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NCT05929976 · ClinicalTrials.gov registry record

InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort

A clinical trial of Acute Lymphoblastic Leukemia and Genetic Predisposition, sponsored by Columbia University.

Recruiting
Registry status
4,900
Enrollment target
8
Study locations

NCT05929976 is a study of Acute Lymphoblastic Leukemia and Genetic Predisposition that is actively recruiting participants, run by Columbia University. The registered enrollment target is 4,900 participants, above the 345-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (1320% higher). The trial reports 8 study locations across 3 states.

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The verdict

NCT05929976, a study of Acute Lymphoblastic Leukemia and Genetic Predisposition, is actively recruiting participants, sponsored by Columbia University.

RECRUITING
Registry status
4,900 participants
Enrollment target
8
Study locations

Study 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. 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.

Interventions

  • OTHER No intervention

Study Locations (8)

Other

  • Hospital de Cancer Infanto Juvenil de Barretos - Barretos
  • Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) - Recife
  • Instituto de Tratamento do Câncer Infantil (ITACI) - São Paulo
  • Unidad Nacional De Oncologia Pediatrica - Guatemala City
  • Hospital Escuela - Tegucigalpa
  • Post-Graduate Institute of Medical Education and Research (PGIMER) - Chandigarh

New York

  • Columbia University Irving Medical Center - New York

Dar es Salaam Region

  • Muhumbili Hospital - Dar es Salaam

Trial Details

FieldValue
Enrollment Target 4,900 participants
Start Date 2022-10-26
Est. Completion 2029-10-01

Sponsor

Columbia University

958 total trials

What the Registry Record Tells You About NCT05929976

The ClinicalTrials.gov registry entry for NCT05929976 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 4,900 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 345-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (1320% higher). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which No intervention is the first listed.

NCT05929976 reports 8 study locations spanning 3 distinct geographic areas - top geographies include Other, New York, Dar es Salaam Region.

Frequently Asked Questions

What is clinical trial NCT05929976 about?

NCT05929976 is a clinical study titled "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...

What is the current status of trial NCT05929976?

This trial is currently recruiting. The enrollment target is 4,900 participants. The study started on 2022-10-26. Estimated completion is 2029-10-01.

What conditions does trial NCT05929976 study?

This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Genetic Predisposition, Microtia, Nutrition Aspect of Cancer.

What interventions are being tested in trial NCT05929976?

The interventions under investigation include: No intervention (OTHER).

Who is sponsoring clinical trial NCT05929976?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05929976 being conducted?

This trial has 8 study locations across New York, Dar es Salaam Region. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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