Acute Lymphoblastic LeukemiaNICHENCT05929976
InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
An observational study of Acute Lymphoblastic Leukemia and Nutrition Aspect of Cancer, run by Columbia University at 8 sites in 6 countries.
Trial summary
Nutritional status is a measurable and modifiable factor that is often not considered during treatment and its clinical impact undervalued due in part to the heavy demands on clinicians in low and middle income countries to deliver therapy to large numbers of patients. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Nutrition Aspect of Cancer, Microtia
- How many people
- 4,900 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 26 Oct 2022to 1 Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents diagnosed with acute lymphoblastic leukemia
Who may be able to join
- Patients must be between 3 years and 18 years of age at time of assent/consent.
- Patients must have newly diagnosed B- or T-cell ALL, or mixed phenotype acute leukemia confirmed by pathology report.
- Patients must be receiving treatment at one of the participating centers.
Who cannot join
- Patients receiving hematopoietic cell transplant.
Trial locations and contacts
8 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 6 countries
Brazil3 sites, 3 recruiting
- Recruiting
Hospital de Cancer Infanto Juvenil de Barretos
Barretos
Mariana Mura, +55 17 3321-5400, marianamurra05@gmail.com
- Recruiting
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Recife
Jullyana Alves, +55 81 99594-8420, jullyana.alves@imip.org.br
- Recruiting
Instituto de Tratamento do Câncer Infantil (ITACI)
São Paulo
Karina Viani, PhD, RD, +5511993038746, karina.viani@hc.fm.usp.br
United States1 site
- Active, not recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Guatemala1 site, 1 recruiting
- Recruiting
Unidad Nacional De Oncologia Pediatrica
Guatemala City
Federico Antillon Klussmann, MD, +50223289600, fantillo@ufm.edu
Honduras1 site, 1 recruiting
- Recruiting
Hospital Escuela
Tegucigalpa
Ligia Fu, +504 2232-2322, ligiafucarrasco@yahoo.com
India1 site, 1 recruiting
- Recruiting
Post-Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh
Amita Trehan, MD, +91 172 274 7585, amita911@gmail.com
Tanzania1 site, 1 recruiting
- Recruiting
Muhumbili Hospital
Dar es Salaam, Dar es Salaam Region
Primus Ewald, +255767944827, drprimus@wearetlm.org
About this study
Official title: Multi-National Nutritional Biobanking Program in Pediatric Oncology InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
Nutritional status is a measurable and modifiable factor that is often not considered during treatment and its clinical impact undervalued due in part to the heavy demands on clinicians in low and middle income countries to deliver therapy to large numbers of patients. The proposed study will create a biobank of clinical data and biological specimens which will foster future studies on cancer progression and prognosis as well as toxicities during treatment which may impact survivorship and late-effects. Eligible patients must be between 3 years and 18 years of age at time of assent/consent, have newly diagnosed B- or T-cell acute lymphoblastic leukemia or mixed phenotype acute leukemia confirmed by pathology report, and must be receiving treatment at one of the participating centers. Patients receiving hematopoietic cell transplant will be excluded. Institutions were selected to ensure representation of several global health indicators related to nutritional status and wealth classification according to the World Bank. Data related to demographic variables (socioeconomic status, food security), lifestyle habits (diet, physical activity), nutritional anthropometrics (height, weight and arm anthropometry), and nutritional biological indices (stool and blood) will be collected at designated timepoints throughout treatment and one year after the end of treatment.
- Conditions
- Acute Lymphoblastic Leukemia, Nutrition Aspect of Cancer, Microtia, Genetic Predisposition
- Being tested
- No intervention
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Congenital Microtia, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Create a prospective multinational biorepository of pediatric specimens (stool, blood) obtained at diagnosis, end of induction, beginning of maintenance, end of treatment, and 1-year after treatment among children/adolescents with ALL.
Measured: 7 years
Collect sociodemographic data at sequential timepoints during treatment for ALL.
Measured: 7 years
Collect dietary data at sequential timepoints during treatment for ALL.
