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

Sponsor
Aristotle University Of Thessaloniki (Other)
Overall Status
Unknown status
CT.gov ID
NCT03035344
Collaborator
(none)
25
Enrollment
1
Location
42.1
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Metabolome study

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 Design

Study Type:
Observational
Anticipated Enrollment :
25 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Study of the Intermediate Metabolism in Children With Acute Lymphoblastic Leukemia
Study Start Date :
May 1, 2015
Anticipated Primary Completion Date :
May 1, 2017
Anticipated Study Completion Date :
Nov 1, 2018

Arms and Interventions

Arm Intervention/Treatment
ALL paediatric patients

Metabolome study in children diagnosed with ALL after bone marrow biopsy

Other: Metabolome study
Metabolome study in ALL patients compared to healthy controls
Healthy matched controls

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aristotle University of Thessaloniki Thessaloniki Greece

Sponsors and Collaborators

  • Aristotle University Of Thessaloniki

Investigators

  • Study Chair: Athanassios Evangeliou, Prof, Aristotle University Of Thessaloniki

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maria T. Papadopoulou, Principal investigator, MD, PhD candidate, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT03035344
Other Study ID Numbers:
  • CHILDHOOD ALL METABOLOMICS
First Posted:
Jan 30, 2017
Last Update Posted:
Jan 30, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Metabolic Diseases

Study Results

No Results Posted as of Jan 30, 2017