0 Evaluaciones
ID

18452

Descripción

Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients With Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00073723

Link

https://clinicaltrials.gov/show/NCT00073723

Palabras clave

Versiones (1)
  1. 6/11/16 6/11/16 -
Subido en

6 de noviembre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Non-Small Cell Lung Cancer NCT00073723

    Inglés

    Eligibility Non-Small Cell Lung Cancer NCT00073723

    1 formularios  
    Criteria
    Descripción

    Criteria

    histologically or cytologically confirmed advanced stage iv nsclc with evidence of inoperable local recurrence or metastasis
    Descripción

    Non-Small Cell Lung Carcinoma Advanced | TNM clinical staging | Neoplasm Metastasis Recurrence Local Inoperable Evidence of

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0007131 (Non-Small Cell Lung Carcinoma)
    SNOMED
    254637007
    UMLS CUI [1,2]
    C0205179 (Advanced phase)
    SNOMED
    86005002
    UMLS CUI [2]
    C3258246 (TNM clinical staging)
    LOINC
    LP130437-9
    UMLS CUI [3,1]
    C0027627 (Neoplasm Metastasis)
    LOINC
    LP35033-7
    UMLS CUI [3,2]
    C2825055 (Recurrence (disease attribute))
    UMLS CUI [3,3]
    C0205276 (Local)
    SNOMED
    255470001
    LOINC
    LA4583-6
    UMLS CUI [3,4]
    C0205187 (Inoperable)
    SNOMED
    74778001
    UMLS CUI [3,5]
    C0332120 (Evidence of (contextual qualifier))
    SNOMED
    18669006
    if female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method
    Descripción

    Pregnancy | Breast Feeding | Serum pregnancy test negative | Childbearing Potential | Contraceptive methods

    Tipo de datos

    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]
    C0430061 (Serum pregnancy test negative)
    SNOMED
    166435006
    UMLS CUI [4]
    C3831118 (Childbearing Potential)
    UMLS CUI [5]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    eighteen years of age or older
    Descripción

    Age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    no other current active malignancy
    Descripción

    Malignant Neoplasms

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    measurable disease (defined by recist criteria) documented radiographically
    Descripción

    Measurable Disease | Radiography

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1513041 (Measurable Disease)
    UMLS CUI [2]
    C0034571 (roentgenographic)
    patient must have received no prior chemotherapies for the treatment of metastatic disease. radiation therapy to a major bone marrow-containing area must have been completed 3 or more weeks prior to study entry. prior treatment with egf-targeted therapies is permitted.
    Descripción

    Prior Chemotherapy Neoplasm Metastasis | Therapeutic radiology procedure Completed Bone Marrow Area Major | Epidermal Growth Factor Targeted Therapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457 (Prior Chemotherapy)
    UMLS CUI [1,2]
    C0027627 (Neoplasm Metastasis)
    LOINC
    LP35033-7
    UMLS CUI [2,1]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    UMLS CUI [2,2]
    C0205197 (Complete)
    SNOMED
    255594003
    LOINC
    LA13937-0
    UMLS CUI [2,3]
    C0005953 (Bone Marrow)
    SNOMED
    279729006
    LOINC
    LP7410-6
    UMLS CUI [2,4]
    C0205146 (Area)
    SNOMED
    42798000
    LOINC
    LP72094-3
    UMLS CUI [2,5]
    C0205164 (Major)
    SNOMED
    255603008
    LOINC
    LA29634-5
    UMLS CUI [3,1]
    C0242275 (epidermal growth factor)
    SNOMED
    259616001
    UMLS CUI [3,2]
    C2985566 (Targeted Therapy)
    if, at baseline, patient has anc greater than or equal to 1.5 x 109 cells/l; platelets greater than or equal to 100 x 109 cells/l and hgb greater than or equal to 9 g/dl
    Descripción

    Absolute neutrophil count | Platelet Count measurement | Hemoglobin

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0948762 (Absolute neutrophil count)
    UMLS CUI [2]
    C0032181 (Platelet Count measurement)
    SNOMED
    61928009
    UMLS CUI [3]
    C0019046 (Hemoglobin)
    SNOMED
    38082009
    LOINC
    LP32067-8
    if, at baseline, patient has ast and alt of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin normal; creatinine levels less than or equal to 1.5 mg/dl and alkaline phosphatase levels less than or equal to 2.5 x the upper limit of normal range (unless alkaline phosphatase elevation is felt to be related to bone metastases and there is no radiologic evidence of hepatic metastasis)
    Descripción

    Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Bilirubin total normal | Creatinine measurement, serum | Alkaline phosphatase measurement | Alkaline phosphatase raised Related Secondary malignant neoplasm of bone | Secondary malignant neoplasm of liver Evidence Radiologic

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0201899 (Aspartate aminotransferase measurement)
    SNOMED
    45896001
    UMLS CUI [2]
    C0201836 (Alanine aminotransferase measurement)
    SNOMED
    34608000
    UMLS CUI [3]
    C0860928 (Bilirubin total normal)
    UMLS CUI [4]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    UMLS CUI [5]
    C0201850 (Alkaline phosphatase measurement)
    SNOMED
    88810008
    UMLS CUI [6,1]
    C0151849 (Alkaline phosphatase raised)
    SNOMED
    274770006
    UMLS CUI [6,2]
    C0439849 (Relationships)
    SNOMED
    263498003
    LOINC
    LP146886-9
    UMLS CUI [6,3]
    C0153690 (Secondary malignant neoplasm of bone)
    SNOMED
    94222008
    UMLS CUI [7,1]
    C0494165 (Secondary malignant neoplasm of liver)
    SNOMED
    94381002
    UMLS CUI [7,2]
    C3887511 (Evidence)
    UMLS CUI [7,3]
    C0205483 (Radiologic)
    SNOMED
    5526005
    expected survival of greater than 12 weeks
    Descripción

