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ID

41112

Description

Pre and Post Treatment Metabolomic Analysis of Leukemia: A Translational Clinical Trial of the Brown Cancer Center; ODM derived from: https://clinicaltrials.gov/show/NCT02193100

Link

https://clinicaltrials.gov/show/NCT02193100

Keywords

Versions (1)
  1. 6/25/20 6/25/20 -
Copyright Holder

See clinicaltrials.gov

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June 25, 2020

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Creative Commons BY 4.0
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    Eligibility Leukemia NCT02193100

    English

    Eligibility Leukemia NCT02193100

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT02193100
    Criteria
    Description

    Criteria

    each of the criteria in the following section must be met in order for a patient to be eligible for enrollment.
    Description

    Criteria All Fulfill

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0243161
    UMLS CUI [1,2]
    C0444868
    UMLS CUI [1,3]
    C1550543
    only patients with clinically diagnosed or histologically diagnosed leukemia will be eligible to participate in this non-therapeutic study.
    Description

    Leukemia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023418
    all patients must have measurable quantities of leukemic blasts on peripheral blood detected with a cbc.
    Description

    Leukemic Blast Count Peripheral blood | Complete Blood Count

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2697913
    UMLS CUI [1,2]
    C0229664
    UMLS CUI [2]
    C0009555
    no history of diabetes for the experimental group or the control group.
    Description

    History of diabetes mellitus Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0455488
    UMLS CUI [1,2]
    C0332197
    patients with known hepatitis c or hiv (aids) are excluded.
    Description

    Hepatitis C Excluded | HIV Infection Excluded | AIDS Excluded

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019196
    UMLS CUI [1,2]
    C0332196
    UMLS CUI [2,1]
    C0019693
    UMLS CUI [2,2]
    C0332196
    UMLS CUI [3,1]
    C0001175
    UMLS CUI [3,2]
    C0332196
    patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    inclusion criteria forhealthy subjects:
    Description

    Inclusion criteria Healthy Volunteers

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C1708335
    subjects must have no known prior history of cancer or malignant blood disorders.-where possible, follow up will be carried out to verify that no cancer has developed since the blood collection. this will be done by a phone call performed one month from sample to ask if new medical conditions have arisen.
    Description

    History of malignant neoplasm Absent | Hematologic Neoplasms Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0455471
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [2,1]
    C0376545
    UMLS CUI [2,2]
    C0332197
    subjects must have wbc, rbc, and platelet counts within normal range on cbc.
    Description

    White Blood Cell Count procedure Normal | RBC count normal | Platelet count normal | Complete Blood Count

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0023508
    UMLS CUI [1,2]
    C0205307
    UMLS CUI [2]
    C0427455
    UMLS CUI [3]
    C0427564
    UMLS CUI [4]
    C0009555
    subjects with known hepatitis c or hiv (aids) are excluded.
    Description

    Hepatitis C Excluded | HIV Infection Excluded | AIDS Excluded

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019196
    UMLS CUI [1,2]
    C0332196
    UMLS CUI [2,1]
    C0019693
    UMLS CUI [2,2]
    C0332196
    UMLS CUI [3,1]
    C0001175
    UMLS CUI [3,2]
    C0332196
    no history of diabetes
    Description

    History of diabetes mellitus Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0455488
    UMLS CUI [1,2]
    C0332197
    at least 30 years of age
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    preferably be fasting for 12 hours (minimum 8 hours) prior to enrollment
    Description

    Preference Fasting Duration

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0558295
    UMLS CUI [1,2]
    C0015663
    UMLS CUI [1,3]
    C0449238
    patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    none listed in protocol
    Description

    Unspecified

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0205370
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    Similar models

    Eligibility Leukemia NCT02193100

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT02193100
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Criteria All Fulfill
    Item
    each of the criteria in the following section must be met in order for a patient to be eligible for enrollment.
    boolean
    C0243161 (UMLS CUI [1,1])
    C0444868 (UMLS CUI [1,2])
    C1550543 (UMLS CUI [1,3])
    Leukemia
    Item
    only patients with clinically diagnosed or histologically diagnosed leukemia will be eligible to participate in this non-therapeutic study.
    boolean
    C0023418 (UMLS CUI [1])
    Leukemic Blast Count Peripheral blood | Complete Blood Count
    Item
    all patients must have measurable quantities of leukemic blasts on peripheral blood detected with a cbc.
    boolean
    C2697913 (UMLS CUI [1,1])
    C0229664 (UMLS CUI [1,2])
    C0009555 (UMLS CUI [2])
    History of diabetes mellitus Absent
    Item
    no history of diabetes for the experimental group or the control group.
    boolean
    C0455488 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    Hepatitis C Excluded | HIV Infection Excluded | AIDS Excluded
    Item
    patients with known hepatitis c or hiv (aids) are excluded.
    boolean
    C0019196 (UMLS CUI [1,1])
    C0332196 (UMLS CUI [1,2])
    C0019693 (UMLS CUI [2,1])
    C0332196 (UMLS CUI [2,2])
    C0001175 (UMLS CUI [3,1])
    C0332196 (UMLS CUI [3,2])
    Informed Consent
    Item
    patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
    boolean
    C0021430 (UMLS CUI [1])
    Inclusion criteria Healthy Volunteers
    Item
    inclusion criteria forhealthy subjects:
    boolean
    C1512693 (UMLS CUI [1,1])
    C1708335 (UMLS CUI [1,2])
    History of malignant neoplasm Absent | Hematologic Neoplasms Absent
    Item
    subjects must have no known prior history of cancer or malignant blood disorders.-where possible, follow up will be carried out to verify that no cancer has developed since the blood collection. this will be done by a phone call performed one month from sample to ask if new medical conditions have arisen.
    boolean
    C0455471 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C0376545 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    White Blood Cell Count procedure Normal | RBC count normal | Platelet count normal | Complete Blood Count
    Item
    subjects must have wbc, rbc, and platelet counts within normal range on cbc.
    boolean
    C0023508 (UMLS CUI [1,1])
    C0205307 (UMLS CUI [1,2])
    C0427455 (UMLS CUI [2])
    C0427564 (UMLS CUI [3])
    C0009555 (UMLS CUI [4])
    Hepatitis C Excluded | HIV Infection Excluded | AIDS Excluded
    Item
    subjects with known hepatitis c or hiv (aids) are excluded.
    boolean
    C0019196 (UMLS CUI [1,1])
    C0332196 (UMLS CUI [1,2])
    C0019693 (UMLS CUI [2,1])
    C0332196 (UMLS CUI [2,2])
    C0001175 (UMLS CUI [3,1])
    C0332196 (UMLS CUI [3,2])
    History of diabetes mellitus Absent
    Item
    no history of diabetes
    boolean
    C0455488 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    Age
    Item
    at least 30 years of age
    boolean
    C0001779 (UMLS CUI [1])
    Preference Fasting Duration
    Item
    preferably be fasting for 12 hours (minimum 8 hours) prior to enrollment
    boolean
    C0558295 (UMLS CUI [1,1])
    C0015663 (UMLS CUI [1,2])
    C0449238 (UMLS CUI [1,3])
    Informed Consent
    Item
    patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Unspecified
    Item
    none listed in protocol
    boolean
    C0205370 (UMLS CUI [1])
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