Leukemia, LymphoblasticNCT06110182
Evaluation of the Advantage in the Use of Enteral Nutrition in Children Treated for Acute Lymphoblastic Leukemia
An observational study of Leukemia, Lymphoblastic, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
This is a multicenter retrospective study (Reims and Nancy), with data collection over 12 years from 01/01/2010 to 12/31/2022 Patients included are children diagnosed with acute lymphoblastic leukemia between 2010 and 2021 in the 2 centers. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Leukemia, Lymphoblastic
- What is being tested?
- enteral or parenteral nutritional support
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2023to 1 May 2025
- 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 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children diagnosed with acute lymphoblastic leukemia between 2010 and 2021 in Nancy and Reims
Who may be able to join
- Children between 1 and 18 years old diagnosed with Medium risk/ High Risk B acute lymphoblastic leukemia or Standard/ High Risk T acute lymphoblastic leukemia between 2010 and 2021 in Nancy and Reims.
Who cannot join
- Patients less than 1 year old
- leukémia with philadelphia chromosome
- standard risk B acute lymphoblastic leukemia
- bone marrow transplant during treatment
- death during the year following diagnosis
- refusal of the patient (parents) to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
This is a multicenter retrospective study (Reims and Nancy), with data collection over 12 years from 01/01/2010 to 12/31/2022 Patients included are children diagnosed with acute lymphoblastic leukemia between 2010 and 2021 in the 2 centers.
Patients will be categorized into 3 groups:
Read more
- No nutritional support
- Support by enteral nutrition
- Parenteral nutrition support Their nutritional status will be assessed at the end of induction, at 6 months and then at 12 months from diagnosis.
The main objective of this study is therefore to compare the nutritional status of children with acute lymphoblastic leukemia depending on whether they received enteral or parenteral nutritional support during their treatment.
The secondary objective is to evaluate the occurrence of complications during treatment according to the nutritional support received.
- Conditions
- Leukemia, Lymphoblastic
- Being tested
- enteral or parenteral nutritional support
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral or parenteral nutritional supportDietary supplement
Parents will be classified based on whether they received enteral or parenteral nutritional support during treatment.
| Study group | Role | What they receive |
|---|---|---|
| enteral nutrition | children who received enteral nutritional support during treatment Receives: Dietary Supplement: enteral or parenteral nutritional support | |
| parenteral nutrition | children who received parenteral nutritional support during treatment Receives: Dietary Supplement: enteral or parenteral nutritional support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Z-score
Compare the improvement in Z-score between the date of diagnosis and 6 months from diagnosis in children using parenteral nutrition and those using enteral nutrition during treatment of their acute lymphoblastic leukemia
Measured: 6 months
Secondary outcomes (3)
BMI
Compare the improvement in BMI between the date of diagnosis and 6 months from diagnosis in children using parenteral nutrition and those using enteral nutrition during treatment of their acute lymphoblastic leukemia
Measured: 6 months
albumin
Compare the improvement in albumin level between the date of diagnosis and 6 months from diagnosis in children using parenteral nutrition and those using enteral nutrition during treatment of their acute lymphoblastic leukemia
Measured: 6 months
complications
Compare the percentages of occurrence of complications between the date of diagnosis and 6 months after diagnosis in children using parenteral nutrition and those using enteral nutrition during treatment for their acute lymphoblastic leukemia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Oct 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, LymphoblasticStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DEUTSCH Hélène, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110182
- Sponsor's protocol ID
- 2023_PI_069
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Advantage in the Use of Enteral Nutrition in Children Treated for Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT06110182
- Acronym / sponsor ID
- 2023_PI_069
- Conditions
- Leukemia, Lymphoblastic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 31 Oct 2023 (actual)
- 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.
This is a multicenter retrospective study (Reims and Nancy), with data collection over 12 years from 01/01/2010 to 12/31/2022 Patients included are children diagnosed with acute lymphoblastic leukemia between 2010 and 2021 in the 2 centers.
Patients will be categorized into 3 groups:
- No nutritional support
- Support by enteral nutrition
- Parenteral nutrition support Their nutritional status will be assessed at the end of induction, at 6 months and then at 12 months from diagnosis.
The main objective of this study is therefore to compare the nutritional status of children with acute lymphoblastic leukemia depending on whether they received enteral or parenteral nutritional support during their treatment.
The secondary objective is to evaluate the occurrence of complications during treatment according to the nutritional support received.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| enteral nutrition | – | Dietary Supplement: enteral or parenteral nutritional supportchildren who received enteral nutritional support during treatment |
| parenteral nutrition | – | Dietary Supplement: enteral or parenteral nutritional supportchildren who received parenteral nutritional support during treatment |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children diagnosed with acute lymphoblastic leukemia between 2010 and 2021 in Nancy and Reims
Key inclusion criteria (1 listed)
- Children between 1 and 18 years old diagnosed with Medium risk/ High Risk B acute lymphoblastic leukemia or Standard/ High Risk T acute lymphoblastic leukemia between 2010 and 2021 in Nancy and Reims.
Key exclusion criteria (6 listed)
- Patients less than 1 year old
- leukémia with philadelphia chromosome
- standard risk B acute lymphoblastic leukemia
- bone marrow transplant during treatment
- death during the year following diagnosis
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 |
|---|---|---|
| enteral or parenteral nutritional supportParents will be classified based on whether they received enteral or parenteral nutritional support during treatment. | Dietary supplement | enteral nutrition, parenteral nutrition |
Primary outcome
Z-score
Time frame: 6 months
Compare the improvement in Z-score between the date of diagnosis and 6 months from diagnosis in children using parenteral nutrition and those using enteral nutrition during treatment of their acute lymphoblastic leukemia
3 secondary outcomes
BMI
Time frame: 6 months
albumin
Time frame: 6 months
complications
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Leukemia, Lymphoblastic, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. 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 31 Oct 2023. 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 France. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Z-score (time frame: 6 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 31 Oct 2023.