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ID

42032

Beschrijving

International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Registry Formular (Please send this to study centre until Day 8) Clinical Trial Number: NCT01117441.

Trefwoorden

Versies (2)
  1. 21-05-16 21-05-16 -
  2. 15-03-21 15-03-21 - Dr. rer. medic Philipp Neuhaus
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15 maart 2021

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Creative Commons BY-NC-ND 3.0
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    Registry Formular AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441

    Engels

    Registry Formular AIEOP-BFM ALL 2009 NCT01117441

    1 Formulieren  
    Patient Information
    Beschrijving

    Patient Information

    Alias
    UMLS CUI-1
    C1955348
    Patient name
    Beschrijving

    Patient name

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1299487
    Patient Birth Date
    Beschrijving

    Patient Birth Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0421451
    Patient's gender
    Beschrijving

    Gender

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0079399
    Date of diagnosis
    Beschrijving

    Date of diagnosis

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2316983
    Therapy start date (start of pre-phase)
    Beschrijving

    Therapy start date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C3173309
    Eligibility Criteria
    Beschrijving

    Eligibility Criteria

    Alias
    UMLS CUI-1
    C0013893
    Diagnosis of primary ALL
    Beschrijving

    Diagnosis of primary ALL

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0023449
    UMLS CUI [1,2]
    C0011900
    Exclusion of BCR/ABL-rearrangement or translocation t(9;22)?
    Beschrijving

    BCR/ABL-rearrangement or t(9;22)

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0004891
    UMLS CUI [2]
    C3897138
    Exclusion of pregnancy or nursing?
    Beschrijving

    Pregnancy or nursing

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    Does patient participate in another study trial? (Except for associated studies)
    Beschrijving

    Study Participation status

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    Informed consent given by person who has custody of child (if patient > 15 y/o, informed consent given by patient himself/ herself) to participate in study and data storage
    Beschrijving

    Informed consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Did patient receive steroids (longer than 2 weeks; dosage >= 1 mg/kg/d) or cytostatics 4 weeks before diagnosis?
    Beschrijving

    Steroid therapy and chemotherapy regimen

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0149783
    UMLS CUI [2]
    C0392920
    Does the patient has any comorbidity which is interferring with study protocol?
    Beschrijving

    Comorbidity affecting study protocol

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C2348563
    If Patient received steroid therapy (longer than 2 weeks; dosage >= 1 mg/kg/d) or cytostatics 4 weeks before diagnosis, specify:
    Beschrijving

    If Patient received steroid therapy (longer than 2 weeks; dosage >= 1 mg/kg/d) or cytostatics 4 weeks before diagnosis, specify:

    Alias
    UMLS CUI-1
    C0149783
    UMLS CUI-2
    C0392920
    Specify steroid therapy and chemotherapy regimen:
    Beschrijving

    Steroid therapy and chemotherapy regimen: Specification

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0149783
    UMLS CUI [1,2]
    C2348235
    UMLS CUI [2,1]
    C0392920
    UMLS CUI [2,2]
    C2348235
    Specify received daily dose:
    Beschrijving

    Daily Dose

    Datatype

    float

    Alias
    UMLS CUI [1]
    C2348070
    Specify start date of therapy:
    Beschrijving

    Start date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0808070
    Specify last date of therapy:
    Beschrijving

    End date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0806020
    Informed consent to participate in Concomitant studies and for storage of clinical samples
    Beschrijving

    Informed consent to participate in Concomitant studies and for storage of clinical samples

    Alias
    UMLS CUI-1
    C0021430
    UMLS CUI-2
    C0521115
    UMLS CUI-3
    C0008976
    UMLS CUI-5
    C0021430
    UMLS CUI-6
    C3242025
    Early diagnosis of high risk patient for relapse?
    Beschrijving

    High risk for relapse

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0684030
    UMLS CUI [1,2]
    C0277556
    Moleculargenetic evidence of minimal CNS leukemia?
    Beschrijving

    CNS leukemia

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1332884
    Diagnostic meaning of IL-15 in CNS-leukemia?
    Beschrijving

    IL-15 and CNS leukemia

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0254610
    UMLS CUI [1,2]
    C1332884
    Genetic change in leukemic cells and its prognostic meaning?
    Beschrijving

    Genetic change in leukemic cells

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1517806
    UMLS CUI [1,2]
    C1705285
    Genetic variation as risk factors for severe infections (during chemotherapy)?
    Beschrijving

    Genetic variation as risk factors for infections

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1705285
    UMLS CUI [1,2]
    C0035648
    UMLS CUI [1,3]
    C0009450
    Storage of clinical samples for future trials about leukemia?
    Beschrijving

