ID

27753

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01953770

Nyckelord

Versioner (1)
  1. 2017-11-28 2017-11-28 -
Rättsinnehavare

See clinicaltrials.gov

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28 november 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Childhood Acute Lymphoblastic Leukemia NCT01953770

Engelsk

Eligibility Childhood Acute Lymphoblastic Leukemia NCT01953770

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age

Datatyp

boolean

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

Induction Therapy

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Informed Consent Parent | Informed Consent Guardian

Datatyp

boolean

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

Exclusion Criteria

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

Acute lymphocytic leukemia Second malignancy

Datatyp

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;
Beskrivning

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

Datatyp

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.);
Beskrivning

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

Datatyp

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);
Beskrivning

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

Datatyp

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;
Beskrivning

Cytotoxic agent

Datatyp

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
Beskrivning

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

Datatyp

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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Similar models

Eligibility Childhood Acute Lymphoblastic Leukemia NCT01953770

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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