ID

30178

Beschrijving

Assessment and Determination of Chemotherapy Resistance in Newly-Diagnosed or First Relapse Leukemia Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00631059

Link

https://clinicaltrials.gov/show/NCT00631059

Trefwoorden

Versies (1)
  1. 17-05-18 17-05-18 -
Houder van rechten

See clinicaltrials.gov

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17 mei 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Leukemia NCT00631059

Engels

Eligibility Leukemia NCT00631059

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00631059
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed subjects
Beschrijving

Study Subject Newly Diagnosed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1518321
the subject is male or female, aged 18 years of age or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
the subject has a diagnosis of acute lymphocytic leukemia (all) or acute myelogenous leukemia (aml); the subject must have a pathology-confirmed diagnosis
Beschrijving

Acute lymphocytic leukemia | Leukemia, Myelocytic, Acute

Datatype

boolean

Alias
UMLS CUI [1]
C0023449
UMLS CUI [2]
C0023467
the subject must have a pathology-confirmed diagnosis
Beschrijving

Diagnosis Pathology Confirmed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0919386
UMLS CUI [1,3]
C0521093
acute lymphocytic leukemia (all) or acute myelogenous leukemia (aml) is defined as having >25% blasts in the bone marrow and/or peripheral blood
Beschrijving

Acute lymphocytic leukemia | Leukemia, Myelocytic, Acute | Blasts Bone marrow Percentage | Blast Cell Percentage Peripheral blood

Datatype

boolean

Alias
UMLS CUI [1]
C0023449
UMLS CUI [2]
C0023467
UMLS CUI [3,1]
C1982687
UMLS CUI [3,2]
C0439165
UMLS CUI [4,1]
C0368761
UMLS CUI [4,2]
C0439165
UMLS CUI [4,3]
C0229664
the subject has not received any chemotherapy or treatment for their acute leukemia prior to the initial study visit
Beschrijving

Absence Chemotherapy Acute leukemia | Absence Therapeutic procedure Acute leukemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0085669
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0085669
the subject is able and willing to provide written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
the subject is able to understand the study and cooperate with all study instructions
Beschrijving

Comprehension Study Protocol | Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
relapsed subjects
Beschrijving

Recurrent disease

Datatype

boolean

Alias
UMLS CUI [1]
C0277556
the subject is male or female, aged 18 years of age or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
the subject has a diagnosis of relapsed acute lymphocytic leukemia (all) or relapsed acute myelogenous leukemia (aml)
Beschrijving

ALL in relapse | AML in relapse

Datatype

boolean

Alias
UMLS CUI [1]
C2367454
UMLS CUI [2]
C2367456
the subject must have a pathology-confirmed diagnosis
Beschrijving

Diagnosis Pathology Confirmed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0919386
UMLS CUI [1,3]
C0521093
acute lymphocytic leukemia (all) or acute myelogenous leukemia (aml) is defined as having ≥ 25% blasts in the bone marrow and/or peripheral blood
Beschrijving

Acute lymphocytic leukemia | Leukemia, Myelocytic, Acute | Blasts Bone marrow Percentage | Blast Cell Percentage Peripheral blood

Datatype

boolean

Alias
UMLS CUI [1]
C0023449
UMLS CUI [2]
C0023467
UMLS CUI [3,1]
C1982687
UMLS CUI [3,2]
C0439165
UMLS CUI [4,1]
C0368761
UMLS CUI [4,2]
C0439165
UMLS CUI [4,3]
C0229664
the subject has received one or more of the pre-identified chemotherapeutic agents for treatment of their initial acute leukemia diagnosis
Beschrijving

Chemotherapeutic agent Quantity Acute leukemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0729502
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0085669
the subject has not received any systemic chemotherapy or treatment for their relapsed acute leukemia
Beschrijving

Absence Systemic Chemotherapy Acute leukemia in relapse | Absence Systemic therapy Acute leukemia in relapse

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1883256
UMLS CUI [1,3]
C2367453
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1515119
UMLS CUI [2,3]
C2367453
receipt of intrathecal chemotherapy will be permissible
Beschrijving

Intrathecal chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C1517560
the subject is able and willing to provide written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
the subject is able to understand the study and cooperate with all study instructions
Beschrijving

Comprehension Study Protocol | Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
the subject has an uncontrolled serious medical or psychiatric illness that, in the opinion of the investigator, would compromise the subject's safety or collection of data
Beschrijving

Disease Serious Uncontrolled | Serious mental illness Uncontrolled | At risk Patient safety | At risk Patient Data Collection

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C3841614
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C1444641
UMLS CUI [3,2]
C1113679
UMLS CUI [4,1]
C1444641
UMLS CUI [4,2]
C0030705
UMLS CUI [4,3]
C0010995
the subject received treatment with an investigational drug within two weeks of the initial or subsequent study visits
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
subjects under the age of 18
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
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Similar models