    Storage of clinical samples: Leukemia trials

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C3242025
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0023418
    Storage of clinical samples for future trials about host cells -target?
    Beschrijving

    Storage of clinical samples: host cells -target- trials

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C3242025
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C1819995
    UMLS CUI [1,4]
    C1521840
    Storage of clinical samples for future trials about host cells -whole genom?
    Beschrijving

    Storage of clinical samples: host cells -whole genom- trials

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C3242025
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C1819995
    UMLS CUI [1,4]
    C2350277
    Laboratory Diagnostic
    Beschrijving

    Laboratory Diagnostic

    Alias
    UMLS CUI-1
    C1254361
    Immunologic tests
    Beschrijving

    Immunologic tests

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0021061
    If immunologic tests were performed in not-referrence laboratory, specify:
    Beschrijving

    Immunologic tests: Specification

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0021061
    UMLS CUI [1,2]
    C2348235
    Karyotypization and Moleculargenetics (RT-PCR, FISH for diagnosis of TEL/AML1, BCR/ABL, MLL-Rearrangements, others)
    Beschrijving

    Karyotypization and Moleculargenetics

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0022526
    UMLS CUI [2]
    C1948182
    If Karyotypization and Moleculargenetics were performed, specify laboratory:
    Beschrijving

    Karyotypization and Moleculargenetics: Specification

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0022526
    UMLS CUI [1,2]
    C2348235
    UMLS CUI [2,1]
    C1948182
    UMLS CUI [2,2]
    C2348235
    Identification and Signature
    Beschrijving

    Identification and Signature

    Alias
    UMLS CUI-1
    C0205396
    UMLS CUI-2
    C1519316
    Doctor's Name
    Beschrijving

    Doctor's Name

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0027365
    UMLS CUI [1,2]
    C0031831
    Date of report
    Beschrijving

    Date of report

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1302584
    Doctor's signature
    Beschrijving

    Signature

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1519316
    Terug naar het begin van de pagina

