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

Uploaded on

June 25, 2020

DOI

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License

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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