Acute Lymphoblastic Leukemia, PediatricNCT03035344
Study of the Intermediate Metabolism in Children With Acute Lymphoblastic Leukemia (ALL)
An observational study of Acute Lymphoblastic Leukemia, Pediatric and Metabolism Disorder, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Study of the intermediate metabolism in children diagnosed with ALL compared to healthy matched controls. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Pediatric, Metabolism Disorder
- What is being tested?
- Metabolome study
- How many people
- 25 participants
- Where
- 1 siteGreece
- Study dates
- May 2015to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children diagnosed with acute lymphoblastic leukemia
- 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
Trial locations and contacts
1 site in 1 country.
Athanassios Evangeliou, Prof contact
Greece1 site, 1 recruiting
- Recruiting
Aristotle University of Thessaloniki
Thessaloniki
Maria T. Papadopoulou, MD, +306932343539, mtpapado@gmail.com
About this study
Official title: Study of the Intermediate Metabolism in Children With Acute Lymphoblastic Leukemia
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.
- Being tested
- Metabolome study
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolome studyOther
Metabolome study in ALL patients compared to healthy controls
| Study group | Role | What they receive |
|---|---|---|
| ALL paediatric patients | Metabolome study in children diagnosed with ALL after bone marrow biopsy Receives: Other: Metabolome study | |
| Healthy matched controls | Metabolome study in healthy children matched for gender and age with the patients group Receives: Other: Metabolome study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startMay 2015
- Primary completionMay 2017 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia, PediatricStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria T. Papadopoulou, Aristotle University Of Thessaloniki
- Investigators
- Athanassios Evangeliou, Prof, Study chair, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035344
- Sponsor's protocol ID
- CHILDHOOD ALL METABOLOMICS
- Status last verified
- Jan 2017
- First submitted
- 26 Jan 2017
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Intermediate Metabolism in Children With Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT03035344
- Acronym / sponsor ID
- CHILDHOOD ALL METABOLOMICS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALL paediatric patients | – | Other: Metabolome studyMetabolome study in children diagnosed with ALL after bone marrow biopsy |
| Healthy matched controls | – | Other: Metabolome studyMetabolome study in healthy children matched for gender and age with the patients group |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children diagnosed with acute lymphoblastic leukemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolome studyMetabolome study in ALL patients compared to healthy controls | Other | ALL paediatric patients, Healthy matched controls |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athanassios Evangeliou, Prof contact
Athanassios Evangeliou, Prof study chair
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, Pediatric and Metabolism Disorder, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria T. Papadopoulou, MD (6932343539, mtpapado@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in measurement of aminoacids and organic acids between ALL patients and healthy matched controls. (time frame: Up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.