ID

14386

Descrição

Biomarkers to Classify Young Patients With Acute Lymphoblastic Leukemia (ALL) and Remission Induction Therapy in Young Patients With B-Precursor ALL; ODM derived from: https://clinicaltrials.gov/show/NCT01225874

Link

https://clinicaltrials.gov/show/NCT01225874

Palavras-chave

Versões (1)
  1. 12/04/2016 12/04/2016 -
Transferido a

12 de abril de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Leukemia NCT01225874

Inglês

Eligibility Leukemia NCT01225874

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01225874
Criteria
Descrição

Criteria

meets one of the following sets of criteria:
Descrição

Inclusion criteria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1512693
classification study:
Descrição

Participation status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
newly diagnosed all*
Descrição

ALL: date of diagnosis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023449
UMLS CUI [1,2]
C2316983
must have one of the following:
Descrição

Criteria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0242801
≥ 25% blasts in bone marrow
Descrição

Blasts in bone marrow

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1982687
≥ 100,000/μl peripheral blood wbc with ≥ 75% blasts, if bone marrow aspiration is omitted for any reason other than medical contraindication
Descrição

White blood count and blasts

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0523113
UMLS CUI [3,1]
C0398523
UMLS CUI [3,2]
C0445106
≥ 30,000/μl wbc with ≥ 75% blasts, if bone marrow aspiration is omitted because of medical contraindication
Descrição

White blood count and blasts

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0523113
UMLS CUI [3,1]
C0398523
UMLS CUI [3,2]
C1301624
immunophenotype and wright's stain morphology of blast cells consistent with acute lymphocytic leukemia
Descrição

Immunophenotyping and wrights stain morphology

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079611
UMLS CUI [2]
C0770761
≤ 21 years of age at the time of diagnosis
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
no previous registration on 9900
Descrição

Participation status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
samples must be sent for local institution and cog reference laboratory studies note: *it is urged that a bone marrow aspiration be performed for every patient with suspected all. however, a marrow is not required for patients with ≥ 100,000/μl peripheral blood wbc and ≥ 75% blasts or for those patients whose clinical condition precludes performing the procedure safely. patients with a medical contraindication to the procedure must be discussed with one of the study coordinators and must have a peripheral blood wbc of ≥ 30,000/μl with ≥ 75% blasts.
Descrição

Bone marrow aspiration and peripheral blood specimen

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0398523
UMLS CUI [2]
C1292451
induction therapy study:
Descrição

Induction therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3179010
patients must have a confirmed diagnosis of b-precursor acute lymphoblastic leukemia
Descrição

B-precursor acute lymphoblastic leukemia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1737235
patients must be 1.001 to 21.999 years at diagnosis note: patients meeting all of the above eligibility criteria are eligible for registration on 9900 whether or not they are to be entered on a cog frontline protocol for treatment of newly diagnosed all. registration on 9900 is required for all legacy pog institution patients in order to be eligible for entry on the following cog all studies, which are either currently open or only temporarily closed: p9407, 9904, 9905, 9907, aall0031 and aall00p2.
Descrição

Age and participation status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C2348568
patient characteristics:
Descrição

Patient characteristics

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0815172
see disease characteristics
Descrição

Disease characteristics

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1705348
prior concurrent therapy:
Descrição

Concurrent therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009429
previously untreated, with the following exception:
Descrição

Untreated

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0332155
steroid treatment* in the 48-hour period just prior to study entry will be allowed provided that a physical examination and cbc with differential were performed immediately prior to beginning steroids and results of both are known note: *patients on chronic steroid treatment for another disease are not eligible for a cog new all protocol.
Descrição

Steroid treatment, physical examination and CBC

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C2584899
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0009555
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Similar models

Eligibility Leukemia NCT01225874

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01225874
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion criteria
Item
meets one of the following sets of criteria:
boolean
C1512693 (UMLS CUI [1])
Participation status
Item
classification study:
boolean
C2348568 (UMLS CUI [1])
ALL: date of diagnosis
Item
newly diagnosed all*
boolean
C0023449 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Criteria
Item
must have one of the following:
boolean
C0242801 (UMLS CUI [1])
Blasts in bone marrow
Item
≥ 25% blasts in bone marrow
boolean
C1982687 (UMLS CUI [1])
White blood count and blasts
Item
≥ 100,000/μl peripheral blood wbc with ≥ 75% blasts, if bone marrow aspiration is omitted for any reason other than medical contraindication
boolean
C0023508 (UMLS CUI [1])
C0523113 (UMLS CUI [2])
C0398523 (UMLS CUI [3,1])
C0445106 (UMLS CUI [3,2])
White blood count and blasts
Item
≥ 30,000/μl wbc with ≥ 75% blasts, if bone marrow aspiration is omitted because of medical contraindication
boolean
C0023508 (UMLS CUI [1])
C0523113 (UMLS CUI [2])
C0398523 (UMLS CUI [3,1])
C1301624 (UMLS CUI [3,2])
Immunophenotyping and wrights stain morphology
Item
immunophenotype and wright's stain morphology of blast cells consistent with acute lymphocytic leukemia
boolean
C0079611 (UMLS CUI [1])
C0770761 (UMLS CUI [2])
Age
Item
≤ 21 years of age at the time of diagnosis
boolean
C0001779 (UMLS CUI [1])
Participation status
Item
no previous registration on 9900
boolean
C2348568 (UMLS CUI [1])
Bone marrow aspiration and peripheral blood specimen
Item
samples must be sent for local institution and cog reference laboratory studies note: *it is urged that a bone marrow aspiration be performed for every patient with suspected all. however, a marrow is not required for patients with ≥ 100,000/μl peripheral blood wbc and ≥ 75% blasts or for those patients whose clinical condition precludes performing the procedure safely. patients with a medical contraindication to the procedure must be discussed with one of the study coordinators and must have a peripheral blood wbc of ≥ 30,000/μl with ≥ 75% blasts.
boolean
C0398523 (UMLS CUI [1])
C1292451 (UMLS CUI [2])
Induction therapy
Item
induction therapy study:
boolean
C3179010 (UMLS CUI [1])
B-precursor acute lymphoblastic leukemia
Item
patients must have a confirmed diagnosis of b-precursor acute lymphoblastic leukemia
boolean
C1737235 (UMLS CUI [1])
Age and participation status
Item
patients must be 1.001 to 21.999 years at diagnosis note: patients meeting all of the above eligibility criteria are eligible for registration on 9900 whether or not they are to be entered on a cog frontline protocol for treatment of newly diagnosed all. registration on 9900 is required for all legacy pog institution patients in order to be eligible for entry on the following cog all studies, which are either currently open or only temporarily closed: p9407, 9904, 9905, 9907, aall0031 and aall00p2.
boolean
C0001779 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Patient characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Disease characteristics
Item
see disease characteristics
boolean
C1705348 (UMLS CUI [1])
Concurrent therapy
Item
prior concurrent therapy:
boolean
C0009429 (UMLS CUI [1])
Untreated
Item
previously untreated, with the following exception:
boolean
C0332155 (UMLS CUI [1])
Steroid treatment, physical examination and CBC
Item
steroid treatment* in the 48-hour period just prior to study entry will be allowed provided that a physical examination and cbc with differential were performed immediately prior to beginning steroids and results of both are known note: *patients on chronic steroid treatment for another disease are not eligible for a cog new all protocol.
boolean
C0149783 (UMLS CUI [1,1])
C2584899 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2])
C0009555 (UMLS CUI [3])
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