InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort

NCT ID: NCT05929976

Last Updated: 2025-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

4900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-26

Study Completion Date

2029-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Lymphoblastic Leukemia Nutrition Aspect of Cancer Microtia Genetic Predisposition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

\- Patients receiving hematopoietic cell transplant.
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

International Agency for Research on Cancer

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Elena Ladas

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Columbia University Irving Medical Center

New York, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Hospital de Cancer Infanto Juvenil de Barretos

Barretos, , Brazil

Site Status RECRUITING

Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

Recife, , Brazil

Site Status RECRUITING

Instituto de Tratamento do Câncer Infantil (ITACI)

São Paulo, , Brazil

Site Status RECRUITING

Unidad Nacional De Oncologia Pediatrica

Guatemala City, , Guatemala

Site Status RECRUITING

Hospital Escuela

Tegucigalpa, , Honduras

Site Status RECRUITING

Post-Graduate Institute of Medical Education and Research (PGIMER)

Chandigarh, , India

Site Status RECRUITING

Muhumbili Hospital

Dar es Salaam, Dar es Salaam Region, Tanzania

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Brazil Guatemala Honduras India Tanzania

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Elena Ladas, PhD, RD

Role: CONTACT

+12123057835

Michelle Walters, MS, RD

Role: CONTACT

+12128514995

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mariana Mura

Role: primary

+55 17 3321-5400

Jullyana Alves

Role: primary

+55 81 99594-8420

Karina Viani, PhD, RD

Role: primary

+5511993038746

Federico Antillon Klussmann, MD

Role: primary

+50223289600

Ligia Fu

Role: primary

+504 2232-2322

Amita Trehan, MD

Role: primary

+91 172 274 7585

Primus Ewald

Role: primary

+255767944827

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AAAU1407

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Vaccine Immune Recovery After Leukemia
NCT05622682 ENROLLING_BY_INVITATION