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ID

27753

Descripción

Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2008; ODM derived from: https://clinicaltrials.gov/show/NCT01953770

Link

https://clinicaltrials.gov/show/NCT01953770

Palabras clave

Versiones (1)
  1. 28/11/17 28/11/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

28 de noviembre de 2017

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Childhood Acute Lymphoblastic Leukemia NCT01953770

    Inglés

    Eligibility Childhood Acute Lymphoblastic Leukemia NCT01953770

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. age at diagnosis at 1 to 18 years.
    Descripción

    Age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. the start of induction therapy within a time interval of study recruitment phase.
    Descripción

    Induction Therapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0600558
    3. the diagnosis of all is to be proved by the morphological, cytochemical, and immunological analysis of tumor cells in bone marrow.
    Descripción

    Acute lymphocytic leukemia | Bone marrow tumor cells Analysis morphological | Bone marrow tumor cells Cytochemical test | Bone marrow tumor cells Immunologic analysis

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0023449
    UMLS CUI [2,1]
    C0238805
    UMLS CUI [2,2]
    C0002778
    UMLS CUI [2,3]
    C0543482
    UMLS CUI [3,1]
    C0238805
    UMLS CUI [3,2]
    C0201825
    UMLS CUI [4,1]
    C0238805
    UMLS CUI [4,2]
    C3516449
    4. informed consent of the parents (guardians) of the patient to be treated in one of the clinics included in this multicenter study.
    Descripción

    Informed Consent Parent | Informed Consent Guardian

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0030551
    UMLS CUI [2,1]
    C0021430
    UMLS CUI [2,2]
    C1274041
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. all is a second malignant tumor;
    Descripción

    Acute lymphocytic leukemia Second malignancy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0023449
    UMLS CUI [1,2]
    C0085183
    2. the disease is a relapse of previously misdiagnosed and, therefore, inadequately treated all;
    Descripción

    Recurrent disease | Acute lymphocytic leukemia Misdiagnosis | Acute lymphocytic leukemia Treated Inadequate

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0277556
    UMLS CUI [2,1]
    C0023449
    UMLS CUI [2,2]
    C0679838
    UMLS CUI [3,1]
    C0023449
    UMLS CUI [3,2]
    C1522326
    UMLS CUI [3,3]
    C0205412
    3. there is severe concomitant disease, which significantly impedes chemotherapy protocol (such as multiple malformations, heart diseases, metabolic disorders, etc.);
    Descripción

    Comorbidity Severe Preventing Chemotherapy Regimen | Multiple system malformation syndrome | Heart Diseases | Metabolic Diseases

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C1292733
    UMLS CUI [1,4]
    C0392920
    UMLS CUI [2]
    C0265198
    UMLS CUI [3]
    C0018799
    UMLS CUI [4]
    C0025517
    4. there is a lack of important basic data needed for the exact adherence to the cytostatic therapy according to a specific protocol of chemotherapy (differential diagnosis of acute lymphoblastic/myeloid leukemia is not possible, stratification according to risk group is not possible);
    Descripción

    Cytostatic chemotherapy | Data Basic Lacking | Acute lymphocytic leukemia Differential Diagnosis Unsuccessful | Acute Myelocytic Leukemia Differential Diagnosis Unsuccessful | Risk Group Stratification Unsuccessful

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2609342
    UMLS CUI [2,1]
    C1511726
    UMLS CUI [2,2]
    C1527178
    UMLS CUI [2,3]
    C0332268
    UMLS CUI [3,1]
    C0023449
    UMLS CUI [3,2]
    C0011906
    UMLS CUI [3,3]
    C1272705
    UMLS CUI [4,1]
    C0023467
    UMLS CUI [4,2]
    C0011906
    UMLS CUI [4,3]
    C1272705
    UMLS CUI [5,1]
    C0035647
    UMLS CUI [5,2]
    C0441833
    UMLS CUI [5,3]
    C1514983
    UMLS CUI [5,4]
    C1272705
    5. the patient was treated before for a long time with cytotoxic drugs;
    Descripción

    Cytotoxic agent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0304497
    6. there were deviations in the treatment not covered by the protocol and/or not due to side effects of treatment and/or complications of the disease
    Descripción

    Therapeutic procedure Protocol Deviation | Therapeutic procedure Deviation Independent of Adverse effects | Therapeutic procedure Deviation Independent of Disease complication

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C1705236
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0205419
    UMLS CUI [2,3]
    C0332291
    UMLS CUI [2,4]
    C0879626
    UMLS CUI [3,1]
    C0087111
    UMLS CUI [3,2]
    C0205419
    UMLS CUI [3,3]
    C0332291
    UMLS CUI [3,4]
    C0544688
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    Eligibility Childhood Acute Lymphoblastic Leukemia NCT01953770

