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28334

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NCT02499003 The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

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  1. 30.11.17 30.11.17 -
  2. 04.01.18 04.01.18 -
Rechteinhaber

Prof. Dr. med. Georg Heß

Hochgeladen am

4. Januar 2018

DOI

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Creative Commons BY-NC 3.0
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    Screening Inclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

    Englisch

    Screening Inclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

    1 Formulare  
    Admininstrative data
    Beschreibung

    Admininstrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject ID
    Beschreibung

    Subject ID

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693 (Inclusion)
    1. Patients aged >=18 years
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    Trial Protocol Version 1.0: 2. CD20 positive disease
    Beschreibung

    Trial Protocol Version 2.0: Criterion 2 removed.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [1,2]
    C3888518 (CD20 antigen positive)
    3. Histologically proven diagnosis of diffuse large cell B-cell lymphoma, follicular lymphoma IIIB or transformed indolent lymphoma according to the World Health Organization classification (central pathology review)
    Beschreibung

    Diagnosis lymphoma

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    UMLS CUI [1,2]
    C0024299 (Lymphoma)
    SNOMED
    115244002
    LOINC
    LA15685-3
    4. Relapsed disease
    Beschreibung

    Relapsed disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0277556 (Recurrent disease)
    SNOMED
    58184002
    5. ECOG performance status =< 2, unless tumor associated
    Beschreibung

    ECOG performance status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    Trial protocol version 1.0: 6. LVEF >= 45% and normal serum troponin
    Beschreibung

    LVEF

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0428772 (Left ventricular ejection fraction)
    SNOMED
    250908004
    Trial protocol Version 2.0: 6. Adequate cardiac reserve
    Beschreibung

    Serum troponin level must be consistent with no significant acute or chronic myocardial damage and there should be no evidence of symptomatic disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0232164 (Cardiac function)
    SNOMED
    86185002
    UMLS CUI [1,2]
    C2347957 (Reservation (action))
    7. No curative option available
    Beschreibung

    cure no

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1880198 (Cure (remedy))
    UMLS CUI [1,2]
    C1298908 (no)
    SNOMED
    373067005
    8. At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration
    Beschreibung

    tumor mass

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3273930 (Tumor Mass)
    9. Signed informed consent
    Beschreibung

    informed consent signed

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0742766 (consent signed)
    10. Adequate bone marrow reserve / hepatic and renal function
    Beschreibung

    Adequate bone marrow reserve: - Platelets of at least 100.000/μl (in case of extensive BM-Infiltration 75.000/μl may be acceptable after discussion with the coordinating investigator); - absolute neutrophil count of at least 1000/μl . Adequate hepatic and renal function: - ALT < 2.5 x upper limit of normal (ULN); - AST < 2.5 x ULN; - total Bilirubin < 1.5 x ULN.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005953 (Bone Marrow)
    SNOMED
    279729006
    LOINC
    LP7410-6
    UMLS CUI [1,2]
    C2347957 (Reservation (action))
    UMLS CUI [1,3]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    UMLS CUI [1,4]
    C0232804 (Renal function)
    SNOMED
    11953005
    LOINC
    LP31398-8
    11. No active Hepatitis B or C or HIV-infection
    Beschreibung

    Hepatitis B Hepatitis C HIV-infection

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0019163 (Hepatitis B)
    SNOMED
    66071002
    LOINC
    LA18126-5
    UMLS CUI [1,2]
    C0019196 (Hepatitis C)
    SNOMED
    50711007
    LOINC
    LA19423-5
    UMLS CUI [1,3]
    C0019693 (HIV Infections)
    SNOMED
    86406008
    12. Measured or calculated creatinine clearance > 30 ml/min
    Beschreibung

    creatinine clearance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0812399 (Creatinine clearance)
    LOINC
    LP29651-4
    13. Fresh tumor biopsy or archived tissue available
    Beschreibung

    Fresh tumor biopsy

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0475358 (Tumor tissue sample)
    SNOMED
    258435002
    UMLS CUI [1,2]
    C0005558 (Biopsy)
    SNOMED
    129314006
    LOINC
    LP68311-7
    UMLS CUI [1,3]
    C2827486 (Fresh Specimen)
    14. Ability of patient to understand nature, importance and individual consequences of clinical trial
    Beschreibung

    compliance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    15. Women post-menopausal for more than two years can participate in the trial. Women with childbearing potential can only participate, if they are surgically sterile or a negative pregnancy test (Serum or Urine) is available before trial and they are willing to practice a highly effective and medically accepted contraception method during trial and for a period of 18 months post-treatment.
    Beschreibung

