ID

17854

Beschrijving

Gene Expression During Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Choline Magnesium Trisalicylate; ODM derived from: https://clinicaltrials.gov/show/NCT00156299

Link

https://clinicaltrials.gov/show/NCT00156299

Trefwoorden

Versies (2)
  1. 05-10-16 05-10-16 -
  2. 05-10-16 05-10-16 -
Geüploaded op

5 oktober 2016

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility Leukemia NCT00156299

Engels

Eligibility Leukemia NCT00156299

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00156299
Criteria
Beschrijving

Criteria

histologically confirmed acute myeloid leukemia
Beschrijving

Leukemia, Myelocytic, Acute

Datatype

boolean

Alias
UMLS CUI [1]
C0023467
newly diagnosed disease
Beschrijving

Newly Diagnosed Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1334965
presence of cytogenetic abnormalities must be determined by standard cytogenetics with or without fish studies
Beschrijving

Chromosome Aberrations | Cytogenetic Analysis | Fluorescent in Situ Hybridization

Datatype

boolean

Alias
UMLS CUI [1]
C0008625
UMLS CUI [2]
C0752095
UMLS CUI [3]
C0162789
leukemic blast count > 5,000/mm³ of peripheral blood
Beschrijving

Leukemic Blast Count peripheral blood

Datatype

boolean

Alias
UMLS CUI [1,1]
C2697913
UMLS CUI [1,2]
C0229664
no acute promyelocytic leukemia (m3)
Beschrijving

Acute Promyelocytic Leukemia

Datatype

boolean

Alias
UMLS CUI [1]
C0023487
patient characteristics:
Beschrijving

Client Characteristics

Datatype

boolean

Alias
UMLS CUI [1]
C0815172
ecog performance status 0-3
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
bilirubin < 2.0 times upper limit of normal (uln)
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
ast < 3.0 times uln
Beschrijving

Aspartate aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
creatinine < 1.5 times uln
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
not pregnant or nursing
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
negative pregnancy test
Beschrijving

Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective contraception
Beschrijving

Fertility Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no uncontrolled psychiatric illness that, in the opinion of the principal investigator, would preclude study compliance
Beschrijving

Mental disorder Uncontrolled Excludes Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C0525058
no other concurrent medical condition that would preclude study compliance
Beschrijving

Comorbidity Excludes Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
no allergies to any investigational drugs and/or chemotherapeutic agents
Beschrijving

Hypersensitivity Investigational New Drugs | Hypersensitivity Antineoplastic Agents

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0003392
no upper or lower gastrointestinal (gi) related hemorrhage within the past 6 months as determined by endoscopy
Beschrijving

Upper gastrointestinal hemorrhage | Lower gastrointestinal hemorrhage

Datatype

boolean

Alias
UMLS CUI [1]
C0041909
UMLS CUI [2]
C0024050
no clinical diagnosis of gi bleeding requiring blood transfusions
Beschrijving

Gastrointestinal Hemorrhage Requirement Blood Transfusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0017181
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0005841
prior concurrent therapy:
Beschrijving

Comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
no prior induction therapy
Beschrijving

Neoadjuvant Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0600558
no prior chemotherapy for acute leukemia
Beschrijving

Prior Chemotherapy Acute leukemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0085669
no concurrent medications that would preclude study compliance
Beschrijving

Pharmaceutical Preparations Exclude Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
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Similar models

Eligibility Leukemia NCT00156299

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00156299
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Leukemia, Myelocytic, Acute
Item
histologically confirmed acute myeloid leukemia
boolean
C0023467 (UMLS CUI [1])
Newly Diagnosed Disease
Item
newly diagnosed disease
boolean
C1334965 (UMLS CUI [1])
Chromosome Aberrations | Cytogenetic Analysis | Fluorescent in Situ Hybridization
Item
presence of cytogenetic abnormalities must be determined by standard cytogenetics with or without fish studies
boolean
C0008625 (UMLS CUI [1])
C0752095 (UMLS CUI [2])
C0162789 (UMLS CUI [3])
Leukemic Blast Count peripheral blood
Item
leukemic blast count > 5,000/mm³ of peripheral blood
boolean
C2697913 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
Acute Promyelocytic Leukemia
Item
no acute promyelocytic leukemia (m3)
boolean
C0023487 (UMLS CUI [1])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-3
boolean
C1520224 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin < 2.0 times upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
ast < 3.0 times uln
boolean
C0201899 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine < 1.5 times uln
boolean
C0201976 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Mental disorder Uncontrolled Excludes Protocol Compliance
Item
no uncontrolled psychiatric illness that, in the opinion of the principal investigator, would preclude study compliance
boolean
C0004936 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
Comorbidity Excludes Protocol Compliance
Item
no other concurrent medical condition that would preclude study compliance
boolean
C0009488 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Antineoplastic Agents
Item
no allergies to any investigational drugs and/or chemotherapeutic agents
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0003392 (UMLS CUI [2,2])
Upper gastrointestinal hemorrhage | Lower gastrointestinal hemorrhage
Item
no upper or lower gastrointestinal (gi) related hemorrhage within the past 6 months as determined by endoscopy
boolean
C0041909 (UMLS CUI [1])
C0024050 (UMLS CUI [2])
Gastrointestinal Hemorrhage Requirement Blood Transfusion
Item
no clinical diagnosis of gi bleeding requiring blood transfusions
boolean
C0017181 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0005841 (UMLS CUI [1,3])
Comorbidity
Item
prior concurrent therapy:
boolean
C0009488 (UMLS CUI [1])
Neoadjuvant Therapy
Item
no prior induction therapy
boolean
C0600558 (UMLS CUI [1])
Prior Chemotherapy Acute leukemia
Item
no prior chemotherapy for acute leukemia
boolean
C1514457 (UMLS CUI [1,1])
C0085669 (UMLS CUI [1,2])
Pharmaceutical Preparations Exclude Protocol Compliance
Item
no concurrent medications that would preclude study compliance
boolean
C0013227 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
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