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    1. age at diagnosis at 1 to 18 years.
    boolean
    C0001779 (UMLS CUI [1])
    Induction Therapy
    Item
    2. the start of induction therapy within a time interval of study recruitment phase.
    boolean
    C0600558 (UMLS CUI [1])
    Acute lymphocytic leukemia | Bone marrow tumor cells Analysis morphological | Bone marrow tumor cells Cytochemical test | Bone marrow tumor cells Immunologic analysis
    Item
    3. the diagnosis of all is to be proved by the morphological, cytochemical, and immunological analysis of tumor cells in bone marrow.
    boolean
    C0023449 (UMLS CUI [1])
    C0238805 (UMLS CUI [2,1])
    C0002778 (UMLS CUI [2,2])
    C0543482 (UMLS CUI [2,3])
    C0238805 (UMLS CUI [3,1])
    C0201825 (UMLS CUI [3,2])
    C0238805 (UMLS CUI [4,1])
    C3516449 (UMLS CUI [4,2])
    Informed Consent Parent | Informed Consent Guardian
    Item
    4. informed consent of the parents (guardians) of the patient to be treated in one of the clinics included in this multicenter study.
    boolean
    C0021430 (UMLS CUI [1,1])
    C0030551 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [2,1])
    C1274041 (UMLS CUI [2,2])
    Item Group
    C0680251 (UMLS CUI)
    Acute lymphocytic leukemia Second malignancy
    Item
    1. all is a second malignant tumor;
    boolean
    C0023449 (UMLS CUI [1,1])
    C0085183 (UMLS CUI [1,2])
    Recurrent disease | Acute lymphocytic leukemia Misdiagnosis | Acute lymphocytic leukemia Treated Inadequate
    Item
    2. the disease is a relapse of previously misdiagnosed and, therefore, inadequately treated all;
    boolean
    C0277556 (UMLS CUI [1])
    C0023449 (UMLS CUI [2,1])
    C0679838 (UMLS CUI [2,2])
    C0023449 (UMLS CUI [3,1])
    C1522326 (UMLS CUI [3,2])
    C0205412 (UMLS CUI [3,3])
    Comorbidity Severe Preventing Chemotherapy Regimen | Multiple system malformation syndrome | Heart Diseases | Metabolic Diseases
    Item
    3. there is severe concomitant disease, which significantly impedes chemotherapy protocol (such as multiple malformations, heart diseases, metabolic disorders, etc.);
    boolean
    C0009488 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C1292733 (UMLS CUI [1,3])
    C0392920 (UMLS CUI [1,4])
    C0265198 (UMLS CUI [2])
    C0018799 (UMLS CUI [3])
    C0025517 (UMLS CUI [4])
    Cytostatic chemotherapy | Data Basic Lacking | Acute lymphocytic leukemia Differential Diagnosis Unsuccessful | Acute Myelocytic Leukemia Differential Diagnosis Unsuccessful | Risk Group Stratification Unsuccessful
    Item
    4. there is a lack of important basic data needed for the exact adherence to the cytostatic therapy according to a specific protocol of chemotherapy (differential diagnosis of acute lymphoblastic/myeloid leukemia is not possible, stratification according to risk group is not possible);
    boolean
    C2609342 (UMLS CUI [1])
    C1511726 (UMLS CUI [2,1])
    C1527178 (UMLS CUI [2,2])
    C0332268 (UMLS CUI [2,3])
    C0023449 (UMLS CUI [3,1])
    C0011906 (UMLS CUI [3,2])
    C1272705 (UMLS CUI [3,3])
    C0023467 (UMLS CUI [4,1])
    C0011906 (UMLS CUI [4,2])
    C1272705 (UMLS CUI [4,3])
    C0035647 (UMLS CUI [5,1])
    C0441833 (UMLS CUI [5,2])
    C1514983 (UMLS CUI [5,3])
    C1272705 (UMLS CUI [5,4])
    Cytotoxic agent
    Item
    5. the patient was treated before for a long time with cytotoxic drugs;
    boolean
    C0304497 (UMLS CUI [1])
    Therapeutic procedure Protocol Deviation | Therapeutic procedure Deviation Independent of Adverse effects | Therapeutic procedure Deviation Independent of Disease complication
    Item
    6. there were deviations in the treatment not covered by the protocol and/or not due to side effects of treatment and/or complications of the disease
    boolean
    C0087111 (UMLS CUI [1,1])
    C1705236 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C0205419 (UMLS CUI [2,2])
    C0332291 (UMLS CUI [2,3])
    C0879626 (UMLS CUI [2,4])
    C0087111 (UMLS CUI [3,1])
    C0205419 (UMLS CUI [3,2])
    C0332291 (UMLS CUI [3,3])
    C0544688 (UMLS CUI [3,4])
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