    Reliable contraception comprises systematic contraceptives (oral, implant, injection) or diaphragm / condoms /intrauterine devices (IUP) with spermicide.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118 (Childbearing Potential)
    UMLS CUI [1,2]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    UMLS CUI [1,3]
    C0232970 (Postmenopausal state)
    SNOMED
    76498008
    16. Male patients are advised to use contraceptive methods (preferably barrier) during treatment and for a period of 6 months post-treatment
    Beschreibung

    contraception male patients

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0086580 (Male Contraception)
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Screening Inclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Admininstrative data
    C1320722 (UMLS CUI-1)
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    Age
    Item
    1. Patients aged >=18 years
    boolean
    C0001779 (UMLS CUI [1])
    disease CD20 positive
    Item
    Trial Protocol Version 1.0: 2. CD20 positive disease
    boolean
    C0012634 (UMLS CUI [1,1])
    C3888518 (UMLS CUI [1,2])
    Diagnosis lymphoma
    Item
    3. Histologically proven diagnosis of diffuse large cell B-cell lymphoma, follicular lymphoma IIIB or transformed indolent lymphoma according to the World Health Organization classification (central pathology review)
    boolean
    C0011900 (UMLS CUI [1,1])
    C0024299 (UMLS CUI [1,2])
    Relapsed disease
    Item
    4. Relapsed disease
    boolean
    C0277556 (UMLS CUI [1])
    ECOG performance status
    Item
    5. ECOG performance status =< 2, unless tumor associated
    boolean
    C1520224 (UMLS CUI [1])
    LVEF
    Item
    Trial protocol version 1.0: 6. LVEF >= 45% and normal serum troponin
    boolean
    C0428772 (UMLS CUI [1])
    cardiac reserve
    Item
    Trial protocol Version 2.0: 6. Adequate cardiac reserve
    boolean
    C0232164 (UMLS CUI [1,1])
    C2347957 (UMLS CUI [1,2])
    cure no
    Item
    7. No curative option available
    boolean
    C1880198 (UMLS CUI [1,1])
    C1298908 (UMLS CUI [1,2])
    tumor mass
    Item
    8. At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration
    boolean
    C3273930 (UMLS CUI [1])
    informed consent signed
    Item
    9. Signed informed consent
    boolean
    C0742766 (UMLS CUI [1])
    bone marrow hepatic and renal function
    Item
    10. Adequate bone marrow reserve / hepatic and renal function
    boolean
    C0005953 (UMLS CUI [1,1])
    C2347957 (UMLS CUI [1,2])
    C0232741 (UMLS CUI [1,3])
    C0232804 (UMLS CUI [1,4])
    Hepatitis B Hepatitis C HIV-infection
    Item
    11. No active Hepatitis B or C or HIV-infection
    boolean
    C0019163 (UMLS CUI [1,1])
    C0019196 (UMLS CUI [1,2])
    C0019693 (UMLS CUI [1,3])
    creatinine clearance
    Item
    12. Measured or calculated creatinine clearance > 30 ml/min
    boolean
    C0812399 (UMLS CUI [1])
    Fresh tumor biopsy
    Item
    13. Fresh tumor biopsy or archived tissue available
    boolean
    C0475358 (UMLS CUI [1,1])
    C0005558 (UMLS CUI [1,2])
    C2827486 (UMLS CUI [1,3])
    compliance
    Item
    14. Ability of patient to understand nature, importance and individual consequences of clinical trial
    boolean
    C1321605 (UMLS CUI [1])
    childbearing potential post-menopausal
    Item
    15. Women post-menopausal for more than two years can participate in the trial. Women with childbearing potential can only participate, if they are surgically sterile or a negative pregnancy test (Serum or Urine) is available before trial and they are willing to practice a highly effective and medically accepted contraception method during trial and for a period of 18 months post-treatment.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C0232970 (UMLS CUI [1,3])
    contraception male patients
    Item
    16. Male patients are advised to use contraceptive methods (preferably barrier) during treatment and for a period of 6 months post-treatment
    boolean
    C0086580 (UMLS CUI [1])
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