About this trial
Despite advances in cancer treatment, significant disparities in outcomes persist between high-income countries (HICs) and low-and middle-income countries (LMICs). Around 80% of children with cancer live in LMICs, where they face challenges such as delayed diagnosis, misdiagnosis, comorbidities, distance to treatment, financial barriers, and limited access to risk-adapted therapies.
Acute lymphoblastic leukemia(ALL)/lymphoblastic lymphoma(LBL), for example, is one of the greatest success stories in pediatric oncology, however, such improvements are not evenly distributed worldwide, and the outcomes for leukemia patients are poorer in LMICs compared to HICs, primarily due to reduced access to quality healthcare.
This study aims to assess cancer treatment outcomes in LMICs, focusing on acute lymphoblastic leukemia/lymphoblastic lymphoma. The findings will inform future studies to implement evidence-based interventions that improve care quality and reduce treatment failures through targeted strategies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must be willing and able to provide informed consent prior to enrollment in the registry.
For minors or individuals unable to provide informed consent, assent must be obtained along with consent from a legal guardian.
Note: Exemption applies to this criterion when waiver of informed consent/assent is granted by Institutional Review Board(IRB)/Independent Ethics Committee(IEC)/Competent Authorities(CAs).
A confirmed diagnosis of any type of cancer within the 15 years prior to the site's activation date.
Disqualifiers
Consultation without subsequent primary anti-cancer treatment at the participating center
Pathology, radiology, or other diagnostic evaluations without treatment
Trial population
The study population will comprise pediatric patients aged 0-21 years diagnosed with cancer, reflecting diverse demographic backgrounds and clinical characteristics.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Retrospective Medical Record Review
Other interventionThis study involves retrospective review of medical records of pediatric, adolescent, and young adult cancer patients (ages 0-21 years) treated at participating oncology centers in Guatemala, Honduras, El Salvador, Armenia, and Tanzania. No experimental drug, device, or behavioral intervention is being administered. Data abstraction will be performed to assess treatment failure, therapy-related toxicities, and clinical outcomes.
Treatment groups
Trial outcomes
Primary outcomes
To estimate the incidence of treatment failure, in patients with any type of cancer diagnosis.
To estimate the incidence of therapy related toxicities in patients diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma.
Secondary outcomes
To estimate the incidence of treatment failure by cancer type, treatment regimen, age groups, and sociodemographic variables of patients diagnosed with any cancer.
To estimate the incidence and severity of individual therapy- related toxicities in patients diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma.
To estimate the event-free survival (EFS) and overall survival (OS) for patients diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma.
To describe patterns of relapse in patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.
Sponsors and contacts
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Resonance, Inc.
Lead sponsor
Servier Affaires Médicales
Collaborator