiac or thrombotic event in the last 12 months
    Beskrivning

    cardiac event | Thrombotic disorder

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0741923 (cardiac event)
    UMLS CUI [2]
    C0040053 (Thrombosis)
    SNOMED
    118927008
    LOINC
    LP31622-1
    brain metastases
    Beskrivning

    Metastatic malignant neoplasm to brain

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0220650 (Metastatic malignant neoplasm to brain)
    SNOMED
    94225005
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    Similar models

    Eligibility Breast Neoplasms NCT00067314

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Locally advanced breast cancer Amenable Operative Surgical Procedures | Carcinoma breast stage IV Amenable Operative Surgical Procedures | Locally advanced breast cancer Amenable Therapeutic radiology procedure Curative | Carcinoma breast stage IV Amenable Therapeutic radiology procedure Curative
    Item
    locally advanced or metastatic breast cancer not amenable to surgery or radiation with curative intent
    boolean
    C3495949 (UMLS CUI [1,1])
    C3900053 (UMLS CUI [1,2])
    C0543467 (UMLS CUI [1,3])
    C0278488 (UMLS CUI [2,1])
    C3900053 (UMLS CUI [2,2])
    C0543467 (UMLS CUI [2,3])
    C3495949 (UMLS CUI [3,1])
    C3900053 (UMLS CUI [3,2])
    C1522449 (UMLS CUI [3,3])
    C1276305 (UMLS CUI [3,4])
    C0278488 (UMLS CUI [4,1])
    C3900053 (UMLS CUI [4,2])
    C1522449 (UMLS CUI [4,3])
    C1276305 (UMLS CUI [4,4])
    Prior Chemotherapy
    Item
    must have received any chemotherapy regimen in the past
    boolean
    C1514457 (UMLS CUI [1])
    Chemotherapy Refractory cancer Evidence of | Disease Progression Status post Prior Chemotherapy Advanced cancer
    Item
    evidence of tumor resistance to last chemotherapy defined as progression after 6 months of previous chemotherapy for advanced disease
    boolean
    C0392920 (UMLS CUI [1,1])
    C0677936 (UMLS CUI [1,2])
    C0332120 (UMLS CUI [1,3])
    C0242656 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
    C1514457 (UMLS CUI [2,3])
    C0877373 (UMLS CUI [2,4])
    Measurable Disease Imaging Techniques
    Item
    must have measurable (by imaging techniques) disease
    boolean
    C1513041 (UMLS CUI [1,1])
    C0079595 (UMLS CUI [1,2])
    Bone Marrow function | Liver function | Renal function
    Item
    adequate bone marrow, liver and renal function
    boolean
    C0005953 (UMLS CUI [1,1])
    C0031843 (UMLS CUI [1,2])
    C0232741 (UMLS CUI [2])
    C0232804 (UMLS CUI [3])
    Informed Consent | Compliance behavior Study Protocol
    Item
    must provide evidence of informed consent and willingness and ability to comply with scheduled visits, treatment plan and study procedures.
    boolean
    C0021430 (UMLS CUI [1])
    C1321605 (UMLS CUI [2,1])
    C2348563 (UMLS CUI [2,2])
    Item Group
    C0680251 (UMLS CUI)
    Prior Chemotherapy Quantity Carcinoma breast stage IV
    Item
    received more than 2 prior chemotherapy regimens for metastatic disease
    boolean
    C1514457 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C0278488 (UMLS CUI [1,3])
    Pharmaceutical Preparation Class of Trial Agent Same | Topoisomerase I Inhibitors
    Item
    received in the past another drug of the same class as the investigational drug, i.e. topoisomerase i inhibitor
    boolean
    C0013227 (UMLS CUI [1,1])
    C2983595 (UMLS CUI [1,2])
    C0445247 (UMLS CUI [1,3])
    C0594374 (UMLS CUI [2])
    Study Subject Participation Status
    Item
    enrolled in another clinical intervention study
    boolean
    C2348568 (UMLS CUI [1])
    Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Refused
    Item
    pregnancy, breast feeding, fertile women refusing to use reliable contraceptive methods
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C3831118 (UMLS CUI [3,1])
    C0700589 (UMLS CUI [3,2])
    C1705116 (UMLS CUI [3,3])
    cardiac event | Thrombotic disorder
    Item
    cardiac or thrombotic event in the last 12 months
    boolean
    C0741923 (UMLS CUI [1])
    C0040053 (UMLS CUI [2])
    Metastatic malignant neoplasm to brain
    Item
    brain metastases
    boolean
    C0220650 (UMLS CUI [1])
    Tillbaka till toppen 

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