Study of the Intermediate Metabolism in Children With Acu... | NCT03035344

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

NCT03035344

Sponsor

Aristotle University Of Thessaloniki

Status

Unknown status

Last Update Posted

Jan 30, 2017Estimated

Enrollment

25Estimated

Phase

Not provided

Conditions

Acute Lymphoblastic Leukemia, Pediatric
Metabolism Disorder

Interventions

Metabolome study

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

May 2017Estimated

Completion Date

Nov 2018Estimated

First Submitted Date

Jan 26, 2017

First Submission Date that Met QC Criteria

Jan 26, 2017

First Posted Date

Jan 30, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2017

Last Update Posted Date

Jan 30, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maria T. Papadopoulou, Principal investigator, MD, PhD candidate, Aristotle University Of ThessalonikiPrincipal Investigator

Lead Sponsor

Aristotle University Of ThessalonikiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Metabolome study	Other	Metabolome study in ALL patients compared to healthy controls	ALL paediatric patients Healthy matched controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

16 Years

Standard Ages

Child

Study Population

Children diagnosed with acute lymphoblastic leukemia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maria T. Papadopoulou, MD	Contact	6932343539		mtpapado@gmail.com
Athanassios Evangeliou, Prof	Contact	00302313323916

Overall Officials

Name	Affiliation	Role
Athanassios Evangeliou, Prof	Aristotle University Of Thessaloniki	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aristotle University of Thessaloniki	Recruiting	Thessaloniki			Greece

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D008659	Metabolic Diseases

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided