ID

14354

Beschrijving

Treatment Study for Children and Adolescents With Acute Promyelocitic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01226303

Link

https://clinicaltrials.gov/show/NCT01226303

Trefwoorden

  1. 12-04-16 12-04-16 -
Geüploaded op

12 april 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Acute Promyelocytic Leukemia NCT01226303

Eligibility Acute Promyelocytic Leukemia NCT01226303

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with a clinical diagnosis of initial apl and subsequently confirmed to have pml-rarα, npm1-rarα or numa-rarα fusion. whilst this study is only for atra-sensitive apl, apl is a hematological emergency and atra should be commenced as soon as the diagnosis is suspected. study entry should not wait until the diagnosis of apl has been confirmed molecularly or cytogenetically
Beschrijving

Acute Promyelocytic Leukemia

Datatype

boolean

Alias
UMLS CUI [1]
C0023487
less than 21 years of age at initial diagnosis (for aieop, see appendix a)
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
considered suitable for anthracycline-based chemotherapy
Beschrijving

Anthracyclines

Datatype

boolean

Alias
UMLS CUI [1]
C0282564
Informed Consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Negative serum test to rule out pregnancy within 2 weeks prior to registration in females of childbearing potential (non childbearing potential defined as premenarchal, greater than one year post-menopausal, or surgically sterilized)
Beschrijving

Patient not pregnant

Datatype

boolean

Alias
UMLS CUI [1]
C0232973
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a clinical diagnosis of apl but subsequently found to have plzf-rarα
Beschrijving

RARA/ZBTB16 Fusion Protein

Datatype

boolean

Alias
UMLS CUI [1]
C3537406
fusion or lacking pml-rarα, npm-rarα or numa-rarα rearrangement should be withdrawn from the study and treated on an alternative protocol.
Beschrijving

Retinoic Acid Receptor

Datatype

boolean

Alias
UMLS CUI [1]
C0140278
refractory/relapsed apl (the guidelines in this protocol for that subgroup are intended for patients treated from initial diagnosis according to this protocol)
Beschrijving

Relapse

Datatype

boolean

Alias
UMLS CUI [1]
C0035020
concurrent active malignancy
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
Pregnant or lactating
Beschrijving

Pregnant or lactating

Datatype

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C2828358
physician and patient/guardian think that intensive chemotherapy is not an appropriate treatment option
Beschrijving

Chemotherapy Regimen

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
patients who have received alternative chemotherapy for 7 days or longer without atra for any reason (either apl not initially suspected or atra not available).
Beschrijving

Tretinoin

Datatype

boolean

Alias
UMLS CUI [1]
C0040845

Similar models

Eligibility Acute Promyelocytic Leukemia NCT01226303

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Acute Promyelocytic Leukemia
Item
patients with a clinical diagnosis of initial apl and subsequently confirmed to have pml-rarα, npm1-rarα or numa-rarα fusion. whilst this study is only for atra-sensitive apl, apl is a hematological emergency and atra should be commenced as soon as the diagnosis is suspected. study entry should not wait until the diagnosis of apl has been confirmed molecularly or cytogenetically
boolean
C0023487 (UMLS CUI [1])
Age
Item
less than 21 years of age at initial diagnosis (for aieop, see appendix a)
boolean
C0001779 (UMLS CUI [1])
Anthracyclines
Item
considered suitable for anthracycline-based chemotherapy
boolean
C0282564 (UMLS CUI [1])
Informed Consent
Item
Informed Consent
boolean
C0021430 (UMLS CUI [1])
Patient not pregnant
Item
Negative serum test to rule out pregnancy within 2 weeks prior to registration in females of childbearing potential (non childbearing potential defined as premenarchal, greater than one year post-menopausal, or surgically sterilized)
boolean
C0232973 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
RARA/ZBTB16 Fusion Protein
Item
patients with a clinical diagnosis of apl but subsequently found to have plzf-rarα
boolean
C3537406 (UMLS CUI [1])
Retinoic Acid Receptor
Item
fusion or lacking pml-rarα, npm-rarα or numa-rarα rearrangement should be withdrawn from the study and treated on an alternative protocol.
boolean
C0140278 (UMLS CUI [1])
Relapse
Item
refractory/relapsed apl (the guidelines in this protocol for that subgroup are intended for patients treated from initial diagnosis according to this protocol)
boolean
C0035020 (UMLS CUI [1])
Malignant Neoplasms
Item
concurrent active malignancy
boolean
C0006826 (UMLS CUI [1])
Pregnant or lactating
Item
Pregnant or lactating
boolean
C0549206 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
Chemotherapy Regimen
Item
physician and patient/guardian think that intensive chemotherapy is not an appropriate treatment option
boolean
C0392920 (UMLS CUI [1])
Tretinoin
Item
patients who have received alternative chemotherapy for 7 days or longer without atra for any reason (either apl not initially suspected or atra not available).
boolean
C0040845 (UMLS CUI [1])

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