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

Acute Lymphoblastic Leukemia, Pediatric Clinical Trial

Official title:

Study of the Intermediate Metabolism in Children With Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03035344
• Other study ID #: CHILDHOOD ALL METABOLOMICS
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2017
• Last updated: January 26, 2017
• Start date: May 2015
• Est. completion date: November 2018

Study information

• Verified date: January 2017
• Source: Aristotle University Of Thessaloniki
• Contact: Maria T. Papadopoulou, MD
• Phone: 6932343539
• Email: mtpapado[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Study of the intermediate metabolism in children diagnosed with ALL compared to healthy matched controls.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: November 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 16 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia, Pediatric
• Leukemia
• Leukemia, Lymphoid
• Metabolic Diseases
• Metabolism Disorder
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• Metabolome study
Metabolome study in ALL patients compared to healthy controls

Locations

Country	Name	City	State
Greece	Aristotle University of Thessaloniki	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in measurement of aminoacids and organic acids between ALL patients and healthy matched controls.	The title of aminoacids in blood and urine and of organic acids in urine will be measured through Tandem Mass Spectrometry	Up to six months