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Study of the Intermediate Metabolism in Children With Acute Lymphoblastic Leukemia (ALL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03035344
Recruitment Status : Unknown
Verified January 2017 by Maria T. Papadopoulou, Aristotle University Of Thessaloniki.
Recruitment status was:  Recruiting
First Posted : January 30, 2017
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
Maria T. Papadopoulou, Aristotle University Of Thessaloniki

Tracking Information
First Submitted Date January 26, 2017
First Posted Date January 30, 2017
Last Update Posted Date January 30, 2017
Study Start Date May 2015
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 26, 2017)
Difference in measurement of aminoacids and organic acids between ALL patients and healthy matched controls. [ Time Frame: Up to six months ]
The title of aminoacids in blood and urine and of organic acids in urine will be measured through Tandem Mass Spectrometry
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of the Intermediate Metabolism in Children With Acute Lymphoblastic Leukemia (ALL)
Official Title Study of the Intermediate Metabolism in Children With Acute Lymphoblastic Leukemia
Brief Summary Study of the intermediate metabolism in children diagnosed with ALL compared to healthy matched controls.
Detailed Description The primary cause of this study is to investigate the changes that ALL may cause to the metabolome of pediatric patients, in order to better understand its mechanism of action and target metabolic pathways for potential therapies.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood, urine, bone marrow
Sampling Method Non-Probability Sample
Study Population Children diagnosed with acute lymphoblastic leukemia
Condition
  • Acute Lymphoblastic Leukemia, Pediatric
  • Metabolism Disorder
Intervention Other: Metabolome study
Metabolome study in ALL patients compared to healthy controls
Study Groups/Cohorts
  • ALL paediatric patients
    Metabolome study in children diagnosed with ALL after bone marrow biopsy
    Intervention: Other: Metabolome study
  • Healthy matched controls
    Metabolome study in healthy children matched for gender and age with the patients group
    Intervention: Other: Metabolome study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 26, 2017)
25
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2018
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • Sex: all
  • Minimum age: 1 year
  • Maximum age: 16 years
  • The study accepts healthy volunteers as matched controls for the patinets.
  • Inclusion criteria: 1)Children diagnosed with ALL 2) Diagnosis confirmed with bone marrow biopsy 3) Sampling before the initiation of therapy 4) Informed consent signed
  • Exclusion Criteria: 1) Children with a known chronic illness before ALL diagnosis 2) ALL remission 3) Not signed informed consent
  • Population description: Patients are recruited from the Pediatric Hematology/Oncology Department of Aristotle University of Thessaloniki (AHEPA hospital) and from the Pediatric Hematology/ Oncology Department of Ippokration Hospital, that host all children diagnosed with ALL in nothern Greece. Matched controls are recruited from outpatient clinic of the 2nd and 4th Pediatric Department of Aristotle University of Thessaloniki.
  • Sampling method: Non-probability sample
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Month to 16 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT03035344
Other Study ID Numbers CHILDHOOD ALL METABOLOMICS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Maria T. Papadopoulou, Aristotle University Of Thessaloniki
Study Sponsor Aristotle University Of Thessaloniki
Collaborators Not Provided
Investigators
Study Chair: Athanassios Evangeliou, Prof Aristotle University Of Thessaloniki
PRS Account Aristotle University Of Thessaloniki
Verification Date January 2017