    Similar models

    Registry Formular AIEOP-BFM ALL 2009 NCT01117441

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Patient Information
    C1955348 (UMLS CUI-1)
    Patient name
    Item
    Patient name
    text
    C1299487 (UMLS CUI [1])
    Patient Birth Date
    Item
    Patient Birth Date
    date
    C0421451 (UMLS CUI [1])
    Item
    Patient's gender
    text
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Patient's gender
    CL Item
    Male (Male)
    CL Item
    Female (Female)
    Date of diagnosis
    Item
    Date of diagnosis
    date
    C2316983 (UMLS CUI [1])
    Therapy start date
    Item
    Therapy start date (start of pre-phase)
    date
    C3173309 (UMLS CUI [1])
    Item Group
    Eligibility Criteria
    C0013893 (UMLS CUI-1)
    Diagnosis of primary ALL
    Item
    Diagnosis of primary ALL
    boolean
    C0023449 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    BCR/ABL-rearrangement or t(9;22)
    Item
    Exclusion of BCR/ABL-rearrangement or translocation t(9;22)?
    boolean
    C0004891 (UMLS CUI [1])
    C3897138 (UMLS CUI [2])
    Pregnancy or nursing
    Item
    Exclusion of pregnancy or nursing?
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Study Participation status
    Item
    Does patient participate in another study trial? (Except for associated studies)
    boolean
    C2348568 (UMLS CUI [1])
    Informed consent
    Item
    Informed consent given by person who has custody of child (if patient > 15 y/o, informed consent given by patient himself/ herself) to participate in study and data storage
    boolean
    C0021430 (UMLS CUI [1])
    Steroid therapy and chemotherapy regimen
    Item
    Did patient receive steroids (longer than 2 weeks; dosage >= 1 mg/kg/d) or cytostatics 4 weeks before diagnosis?
    boolean
    C0149783 (UMLS CUI [1])
    C0392920 (UMLS CUI [2])
    Comorbidity affecting study protocol
    Item
    Does the patient has any comorbidity which is interferring with study protocol?
    boolean
    C0009488 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C2348563 (UMLS CUI [1,3])
    Item Group
    If Patient received steroid therapy (longer than 2 weeks; dosage >= 1 mg/kg/d) or cytostatics 4 weeks before diagnosis, specify:
    C0149783 (UMLS CUI-1)
    C0392920 (UMLS CUI-2)
    Steroid therapy and chemotherapy regimen: Specification
    Item
    Specify steroid therapy and chemotherapy regimen:
    text
    C0149783 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    C0392920 (UMLS CUI [2,1])
    C2348235 (UMLS CUI [2,2])
    Daily Dose
    Item
    Specify received daily dose:
    float
    C2348070 (UMLS CUI [1])
    Start date
    Item
    Specify start date of therapy:
    date
    C0808070 (UMLS CUI [1])
    End date
    Item
    Specify last date of therapy:
    date
    C0806020 (UMLS CUI [1])
    Item Group
    Informed consent to participate in Concomitant studies and for storage of clinical samples
    C0021430 (UMLS CUI-1)
    C0521115 (UMLS CUI-2)
    C0008976 (UMLS CUI-3)
    C0021430 (UMLS CUI-5)
    C3242025 (UMLS CUI-6)
    High risk for relapse
    Item
    Early diagnosis of high risk patient for relapse?
    boolean
    C0684030 (UMLS CUI [1,1])
    C0277556 (UMLS CUI [1,2])
    CNS leukemia
    Item
    Moleculargenetic evidence of minimal CNS leukemia?
    boolean
    C1332884 (UMLS CUI [1])
    IL-15 and CNS leukemia
    Item
    Diagnostic meaning of IL-15 in CNS-leukemia?
    boolean
    C0254610 (UMLS CUI [1,1])
    C1332884 (UMLS CUI [1,2])
    Genetic change in leukemic cells
    Item
    Genetic change in leukemic cells and its prognostic meaning?
    boolean
    C1517806 (UMLS CUI [1,1])
    C1705285 (UMLS CUI [1,2])
    Genetic variation as risk factors for infections
    Item
    Genetic variation as risk factors for severe infections (during chemotherapy)?
    boolean
    C1705285 (UMLS CUI [1,1])
    C0035648 (UMLS CUI [1,2])
    C0009450 (UMLS CUI [1,3])
    Storage of clinical samples: Leukemia trials
    Item
    Storage of clinical samples for future trials about leukemia?
    boolean
    C3242025 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0023418 (UMLS CUI [1,3])
    Storage of clinical samples: host cells -target- trials
    Item
    Storage of clinical samples for future trials about host cells -target?
    boolean
    C3242025 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C1819995 (UMLS CUI [1,3])
    C1521840 (UMLS CUI [1,4])
    Storage of clinical samples: host cells -whole genom- trials
    Item
    Storage of clinical samples for future trials about host cells -whole genom?
    boolean
    C3242025 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C1819995 (UMLS CUI [1,3])
    C2350277 (UMLS CUI [1,4])
    Item Group
    Laboratory Diagnostic
    C1254361 (UMLS CUI-1)
    Item
    Immunologic tests
    text
    C0021061 (UMLS CUI [1])
    Immunologic tests
    Code List
    Immunologic tests
    CL Item
    Not performed (Not performed)
    CL Item
    Performed: in referrence laboratory (Berlin-Buch, Prof. Ludwig) (Performed: in referrence laboratory (Berlin-Buch, Prof. Ludwig))
    CL Item
    Performed: not in referrence laboratory (Performed: not in referrence laboratory)
    Immunologic tests: Specification
    Item
    If immunologic tests were performed in not-referrence laboratory, specify:
    text
    C0021061 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item
    Karyotypization and Moleculargenetics (RT-PCR, FISH for diagnosis of TEL/AML1, BCR/ABL, MLL-Rearrangements, others)
    text
    C0022526 (UMLS CUI [1])
    C1948182 (UMLS CUI [2])
    Karyotypization and Moleculargenetics
    Code List
    Karyotypization and Moleculargenetics (RT-PCR, FISH for diagnosis of TEL/AML1, BCR/ABL, MLL-Rearrangements, others)
    CL Item
    Not performed (Not performed)
    CL Item
    Performed: in referrence laboratory (Performed: in referrence laboratory )
    CL Item
    Performed: not in referrence laboratory (Performed: not in referrence laboratory)
    Karyotypization and Moleculargenetics: Specification
    Item
    If Karyotypization and Moleculargenetics were performed, specify laboratory:
    text
    C0022526 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    C1948182 (UMLS CUI [2,1])
    C2348235 (UMLS CUI [2,2])
    Item Group
    Identification and Signature
    C0205396 (UMLS CUI-1)
    C1519316 (UMLS CUI-2)
    Doctor's Name
    Item
    Doctor's Name
    text
    C0027365 (UMLS CUI [1,1])
    C0031831 (UMLS CUI [1,2])
    Date of report
    Item
    Date of report
    date
    C1302584 (UMLS CUI [1])
    Signature
    Item
    Doctor's signature
    text
    C1519316 (UMLS CUI [1])
    Terug naar het begin van de pagina 

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