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

• Conditions: Acute Lymphoblastic Leukemia, Pediatric; Metabolism Disorder
• Interventions: Other: Metabolome study

• Registration Number: NCT03035344
• Lead Sponsor: Aristotle University Of Thessaloniki

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 Timeline

• Study Start: 2015-05
• Status Verified: 2017-01
• Study First Submitted: 2017-01-26
• Study First Submitted QC: 2017-01-26
• Last Update Submitted: 2017-01-26
• Study First Posted: 2017-01-30
• Last Update Posted: 2017-01-30
• Primary Completion: 2017-05
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ALL paediatric patients	Metabolome study	Metabolome study in children diagnosed with ALL after bone marrow biopsy
Healthy matched controls	Metabolome study	Metabolome study in healthy children matched for gender and age with the patients group

Primary Outcome Measures

Name	Time	Method
Difference in measurement of aminoacids and organic acids between ALL patients and healthy matched controls.	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

Trial Locations

Locations (1)

Aristotle University of Thessaloniki; 🇬🇷 Thessaloniki, Greece