Leukemia, LymphoblasticNCT04271215
Overweight and Obesity as Prognostic Factors for Survival in Children With Acute Lymphoblastic Leukemia
An observational study of Leukemia, Lymphoblastic, run by Coordinación de Investigación en Salud, Mexico at 3 sites in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 15 years
- Conditions the study is for
- Leukemia, Lymphoblastic
- What is being tested?
- Chemotherapy protocol used
- How many people
- 1,200 participants
- Where
- 3 sitesMexico
- Study dates
- 1 Jan 2010to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Patients with Down Syndrome (for being a population with different disease behavior and cytogenetic alterations than patients without this genetic condition)
Trial locations and contacts
3 sites in 1 country.
Mexico3 sites
Centro Médico Nacional Hospital General La Raza, IMSS
Mexico City, 02990
Hospital General Regional Num 1 Carlos McGregor Sánchez Navarro, IMSS
Mexico City, 03103
Hospital de Pediatria "Dr. Silvestre Frenk Freund" CMN Siglo XXI, IMSS
Mexico City, 06720
About this study
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.
Read the detailed 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 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.
- Conditions
- Leukemia, Lymphoblastic
- Being tested
- Chemotherapy protocol used
- Keywords
- Overweight, Obesity, Survival, Children
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy protocol usedOther
Chemotherapy protocol used in each participating hospital
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chemotherapy protocol used |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.).
Measured: year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Jan 2010
- Primary completion31 Dec 2021
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leukemia, LymphoblasticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Juan Manuel Mejía Aranguré, Coordinación de Investigación en Salud, Mexico
- Investigators
- Juan M Mejía-Arangure, PhD, Principal investigator, Instituto Mexicano del Seguro Social/Instituto Nacional de Medicina Genomica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271215
- Sponsor's protocol ID
- R-2015-785-070
- Status last verified
- Jul 2022
- First submitted
- 11 Feb 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Ethics Committee asked for not making any individual participant data available
Publications
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.
PubMed 31319816
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overweight and Obesity as Prognostic Factors for Survival in Children With Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT04271215
- Acronym / sponsor ID
- R-2015-785-070
- Conditions
- Leukemia, Lymphoblastic
- Keywords
- Overweight, Obesity, Survival, Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overweight/Obesity | – | Other: Chemotherapy protocol usedBMI 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. |
Who may qualify
- Ages
- 1 day to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with Down Syndrome (for being a population with different disease behavior and cytogenetic alterations than patients without this genetic condition)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapy protocol usedChemotherapy protocol used in each participating hospital | Other | Overweight/Obesity |
Primary outcome
Overall survival
Time frame: 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.
Disease-free survival
Time frame: 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.).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Results publication: PubMed 31319816Nunez-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.
- Individual participant dataSharing planned: No. The Ethics Committee asked for not making any individual participant data available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan M Mejía-Arangure, PhD principal investigator
Instituto Mexicano del Seguro Social/Instituto Nacional de Medicina Genomica
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Lymphoblastic, run by Coordinación de Investigación en Salud, Mexico at 3 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: year 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04271215, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.