Overweight and Obesity as Prognostic Factors for Survival in Children With Acute Lymphoblastic Leukemia

NCT04271215 | Unknown

• 1 other identifier: R-2015-785-070
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 3

Brief Summary

Background: Mexico City has one of the highest incidences and mortality rates of acute lymphoblastic leukemia (ALL) in the world and a high frequency of early relapses (17%) and early mortality (15%). Otherwise, childhood overweight and obesity are reaching epidemic proportions. They have been associated with poor outcomes in children with ALL. The aim of present study is to identify if overweight and obesity are prognostic factors associated with survival rates in Mexican children with ALL. Methods: Multicenter cohort study. ALL children younger than 15 years old are included and followed-up. Overweight and obesity are classified according World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) criteria. Deaths and relapses are the main outcomes.

Conditions

Leukemia, Lymphoblastic

Keywords

Overweight; Obesity; Survival; Children

Outcome Measures

Primary Outcomes (2)

• Overall survival

  Deaths of patients occurring during the follow-up period will be collected. The cause of death and the date that this occurred will be also registered. In the case of patients alive at the end of follow-up, the date of the last visit to the hospital will be collected.

  year 5

• Disease-free survival

  Clinical data and by complementary examinations indicating that there is reappearance of the disease after complete remission has been achieved, presence of blasts \> 5% in bone marrow (bone marrow relapse) or presence of blasts in cerebrospinal fluid fluid (CNS relapse), testicular infiltration by blasts in the biopsy (testicular relapse), combined (bone marrow/CNS) at any time during treatment . In case the patient has relapsed, the site of relapse will be collected (bone marrow, CNS, testicle, ovary, eye, etc.).

  year 5

Study Arms (1)

Overweight/Obesity

BMI at diagnosis will be used. Using WHO software (version 3.2.2, World Health Organization, Geneva), the BMI-for-age Z-scores were calculated for each patient. According to WHO classification, patients were categorized as normal (- 1.9999 to 0.9999), wasted (- 2 to - 2.9999), severely wasted (≥ - 3), at risk of overweight (1-1.9999), overweight (2 to 2.9999) and obesity (≥3). In addition, the BMI percentiles cutoffs provided by CDC were: normal (p5-84.9999), underweight (\< p5), overweight (p85-94.9999), and obese (≥ p95). The nutritional classification and measurements regarding weight and height recorded in clinical files will be used to classify patients' nutritional status in present research has been previously described.

Other: Chemotherapy protocol used

Interventions

Chemotherapy protocol used OTHER

Chemotherapy protocol used in each participating hospital

Overweight/Obesity

Eligibility Criteria

• Age: 1 Day - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study variables and data will be collected from the clinical files. The information collected by the surveyors will be delivered weekly to our Research Unit, where the field work coordinators will be in charge of assigning them a folio number, reviewing the collection instrument and passing it on to the personnel in charge of capturing the information. In addition, the fieldwork coordinators will supervise the collection of information, the search for files in the archive, the capture of information and will be responsible for keeping the project's database up to date.

You may qualify if:

• Patients under 15 years of age
• Newly diagnosed with acute lymphoblastic leukemia
• Diagnosis confirmation by bone marrow aspiration and immunophenotype
• Attended in the participating Hospitals.

You may not qualify if:

• \- Patients with Down Syndrome (for being a population with different disease behavior and cytogenetic alterations than patients without this genetic condition)

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (3)

Centro Médico Nacional Hospital General La Raza, IMSS

Mexico City, 02990, Mexico

Location

Hospital General Regional Num 1 Carlos McGregor Sánchez Navarro, IMSS

Mexico City, 03103, Mexico

Location

Hospital de Pediatria "Dr. Silvestre Frenk Freund" CMN Siglo XXI, IMSS

Mexico City, 06720, Mexico

Location

Related Publications (1)

• Nunez-Enriquez JC, Gil-Hernandez AE, Jimenez-Hernandez E, Fajardo-Gutierrez A, Medina-Sanson A, Flores-Lujano J, Espinoza-Hernandez LE, Duarte-Rodriguez DA, Amador-Sanchez R, Penaloza-Gonzalez JG, Torres-Nava JR, Espinosa-Elizondo RM, Flores-Villegas LV, Merino-Pasaye LE, Perez-Saldivar ML, Dorantes-Acosta EM, Cortes-Herrera B, Solis-Labastida KA, Nunez-Villegas NN, Velazquez-Avina MM, Rangel-Lopez A, Gonzalez-Avila AI, Santillan-Juarez JD, Garcia-Velazquez AJ, Jimenez-Morales S, Bekker-Mendez VC, Rosas-Vargas H, Mata-Rocha M, Sepulveda-Robles OA, Martin-Trejo JA, Mejia-Arangure JM. Overweight and obesity as predictors of early mortality in Mexican children with acute lymphoblastic leukemia: a multicenter cohort study. BMC Cancer. 2019 Jul 18;19(1):708. doi: 10.1186/s12885-019-5878-8.

  PMID: 31319816 RESULT

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Overweight; Obesity

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan M Mejía-Arangure, PhD

  Instituto Mexicano del Seguro Social/Instituto Nacional de Medicina Genomica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Research Linkage Area

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 17, 2020
• Study Start: January 1, 2010
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (3)