ID

14352

Beschrijving

New Retinoid Agent Combined With Arsenic Trioxide for Untreated Acute Promyelocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00670150

Link

https://clinicaltrials.gov/show/NCT00670150

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 NCT00670150

Eligibility Acute Promyelocytic Leukemia NCT00670150

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis patients must have a clinical diagnosis of acute promyelocytic leukemia (apl) morphology or fab m3 variant confirmed by rt-pcr assay for pml-rarα or chromosome analysis/fish showing t(15:17) translocation. a patient may be entered prior to confirmatory studies, but a patient who is subsequently found to be pml-rarα
Beschrijving

Acute Promyelocytic Leukemia

Datatype

boolean

Alias
UMLS CUI [1]
C0023487
prior treatment the patient must not have received any systemic definitive treatment for apl, including cytotoxic chemotherapy, retinoids or arsenic trioxide. prior therapy with corticosteroids, hydroxyurea or leukapheresis will not exclude the patient.
Beschrijving

Definitive Treatment

Datatype

boolean

Alias
UMLS CUI [1]
C2986592
Patients must be of age eighteen (18) or above.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Bilirubin equal or less than 1.5 times the upper limit of normal.
Beschrijving

Bilirubin

Datatype

boolean

Alias
UMLS CUI [1]
C0005437
Creatinine equal or less than 1.5 times the upper limit of normal
Beschrijving

Creatinine, Serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
Pregnancy / nursing status
Beschrijving

Pregnancy and Lactation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2986850
Patients entered into this study should be non-pregnant and non-nursing and should not plan on becoming pregnant while on treatment. treatment under this protocol would expose an unborn child to significant risks. treatment. women and men of reproductive potential should agree to use an effective means of birth control. there is an extremely high risk of fetal malformation if pregnancy occurs while on treatment in any amount with retinoid drugs even for short periods.
Beschrijving

Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
non-apl, aml patients should be excluded from the study.
Beschrijving

Acute Myelocytic Leukemia

Datatype

boolean

Alias
UMLS CUI [1]
C0023467
Other serious illnesses which would limit survival to 1 year.
Beschrijving

Life expectancy shortened

Datatype

boolean

Alias
UMLS CUI [1]
C1504437
psychiatric conditions which would prevent compliance with treatment or informed consent.
Beschrijving

Mental disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
uncontrolled or severe cardiovascular disease. this would include history of a recent acute myocardial infarction, uncontrolled congestive heart failure, or active angina.
Beschrijving

Cardiovascular Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
aids or hiv positive patients, although hiv test is not required for accrual.
Beschrijving

HIV

Datatype

boolean

Alias
UMLS CUI [1]
C0019682

Similar models

Eligibility Acute Promyelocytic Leukemia NCT00670150

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Acute Promyelocytic Leukemia
Item
diagnosis patients must have a clinical diagnosis of acute promyelocytic leukemia (apl) morphology or fab m3 variant confirmed by rt-pcr assay for pml-rarα or chromosome analysis/fish showing t(15:17) translocation. a patient may be entered prior to confirmatory studies, but a patient who is subsequently found to be pml-rarα
boolean
C0023487 (UMLS CUI [1])
Definitive Treatment
Item
prior treatment the patient must not have received any systemic definitive treatment for apl, including cytotoxic chemotherapy, retinoids or arsenic trioxide. prior therapy with corticosteroids, hydroxyurea or leukapheresis will not exclude the patient.
boolean
C2986592 (UMLS CUI [1])
Age
Item
Patients must be of age eighteen (18) or above.
boolean
C0001779 (UMLS CUI [1])
Bilirubin
Item
Bilirubin equal or less than 1.5 times the upper limit of normal.
boolean
C0005437 (UMLS CUI [1])
Creatinine, Serum
Item
Creatinine equal or less than 1.5 times the upper limit of normal
boolean
C0201976 (UMLS CUI [1])
Pregnancy and Lactation Status
Item
Pregnancy / nursing status
boolean
C2986850 (UMLS CUI [1])
Contraceptive methods
Item
Patients entered into this study should be non-pregnant and non-nursing and should not plan on becoming pregnant while on treatment. treatment under this protocol would expose an unborn child to significant risks. treatment. women and men of reproductive potential should agree to use an effective means of birth control. there is an extremely high risk of fetal malformation if pregnancy occurs while on treatment in any amount with retinoid drugs even for short periods.
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Acute Myelocytic Leukemia
Item
non-apl, aml patients should be excluded from the study.
boolean
C0023467 (UMLS CUI [1])
Life expectancy shortened
Item
Other serious illnesses which would limit survival to 1 year.
boolean
C1504437 (UMLS CUI [1])
Mental disorders
Item
psychiatric conditions which would prevent compliance with treatment or informed consent.
boolean
C0004936 (UMLS CUI [1])
Cardiovascular Diseases
Item
uncontrolled or severe cardiovascular disease. this would include history of a recent acute myocardial infarction, uncontrolled congestive heart failure, or active angina.
boolean
C0007222 (UMLS CUI [1])
HIV
Item
aids or hiv positive patients, although hiv test is not required for accrual.
boolean
C0019682 (UMLS CUI [1])

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