ID

31532

Beschrijving

A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00944567

Link

https://clinicaltrials.gov/show/NCT00944567

Trefwoorden

Versies (1)
  1. 01-09-18 01-09-18 -
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See clinicaltrials.gov

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1 september 2018

DOI

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Creative Commons BY 4.0
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    Eligibility Primary Mediastinal B-Cell Lymphoma NCT00944567

    Engels

    Eligibility Primary Mediastinal B-Cell Lymphoma NCT00944567

    1 Formulieren  
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    primary mediastinal diffuse large b-cell lymphoma, cd20 positive. patients must have histological confirmation of the diagnosis, and in addition have a dominant mass within the anterior mediastinum.
    Beschrijving

    Mediastinal Large B-Cell Lymphoma CD20 positive | Mass Predominant Anterior mediastinum

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1292754
    UMLS CUI [1,2]
    C3888518
    UMLS CUI [2,1]
    C3273930
    UMLS CUI [2,2]
    C1542147
    UMLS CUI [2,3]
    C0230148
    no prior treatment of lymphoma. patients may have received corticosteroids for up to 1 week for the relief of local compressive symptoms.
    Beschrijving

    Prior Therapy Absent Lymphoma | Adrenal Cortex Hormones Symptoms Relief

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [1,3]
    C0024299
    UMLS CUI [2,1]
    C0001617
    UMLS CUI [2,2]
    C1457887
    UMLS CUI [2,3]
    C0564405
    any stage of disease.
    Beschrijving

    Disease Stage Any

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C1306673
    UMLS CUI [1,3]
    C1552551
    age at least 18 years.
    Beschrijving

    Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    fit to receive chemotherapy with curative intent.
    Beschrijving

    Fit Chemotherapy Curative intent

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0424576
    UMLS CUI [1,2]
    C0392920
    UMLS CUI [1,3]
    C1276305
    able and willing to give informed consent, and to undergo staging including pet scanning
    Beschrijving

    Informed Consent | Consent Staging | Consent Positron-Emission Tomography

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2,1]
    C1511481
    UMLS CUI [2,2]
    C0332305
    UMLS CUI [3,1]
    C1511481
    UMLS CUI [3,2]
    C0032743
    willingness to comply with an appropriate contraceptive method in women of childbearing potential or men.
    Beschrijving

    Childbearing Potential Contraceptive methods | Gender Contraceptive methods

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [2,1]
    C0079399
    UMLS CUI [2,2]
    C0700589
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry. cardiac compromise due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.
    Beschrijving

    Heart Disease | Ventricular arrhythmia Symptomatic | Congestive heart failure | Myocardial Infarction

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0018799
    UMLS CUI [2,1]
    C0085612
    UMLS CUI [2,2]
    C0231220
    UMLS CUI [3]
    C0018802
    UMLS CUI [4]
    C0027051
    impairment of bone marrow function (wbc <3.0x109/l, anc <1.5x109/l, plt <100x109/l), unless due to involvement by lymphoma.
    Beschrijving

    Bone Marrow function Impairment | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Exception Involvement with Lymphoma

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0005953
    UMLS CUI [1,2]
    C0031843
    UMLS CUI [1,3]
    C0221099
    UMLS CUI [2]
    C0023508
    UMLS CUI [3]
    C0948762
    UMLS CUI [4]
    C0032181
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C1314939
    UMLS CUI [5,3]
    C0024299
    major impairment of renal function (serum creatinine >2x upper normal) or liver function (asat/alat >2,5 upper normal, total bilirubin >2,5x upper normal), unless due to lymphoma involvement.
    Beschrijving

    Renal Insufficiency Major | Serum creatinine raised | Liver Dysfunction Major | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin | Exception Involvement with Lymphoma

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1565489
    UMLS CUI [1,2]
    C0205164
    UMLS CUI [2]
    C0700225
    UMLS CUI [3,1]
    C0086565
    UMLS CUI [3,2]
    C0205164
    UMLS CUI [4]
    C0151904
    UMLS CUI [5]
    C0151905
    UMLS CUI [6]
    C0741494
    UMLS CUI [7,1]
    C1705847
    UMLS CUI [7,2]
    C1314939
    UMLS CUI [7,3]
    C0024299
    known hiv infection. patients will not be tested routinely.
    Beschrijving

    HIV Infection

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    pregnant or lactating women.
    Beschrijving

    Pregnancy | Breast Feeding

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    Beschrijving

    Mental condition Interferes with Protocol Compliance | Condition Familial Interferes with Protocol Compliance | Sociological Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Protocol Compliance

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C3840291
    UMLS CUI [1,2]
    C0521102
    UMLS CUI [1,3]
    C0525058
    UMLS CUI [2,1]
    C0348080
    UMLS CUI [2,2]
    C0241888
    UMLS CUI [2,3]
    C0521102
    UMLS CUI [2,4]
    C0525058
    UMLS CUI [3,1]
    C3850138
    UMLS CUI [3,2]
    C0521102
    UMLS CUI [3,3]
    C0525058
    UMLS CUI [4,1]
    C0017444
    UMLS CUI [4,2]
    C0521102
    UMLS CUI [4,3]
    C0525058
    Terug naar het begin van de pagina

