- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04271215
Overweight and Obesity as Prognostic Factors for Survival in Children With Acute Lymphoblastic Leukemia
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
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Mexico City, Mexiko, 02990
- Centro Médico Nacional Hospital General La Raza, IMSS
-
Mexico City, Mexiko, 03103
- Hospital General Regional Num 1 Carlos McGregor Sánchez Navarro, IMSS
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Mexico City, Mexiko, 06720
- Hospital de Pediatria "Dr. Silvestre Frenk Freund" CMN Siglo XXI, IMSS
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
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.
|
Chemotherapy protocol used in each participating hospital
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Overall survival
Tidsram: year 5
|
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
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Disease-free survival
Tidsram: year 5
|
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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Juan M Mejía-Arangure, PhD, Instituto Mexicano del Seguro Social/Instituto Nacional de Medicina Genomica
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- R-2015-785-070
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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