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Status unknownNCT03035344Updated Jan 30, 2017

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

An observational study in Acute Lymphoblastic Leukemia, Pediatric and Metabolism Disorder, sponsored by Aristotle University Of Thessaloniki. Status unknown at 1 site in Greece. Open to participants aged 1 Month to 16 Years. Per ClinicalTrials.gov, last updated 2017-01-30.

Sponsored by Aristotle University Of Thessaloniki · Observational

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
25
Ages
1 Month to 16 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Acute Lymphoblastic Leukemia, Pediatric
  • Metabolism Disorder
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 25 is below the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Aristotle University Of Thessaloniki is the lead sponsor of 274 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children diagnosed with acute lymphoblastic leukemia

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • ALL paediatric patients

    Metabolome study in children diagnosed with ALL after bone marrow biopsy

    Other: Metabolome study

  • Healthy matched controls

    Metabolome study in healthy children matched for gender and age with the patients group

    Other: Metabolome study

Interventions

  • OtherMetabolome study

    Metabolome study in ALL patients compared to healthy controls

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to six months

07

Study locations

1 of 1 sites recruiting
  • Aristotle University of Thessaloniki
    Thessaloniki, Greece
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03035344
Lead sponsor
Aristotle University Of Thessaloniki
Responsible party
Maria T. Papadopoulou (Principal investigator, MD, PhD candidate, Aristotle University Of Thessaloniki) — Principal investigator
First posted
Jan 30, 2017
Start date
May 2015
Primary completion
May 2017 (estimated)
Completion
Nov 2018 (estimated)
Last update
Jan 30, 2017

Study contacts

Maria T. Papadopoulou, MD
Contact
mtpapado@gmail.com
6932343539
Athanassios Evangeliou, Prof
Contact
00302313323916
Athanassios Evangeliou, Prof
study chair · Aristotle University Of Thessaloniki

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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