Eligibility Acute Promyelocytic Leukemia NCT00465933

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age <= 75 years
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog = 3.
Beschreibung

ecog

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
morphological diagnosis of m3 or m3v. those cases without typical morphology but with pml-rara rearrangement may also be included.
Beschreibung

FAB-classification

Datentyp

boolean

Alias
UMLS CUI [1]
C2984084
genetic diagnosis: t(15;17), pml-rara rearrangement, monoclonal anti-pml positive. obviously, the result of these tests may become available after having initiated the treatment based on a tentative morphological diagnosis. the presence of secondary cytogenetic changes associated with t(15;17) is not a reason for exclusion nor do they require a different therapeutic approach.
Beschreibung

genetic testing

Datentyp

boolean

Alias
UMLS CUI [1]
C0679560
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
age > 75 years (the treatment with this protocol can be considered on an individual basis but these patients will be analysed separately)
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
absence of pml-rara rearrangement.
Beschreibung

pml-rara rearrangement

Datentyp

boolean

Alias
UMLS CUI [1]
C1979990
prior antileukemic chemotherapy.
Beschreibung

antileukemic chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0023418
presence of an associated neoplasm.
Beschreibung

associated neoplasm

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
presence of a severe psychiatric disease.
Beschreibung

mental status

Datentyp

boolean

Alias
UMLS CUI [1]
C0004936
hiv seropositivity.
Beschreibung

HIV

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
contraindication for intensive chemotherapy, especially to anthracyclines.
Beschreibung

Contraindication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0392920
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0282564
serum creatinine = 2.5 mg/dl.
Beschreibung

renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
bilirubin, alkaline phosphatase, or sgot > 3 times the upper normal limit
Beschreibung

liver function

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201850
UMLS CUI [3]
C0201899
positive pregnancy test.
Beschreibung

gynaecological status

Datentyp

boolean

Alias
UMLS CUI [1]
C0032976

Ähnliche Modelle

Eligibility Acute Promyelocytic Leukemia NCT00465933

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age <= 75 years
boolean
C0001779 (UMLS CUI [1])
ecog
Item
ecog = 3.
boolean
C1520224 (UMLS CUI [1])
FAB-classification
Item
morphological diagnosis of m3 or m3v. those cases without typical morphology but with pml-rara rearrangement may also be included.
boolean
C2984084 (UMLS CUI [1])
genetic testing
Item
genetic diagnosis: t(15;17), pml-rara rearrangement, monoclonal anti-pml positive. obviously, the result of these tests may become available after having initiated the treatment based on a tentative morphological diagnosis. the presence of secondary cytogenetic changes associated with t(15;17) is not a reason for exclusion nor do they require a different therapeutic approach.
boolean
C0679560 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
age
Item
age > 75 years (the treatment with this protocol can be considered on an individual basis but these patients will be analysed separately)
boolean
C0001779 (UMLS CUI [1])
pml-rara rearrangement
Item
absence of pml-rara rearrangement.
boolean
C1979990 (UMLS CUI [1])
antileukemic chemotherapy
Item
prior antileukemic chemotherapy.
boolean
C0392920 (UMLS CUI [1,1])
C0023418 (UMLS CUI [1,2])
associated neoplasm
Item
presence of an associated neoplasm.
boolean
C0006826 (UMLS CUI [1])
mental status
Item
presence of a severe psychiatric disease.
boolean
C0004936 (UMLS CUI [1])
HIV
Item
hiv seropositivity.
boolean
C0019699 (UMLS CUI [1])
Contraindication
Item
contraindication for intensive chemotherapy, especially to anthracyclines.
boolean
C1301624 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0282564 (UMLS CUI [2,2])
renal function
Item
serum creatinine = 2.5 mg/dl.
boolean
C0201976 (UMLS CUI [1])
liver function
Item
bilirubin, alkaline phosphatase, or sgot > 3 times the upper normal limit
boolean
C1278039 (UMLS CUI [1])
C0201850 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
gynaecological status
Item
positive pregnancy test.
boolean
C0032976 (UMLS CUI [1])