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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT03035344
Date of registration:	26/01/2017
Prospective Registration:	No
Primary sponsor:	Aristotle University Of Thessaloniki
Public title:	Study of the Intermediate Metabolism in Children With Acute Lymphoblastic Leukemia (ALL)
Scientific title:	Study of the Intermediate Metabolism in Children With Acute Lymphoblastic Leukemia
Date of first enrolment:	May 2015
Target sample size:	25
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT03035344
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment
Greece

Contacts

Name:	Maria T. Papadopoulou, MD
Address:
Telephone:	+306932343539
Email:	mtpapado@gmail.com
Affiliation:

Name:	Maria T. Papadopoulou, MD
Address:
Telephone:	6932343539
Email:	mtpapado@gmail.com
Affiliation:

Name:	Athanassios Evangeliou, Prof
Address:
Telephone:
Email:
Affiliation:	Aristotle University Of Thessaloniki

Key inclusion & exclusion 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

Age minimum: 1 Month
Age maximum: 16 Years
Gender: All

Health Condition(s) or Problem(s) studied

Metabolism Disorder

Acute Lymphoblastic Leukemia, Pediatric

Intervention(s)

Other: Metabolome study

Primary Outcome(s)

Difference in measurement of aminoacids and organic acids between ALL patients and healthy matched controls. [Time Frame: Up to six months]

Secondary Outcome(s)

Secondary ID(s)

CHILDHOOD ALL METABOLOMICS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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