    Continuance of life Expected

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0038952 (Continuance of life)
    UMLS CUI [1,2]
    C1517001 (Expected (qualifier))
    ecog performance status 0-1 (karnofsky > 70)
    Descripción

    ECOG performance status | Karnofsky Performance Status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    UMLS CUI [2]
    C0206065 (Karnofsky Performance Status)
    SNOMED
    273546003
    LOINC
    LP267177-6
    patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the informed consent form prior to participation in any study-related activities.
    Descripción

    Informed Consent | Informed Consent Patient Representative | Informed Consent Legal Guardian

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    UMLS CUI [2,1]
    C0021430 (Informed Consent)
    UMLS CUI [2,2]
    C0030701 (Patient Representatives)
    UMLS CUI [3,1]
    C0021430 (Informed Consent)
    UMLS CUI [3,2]
    C0023226 (Legal Guardians)
    SNOMED
    58626002
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    Similar models

    Eligibility Non-Small Cell Lung Cancer NCT00073723

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Non-Small Cell Lung Carcinoma Advanced | TNM clinical staging | Neoplasm Metastasis Recurrence Local Inoperable Evidence of
    Item
    histologically or cytologically confirmed advanced stage iv nsclc with evidence of inoperable local recurrence or metastasis
    boolean
    C0007131 (UMLS CUI [1,1])
    C0205179 (UMLS CUI [1,2])
    C3258246 (UMLS CUI [2])
    C0027627 (UMLS CUI [3,1])
    C2825055 (UMLS CUI [3,2])
    C0205276 (UMLS CUI [3,3])
    C0205187 (UMLS CUI [3,4])
    C0332120 (UMLS CUI [3,5])
    Pregnancy | Breast Feeding | Serum pregnancy test negative | Childbearing Potential | Contraceptive methods
    Item
    if female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0430061 (UMLS CUI [3])
    C3831118 (UMLS CUI [4])
    C0700589 (UMLS CUI [5])
    Age
    Item
    eighteen years of age or older
    boolean
    C0001779 (UMLS CUI [1])
    Malignant Neoplasms
    Item
    no other current active malignancy
    boolean
    C0006826 (UMLS CUI [1])
    Measurable Disease | Radiography
    Item
    measurable disease (defined by recist criteria) documented radiographically
    boolean
    C1513041 (UMLS CUI [1])
    C0034571 (UMLS CUI [2])
    Prior Chemotherapy Neoplasm Metastasis | Therapeutic radiology procedure Completed Bone Marrow Area Major | Epidermal Growth Factor Targeted Therapy
    Item
    patient must have received no prior chemotherapies for the treatment of metastatic disease. radiation therapy to a major bone marrow-containing area must have been completed 3 or more weeks prior to study entry. prior treatment with egf-targeted therapies is permitted.
    boolean
    C1514457 (UMLS CUI [1,1])
    C0027627 (UMLS CUI [1,2])
    C1522449 (UMLS CUI [2,1])
    C0205197 (UMLS CUI [2,2])
    C0005953 (UMLS CUI [2,3])
    C0205146 (UMLS CUI [2,4])
    C0205164 (UMLS CUI [2,5])
    C0242275 (UMLS CUI [3,1])
    C2985566 (UMLS CUI [3,2])
    Absolute neutrophil count | Platelet Count measurement | Hemoglobin
    Item
    if, at baseline, patient has anc greater than or equal to 1.5 x 109 cells/l; platelets greater than or equal to 100 x 109 cells/l and hgb greater than or equal to 9 g/dl
    boolean
    C0948762 (UMLS CUI [1])
    C0032181 (UMLS CUI [2])
    C0019046 (UMLS CUI [3])
    Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Bilirubin total normal | Creatinine measurement, serum | Alkaline phosphatase measurement | Alkaline phosphatase raised Related Secondary malignant neoplasm of bone | Secondary malignant neoplasm of liver Evidence Radiologic
    Item
    if, at baseline, patient has ast and alt of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin normal; creatinine levels less than or equal to 1.5 mg/dl and alkaline phosphatase levels less than or equal to 2.5 x the upper limit of normal range (unless alkaline phosphatase elevation is felt to be related to bone metastases and there is no radiologic evidence of hepatic metastasis)
    boolean
    C0201899 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    C0860928 (UMLS CUI [3])
    C0201976 (UMLS CUI [4])
    C0201850 (UMLS CUI [5])
    C0151849 (UMLS CUI [6,1])
    C0439849 (UMLS CUI [6,2])
    C0153690 (UMLS CUI [6,3])
    C0494165 (UMLS CUI [7,1])
    C3887511 (UMLS CUI [7,2])
    C0205483 (UMLS CUI [7,3])
    Continuance of life Expected
    Item
    expected survival of greater than 12 weeks
    boolean
    C0038952 (UMLS CUI [1,1])
    C1517001 (UMLS CUI [1,2])
    ECOG performance status | Karnofsky Performance Status
    Item
    ecog performance status 0-1 (karnofsky > 70)
    boolean
    C1520224 (UMLS CUI [1])
    C0206065 (UMLS CUI [2])
    Informed Consent | Informed Consent Patient Representative | Informed Consent Legal Guardian
    Item
    patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the informed consent form prior to participation in any study-related activities.
    boolean
    C0021430 (UMLS CUI [1])
    C0021430 (UMLS CUI [2,1])
    C0030701 (UMLS CUI [2,2])
    C0021430 (UMLS CUI [3,1])
    C0023226 (UMLS CUI [3,2])
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