Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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

Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia, Pediatric Metabolism Disorder 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.

Layout table for study information
Study Type : Observational
Estimated 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 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : November 2018


Group/Cohort 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




Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
blood, urine, bone marrow


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Month to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children diagnosed with acute lymphoblastic leukemia
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035344


Contacts
Layout table for location contacts
Contact: Maria T. Papadopoulou, MD 6932343539 mtpapado@gmail.com
Contact: Athanassios Evangeliou, Prof 00302313323916

Locations
Layout table for location information
Greece
Aristotle University of Thessaloniki Recruiting
Thessaloniki, Greece
Contact: Maria T. Papadopoulou, MD    +306932343539    mtpapado@gmail.com   
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Layout table for investigator information
Study Chair: Athanassios Evangeliou, Prof Aristotle University Of Thessaloniki

Layout table for additonal information
Responsible Party: Maria T. Papadopoulou, Principal investigator, MD, PhD candidate, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT03035344     History of Changes
Other Study ID Numbers: CHILDHOOD ALL METABOLOMICS
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Metabolic Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases