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- Ensayo clínico NCT04271215
Overweight and Obesity as Prognostic Factors for Survival in Children With Acute Lymphoblastic Leukemia
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 chemotherapy protocol is collected from the patients' clinical charts by previously standardized staff. Overcrowding was used as a proxy for socioeconomic status (SES) according to the Bronfman's criteria (high SES, up to 1.5 people per room; medium-low SES, more than 1.6 people per room). The risk classification is according to the criteria of the National Cancer Institute (NCI): standard risk [ages from 1 to 9.99 years; WBC count < 50 × 109/L] or as high risk [age < 1 or ≥ 10 years or WBC ≥ 50 × 109/L].
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 chemotherapy protocol). A Cox proportional hazard model will be used. Hazard ratios (HR) with 95% CIs will be calculated.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Mexico City, México, 02990
- Centro Médico Nacional Hospital General La Raza, IMSS
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Mexico City, México, 03103
- Hospital General Regional Num 1 Carlos McGregor Sánchez Navarro, IMSS
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Mexico City, México, 06720
- Hospital de Pediatria "Dr. Silvestre Frenk Freund" CMN Siglo XXI, IMSS
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with Down Syndrome (for being a population with different disease behavior and cytogenetic alterations than patients without this genetic condition)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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.
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Chemotherapy protocol used in each participating hospital
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Overall survival
Periodo de tiempo: year 5
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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.
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year 5
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Disease-free survival
Periodo de tiempo: year 5
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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.).
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year 5
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Juan M Mejía-Arangure, PhD, Instituto Mexicano del Seguro Social/Instituto Nacional de Medicina Genomica
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Sobrenutrición
- Trastornos Nutricionales
- Peso corporal
- Obesidad
- Leucemia
- Exceso de peso
- Leucemia-linfoma linfoblástico de células precursoras
- Leucemia Linfoide
Otros números de identificación del estudio
- R-2015-785-070
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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Ensayos clínicos sobre Chemotherapy protocol used
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Boston University Charles River CampusNational Institute of Mental Health (NIMH)TerminadoTrastorno límite de la personalidadEstados Unidos