Measured: 7 years
Collect physical activity data at sequential timepoints during treatment for ALL.
Measured: 7 years
Collect clinical information (disease characteristics, treatment-related toxicities, survival) at sequential timepoints during treatment for ALL to accompany the biorepository of blood and stool specimens.
Measured: 7 years
Collect nutritional anthropometrics at sequential timepoints during treatment for ALL to accompany the biorepository of blood and stool specimens.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start26 Oct 2022
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Prospective
- Enrolment
- 4,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- International Agency for Research on Cancer
- Responsible party
- Principal investigator, Elena Ladas, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929976
- Sponsor's protocol ID
- AAAU1407
- Acronym
- NICHE
- Status last verified
- Jul 2025
- First submitted
- 15 Jun 2023
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-National Nutritional Biobanking Program in Pediatric Oncology InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
- ClinicalTrials.gov ID
- NCT05929976
- Acronym / sponsor ID
- NICHE / AAAU1407
- Conditions
- Acute Lymphoblastic Leukemia, Nutrition Aspect of Cancer, Microtia, Genetic Predisposition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,900 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- International Agency for Research on Cancer
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 5 Jul 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.
Nutritional status is a measurable and modifiable factor that is often not considered during treatment and its clinical impact undervalued due in part to the heavy demands on clinicians in low and middle income countries to deliver therapy to large numbers of patients. The proposed study will create a biobank of clinical data and biological specimens which will foster future studies on cancer progression and prognosis as well as toxicities during treatment which may impact survivorship and late-effects. Eligible patients must be between 3 years and 18 years of age at time of assent/consent, have newly diagnosed B- or T-cell acute lymphoblastic leukemia or mixed phenotype acute leukemia confirmed by pathology report, and must be receiving treatment at one of the participating centers. Patients receiving hematopoietic cell transplant will be excluded. Institutions were selected to ensure representation of several global health indicators related to nutritional status and wealth classification according to the World Bank. Data related to demographic variables (socioeconomic status, food security), lifestyle habits (diet, physical activity), nutritional anthropometrics (height, weight and arm anthropometry), and nutritional biological indices (stool and blood) will be collected at designated timepoints throughout treatment and one year after the end of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents diagnosed with acute lymphoblastic leukemia
Key inclusion criteria (3 listed)
- Patients must be between 3 years and 18 years of age at time of assent/consent.
- Patients must have newly diagnosed B- or T-cell ALL, or mixed phenotype acute leukemia confirmed by pathology report.
- Patients must be receiving treatment at one of the participating centers.
Key exclusion criteria (1 listed)
- Patients receiving hematopoietic cell transplant.
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 |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Create a prospective multinational biorepository of pediatric specimens (stool, blood) obtained at diagnosis, end of induction, beginning of maintenance, end of treatment, and 1-year after treatment among children/adolescents with ALL.
Time frame: 7 years
Collect sociodemographic data at sequential timepoints during treatment for ALL.
Time frame: 7 years
Collect dietary data at sequential timepoints during treatment for ALL.
Time frame: 7 years
Collect physical activity data at sequential timepoints during treatment for ALL.
Time frame: 7 years
Collect clinical information (disease characteristics, treatment-related toxicities, survival) at sequential timepoints during treatment for ALL to accompany the biorepository of blood and stool specimens.
Time frame: 7 years
Collect nutritional anthropometrics at sequential timepoints during treatment for ALL to accompany the biorepository of blood and stool specimens.
Time frame: 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No
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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.
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia and Nutrition Aspect of Cancer, run by Columbia University at 8 sites in 6 countries.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Brazil, United States, Guatemala, Honduras, India and 1 more country. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Ladas, PhD, RD (+12123057835, ejd14@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Create a prospective multinational biorepository of pediatric specimens (stool, blood) obtained at diagnosis, end of induction, beginning of maintenance, end of treatment, and 1-year after treatment among children/adolescents with ALL. (time frame: 7 years). The study lists 6 primary outcomes in all. 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 22 Jul 2025.