Overweight and Obesity as Prognostic Factors for Survival in Children With Acute Lymphoblastic Leukemia
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- STATUS
- Recruiting
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- participants needed
- 1200
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- sponsor
- Coordinación de Investigación en Salud, Mexico
Summary
Background: Mexico City has one of the highest incidences and mortality rates of acute
Description
Data collection Information regarding sex, age at diagnosis, place of residence, white blood
cell (WBC) count, immunophenotype (B or T lineage), weight and height (length when
appropriate) at diagnosis, and
Assessment of nutritional status at diagnosis of ALL 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 validation regarding weight and height recorded in clinical files used to classify patients' nutritional status in present research has been previously described. Underweight patients were excluded from the analyses.
Sample size The sample size calculation was performed using Epi-Info version 7 software taking into account a mortality outcome frequency of 10.8% in the unexposed group (normal weight patients) and a death outcome frequency of 24% for the exposed (obese/overweight patients), a statistical power of 80% and a confidence of 95%; resulting in a total "n" of 350 overweight/obese patients to be compared with the rest of the cohort that are not overweight and obese.
Statistical analysis Descriptive statistics and relative risks (RR) calculation with 95%
confidence intervals (CI) will be carried out. Kaplan-Meier survival analysis will be
conducted. Log-rank test will be calculated. The analyses will be conducted independently for
disease-free-survival (DFS) or overall survival (OS), adjusting for variables whose effects
on the studied outcomes have been previously documented (age, sex, socioeconomic status,
immunophenotype, NCI risk classification, and
Details
Condition |
Lymphoid |
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Age | 15years or below |
Treatment |
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Clinical Study Identifier | NCT04271215 |
Sponsor | Coordinación de Investigación en Salud, Mexico |
Last Modified on | 19 February 2024 |
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