    Similar models

    Eligibility Primary Mediastinal B-Cell Lymphoma NCT00944567

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Mediastinal Large B-Cell Lymphoma CD20 positive | Mass Predominant Anterior mediastinum
    Item
    primary mediastinal diffuse large b-cell lymphoma, cd20 positive. patients must have histological confirmation of the diagnosis, and in addition have a dominant mass within the anterior mediastinum.
    boolean
    C1292754 (UMLS CUI [1,1])
    C3888518 (UMLS CUI [1,2])
    C3273930 (UMLS CUI [2,1])
    C1542147 (UMLS CUI [2,2])
    C0230148 (UMLS CUI [2,3])
    Prior Therapy Absent Lymphoma | Adrenal Cortex Hormones Symptoms Relief
    Item
    no prior treatment of lymphoma. patients may have received corticosteroids for up to 1 week for the relief of local compressive symptoms.
    boolean
    C1514463 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C0024299 (UMLS CUI [1,3])
    C0001617 (UMLS CUI [2,1])
    C1457887 (UMLS CUI [2,2])
    C0564405 (UMLS CUI [2,3])
    Disease Stage Any
    Item
    any stage of disease.
    boolean
    C0012634 (UMLS CUI [1,1])
    C1306673 (UMLS CUI [1,2])
    C1552551 (UMLS CUI [1,3])
    Age
    Item
    age at least 18 years.
    boolean
    C0001779 (UMLS CUI [1])
    Fit Chemotherapy Curative intent
    Item
    fit to receive chemotherapy with curative intent.
    boolean
    C0424576 (UMLS CUI [1,1])
    C0392920 (UMLS CUI [1,2])
    C1276305 (UMLS CUI [1,3])
    Informed Consent | Consent Staging | Consent Positron-Emission Tomography
    Item
    able and willing to give informed consent, and to undergo staging including pet scanning
    boolean
    C0021430 (UMLS CUI [1])
    C1511481 (UMLS CUI [2,1])
    C0332305 (UMLS CUI [2,2])
    C1511481 (UMLS CUI [3,1])
    C0032743 (UMLS CUI [3,2])
    Childbearing Potential Contraceptive methods | Gender Contraceptive methods
    Item
    willingness to comply with an appropriate contraceptive method in women of childbearing potential or men.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C0079399 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    Item Group
    C0680251 (UMLS CUI)
    Heart Disease | Ventricular arrhythmia Symptomatic | Congestive heart failure | Myocardial Infarction
    Item
    evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry. cardiac compromise due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.
    boolean
    C0018799 (UMLS CUI [1])
    C0085612 (UMLS CUI [2,1])
    C0231220 (UMLS CUI [2,2])
    C0018802 (UMLS CUI [3])
    C0027051 (UMLS CUI [4])
    Bone Marrow function Impairment | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Exception Involvement with Lymphoma
    Item
    impairment of bone marrow function (wbc <3.0x109/l, anc <1.5x109/l, plt <100x109/l), unless due to involvement by lymphoma.
    boolean
    C0005953 (UMLS CUI [1,1])
    C0031843 (UMLS CUI [1,2])
    C0221099 (UMLS CUI [1,3])
    C0023508 (UMLS CUI [2])
    C0948762 (UMLS CUI [3])
    C0032181 (UMLS CUI [4])
    C1705847 (UMLS CUI [5,1])
    C1314939 (UMLS CUI [5,2])
    C0024299 (UMLS CUI [5,3])
    Renal Insufficiency Major | Serum creatinine raised | Liver Dysfunction Major | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin | Exception Involvement with Lymphoma
    Item
    major impairment of renal function (serum creatinine >2x upper normal) or liver function (asat/alat >2,5 upper normal, total bilirubin >2,5x upper normal), unless due to lymphoma involvement.
    boolean
    C1565489 (UMLS CUI [1,1])
    C0205164 (UMLS CUI [1,2])
    C0700225 (UMLS CUI [2])
    C0086565 (UMLS CUI [3,1])
    C0205164 (UMLS CUI [3,2])
    C0151904 (UMLS CUI [4])
    C0151905 (UMLS CUI [5])
    C0741494 (UMLS CUI [6])
    C1705847 (UMLS CUI [7,1])
    C1314939 (UMLS CUI [7,2])
    C0024299 (UMLS CUI [7,3])
    HIV Infection
    Item
    known hiv infection. patients will not be tested routinely.
    boolean
    C0019693 (UMLS CUI [1])
    Pregnancy | Breast Feeding
    Item
    pregnant or lactating women.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Mental condition Interferes with Protocol Compliance | Condition Familial Interferes with Protocol Compliance | Sociological Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Protocol Compliance
    Item
    any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    boolean
    C3840291 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C0525058 (UMLS CUI [1,3])
    C0348080 (UMLS CUI [2,1])
    C0241888 (UMLS CUI [2,2])
    C0521102 (UMLS CUI [2,3])
    C0525058 (UMLS CUI [2,4])
    C3850138 (UMLS CUI [3,1])
    C0521102 (UMLS CUI [3,2])
    C0525058 (UMLS CUI [3,3])
    C0017444 (UMLS CUI [4,1])
    C0521102 (UMLS CUI [4,2])
    C0525058 (UMLS CUI [4,3])
    Terug naar het begin van de pagina 

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