Eligibility Leukemia NCT00631059

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00631059
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Newly Diagnosed
Item
newly diagnosed subjects
boolean
C0681850 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
Age
Item
the subject is male or female, aged 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Acute lymphocytic leukemia | Leukemia, Myelocytic, Acute
Item
the subject has a diagnosis of acute lymphocytic leukemia (all) or acute myelogenous leukemia (aml); the subject must have a pathology-confirmed diagnosis
boolean
C0023449 (UMLS CUI [1])
C0023467 (UMLS CUI [2])
Diagnosis Pathology Confirmed
Item
the subject must have a pathology-confirmed diagnosis
boolean
C0011900 (UMLS CUI [1,1])
C0919386 (UMLS CUI [1,2])
C0521093 (UMLS CUI [1,3])
Acute lymphocytic leukemia | Leukemia, Myelocytic, Acute | Blasts Bone marrow Percentage | Blast Cell Percentage Peripheral blood
Item
acute lymphocytic leukemia (all) or acute myelogenous leukemia (aml) is defined as having >25% blasts in the bone marrow and/or peripheral blood
boolean
C0023449 (UMLS CUI [1])
C0023467 (UMLS CUI [2])
C1982687 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0368761 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
C0229664 (UMLS CUI [4,3])
Absence Chemotherapy Acute leukemia | Absence Therapeutic procedure Acute leukemia
Item
the subject has not received any chemotherapy or treatment for their acute leukemia prior to the initial study visit
boolean
C0332197 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0085669 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0085669 (UMLS CUI [2,3])
Informed Consent
Item
the subject is able and willing to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Comprehension Study Protocol | Protocol Compliance
Item
the subject is able to understand the study and cooperate with all study instructions
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Recurrent disease
Item
relapsed subjects
boolean
C0277556 (UMLS CUI [1])
Age
Item
the subject is male or female, aged 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
ALL in relapse | AML in relapse
Item
the subject has a diagnosis of relapsed acute lymphocytic leukemia (all) or relapsed acute myelogenous leukemia (aml)
boolean
C2367454 (UMLS CUI [1])
C2367456 (UMLS CUI [2])
Diagnosis Pathology Confirmed
Item
the subject must have a pathology-confirmed diagnosis
boolean
C0011900 (UMLS CUI [1,1])
C0919386 (UMLS CUI [1,2])
C0521093 (UMLS CUI [1,3])
Acute lymphocytic leukemia | Leukemia, Myelocytic, Acute | Blasts Bone marrow Percentage | Blast Cell Percentage Peripheral blood
Item
acute lymphocytic leukemia (all) or acute myelogenous leukemia (aml) is defined as having ≥ 25% blasts in the bone marrow and/or peripheral blood
boolean
C0023449 (UMLS CUI [1])
C0023467 (UMLS CUI [2])
C1982687 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0368761 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
C0229664 (UMLS CUI [4,3])
Chemotherapeutic agent Quantity Acute leukemia
Item
the subject has received one or more of the pre-identified chemotherapeutic agents for treatment of their initial acute leukemia diagnosis
boolean
C0729502 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0085669 (UMLS CUI [1,3])
Absence Systemic Chemotherapy Acute leukemia in relapse | Absence Systemic therapy Acute leukemia in relapse
Item
the subject has not received any systemic chemotherapy or treatment for their relapsed acute leukemia
boolean
C0332197 (UMLS CUI [1,1])
C1883256 (UMLS CUI [1,2])
C2367453 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C1515119 (UMLS CUI [2,2])
C2367453 (UMLS CUI [2,3])
Intrathecal chemotherapy
Item
receipt of intrathecal chemotherapy will be permissible
boolean
C1517560 (UMLS CUI [1])
Informed Consent
Item
the subject is able and willing to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Comprehension Study Protocol | Protocol Compliance
Item
the subject is able to understand the study and cooperate with all study instructions
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Disease Serious Uncontrolled | Serious mental illness Uncontrolled | At risk Patient safety | At risk Patient Data Collection
Item
the subject has an uncontrolled serious medical or psychiatric illness that, in the opinion of the investigator, would compromise the subject's safety or collection of data
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C3841614 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1444641 (UMLS CUI [3,1])
C1113679 (UMLS CUI [3,2])
C1444641 (UMLS CUI [4,1])
C0030705 (UMLS CUI [4,2])
C0010995 (UMLS CUI [4,3])
Investigational New Drugs
Item
the subject received treatment with an investigational drug within two weeks of the initial or subsequent study visits
boolean
C0013230 (UMLS CUI [1])
Age
Item
subjects under the age of 18
boolean
C0001779 (UMLS CUI [1])
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