ID

21439

Description

Acute Promyelocytic Leukemia 2006 (APL); ODM derived from: https://clinicaltrials.gov/show/NCT00378365

Link

https://clinicaltrials.gov/show/NCT00378365

Keywords

Versions (2)
  1. 4/21/17 4/21/17 -
  2. 4/21/17 4/21/17 -
Uploaded on

April 21, 2017

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License

Creative Commons BY 4.0
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Eligibility Leukemia, Promyelocytic, Acute NCT00378365

English

Eligibility Leukemia, Promyelocytic, Acute NCT00378365

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of apl based on morphological grounds, which will have to be confirmed by the presence of t(15;17) and/or pml-rara rearrangement with characterization of the bcr subtype (pml-rar characterization).
Description

Acute Promyelocytic Leukemia | t(15;17)(q22;q12) | t(15;17)(PML,RARA) | PML-RARa bcr1 fusion protein, human

Data type

boolean

Alias
UMLS CUI [1]
C0023487
UMLS CUI [2]
C1515724
UMLS CUI [3]
C1979990
UMLS CUI [4]
C3493223
untreated patients.
Description

Patients Untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
no contraindication to intensive chemotherapy (especially well documented cardiac contraindication to idarubicin).
Description

Chemotherapy intense Medical contraindication Absent | Idarubicin Medical contraindication cardiac Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C1301624
UMLS CUI [1,4]
C0332197
UMLS CUI [2,1]
C0020789
UMLS CUI [2,2]
C1301624
UMLS CUI [2,3]
C0018787
UMLS CUI [2,4]
C0332197
in female patients: absence of pregnancy and adequate contraceptive methods (due to teratogenetic effects of atra in early pregnancy).
Description

Gender Contraceptive methods | Pregnancy Absent | Tretinoin | Teratogenic effects Pregnancy Early

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0040845
UMLS CUI [4,1]
C0232910
UMLS CUI [4,2]
C0032961
UMLS CUI [4,3]
C1279919
absence of hypersensitivity to arsenic derivatives.
Description

Arsenic derivatives Hypersensitivity Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0003818
UMLS CUI [1,2]
C0243072
UMLS CUI [1,3]
C0020517
UMLS CUI [1,4]
C0332197
no qt interval prolongation or complete atria-ventricular block.
Description

Prolonged QT interval Absent | Complete atrioventricular block Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0151878
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0151517
UMLS CUI [2,2]
C0332197
written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients already treated.
Description

Patients Treated

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1522326
patients with contraindication to intensive chemotherapy, especially well documented cardiac contraindication to idarubicin.
Description

Medical contraindication Chemotherapy intense | Medical contraindication cardiac Idarubicin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0522510
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0018787
UMLS CUI [2,3]
C0020789
in female patients: pregnancy or absence of adequate contraceptive methods
Description

Pregnancy | Gender Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
qt interval prolongation or complete atria-ventricular block.
Description

Prolonged QT interval | Complete atrioventricular block

Data type

boolean

Alias
UMLS CUI [1]
C0151878
UMLS CUI [2]
C0151517
hypersensitivity to arsenic derivatives.
Description

Hypersensitivity Arsenic derivatives

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0003818
UMLS CUI [1,3]
C0243072
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Similar models

Eligibility Leukemia, Promyelocytic, Acute NCT00378365

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Acute Promyelocytic Leukemia | t(15;17)(q22;q12) | t(15;17)(PML,RARA) | PML-RARa bcr1 fusion protein, human
Item
diagnosis of apl based on morphological grounds, which will have to be confirmed by the presence of t(15;17) and/or pml-rara rearrangement with characterization of the bcr subtype (pml-rar characterization).
boolean
C0023487 (UMLS CUI [1])
C1515724 (UMLS CUI [2])
C1979990 (UMLS CUI [3])
C3493223 (UMLS CUI [4])
Patients Untreated
Item
untreated patients.
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Chemotherapy intense Medical contraindication Absent | Idarubicin Medical contraindication cardiac Absent
Item
no contraindication to intensive chemotherapy (especially well documented cardiac contraindication to idarubicin).
boolean
C0392920 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
C0020789 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
C0018787 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
Gender Contraceptive methods | Pregnancy Absent | Tretinoin | Teratogenic effects Pregnancy Early
Item
in female patients: absence of pregnancy and adequate contraceptive methods (due to teratogenetic effects of atra in early pregnancy).
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0040845 (UMLS CUI [3])
C0232910 (UMLS CUI [4,1])
C0032961 (UMLS CUI [4,2])
C1279919 (UMLS CUI [4,3])
Arsenic derivatives Hypersensitivity Absent
Item
absence of hypersensitivity to arsenic derivatives.
boolean
C0003818 (UMLS CUI [1,1])
C0243072 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Prolonged QT interval Absent | Complete atrioventricular block Absent
Item
no qt interval prolongation or complete atria-ventricular block.
boolean
C0151878 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0151517 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Informed Consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Patients Treated
Item
patients already treated.
boolean
C0030705 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
Medical contraindication Chemotherapy intense | Medical contraindication cardiac Idarubicin
Item
patients with contraindication to intensive chemotherapy, especially well documented cardiac contraindication to idarubicin.
boolean
C1301624 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0018787 (UMLS CUI [2,2])
C0020789 (UMLS CUI [2,3])
Pregnancy | Gender Contraceptive methods Absent
Item
in female patients: pregnancy or absence of adequate contraceptive methods
boolean
C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Prolonged QT interval | Complete atrioventricular block
Item
qt interval prolongation or complete atria-ventricular block.
boolean
C0151878 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
Hypersensitivity Arsenic derivatives
Item
hypersensitivity to arsenic derivatives.
boolean
C0020517 (UMLS CUI [1,1])
C0003818 (UMLS CUI [1,2])
C0243072 (UMLS CUI [1,3])
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