An observational study in Cancer, Pediatric Cancer and Lymphoblastic Lymphoma (LBL), sponsored by Resonance, Inc.. Recruiting at 3 sites in 3 countries. Open to participants aged 0 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Resonance, Inc. · Observational
Cancer is a leading cause of illness and death among children, adolescents, and young adults(CAYAs), especially in low- and middle-income countries(LMICs), where access to timely diagnosis and treatment is often limited. As a result, patients in these settings may experience higher rates of treatment complications, interruptions, and poorer outcomes compared with those in high-income countries (HICs).
This is a prospective, multicenter observational study that will follow children, adolescents, and young adults(CAYAs) with cancer who are receiving routine care at participating hospitals in low - and middle - income countries(LMICs). The study does not involve experimental treatments or changes to standard medical care. Information will be collected from medical records and from questionnaires that address access to care and social factors affecting treatment.
By describing treatment outcomes and the challenges patients and families face during cancer care, this study aims to provide data that can help inform future efforts to improve access to care and cancer outcomes in resource-limited settings.
The study population consists of children, adolescents and young adults aged 0 to 21 years diagnosed with cancer, who are receiving routine clinical care at participating hospitals in low- and middle-income countries(LMIC). Participants are enrolled prospectively and followed over time as part of an observational cohort to document clinical outcomes and factors related to access to care.
Subjects must meet all the following criteria to be included in this study:
Diagnosed with cancer and receiving active treatment or undergoing follow-up at the participating sites.
a. Note: Patients seen solely for consultation or diagnostic evaluations without subsequent treatment and those who have been off treatment for more than 5 years and are seen only for survivorship follow-up are not considered as meeting this criterion.
Exclusion Criteria:
Subjects meeting any of the following criteria must be excluded from this study:
1. Any medical or psychological condition that, in the investigator's opinion, might compromise the ability of the patient to provide assent/informed consent/assent.
Participants include children, adolescents and young adults with a diagnosis of cancer who are receiving routine care at participating hospitals in low- and middle-income countries(LMIC). This study follows patients as part of a single observational cohort and does not assign any experimental treatments. All medical care is provided according to local standard practice. Participants are followed over time to document clinical outcomes, as well as factors related to access to care and the overall treatment experience.
Primary Outcome Measure
1. Incidence of treatment failure, dichotomous: Defined as the first occurrence of relapse, progressive disease, refractory disease, treatment-related death, diseaserelated death, treatment abandonment, or secondary malignancy; summarized as the 3-year cumulative incidence of the event. 2. Incidence of severe treatment-related toxicity (CTCAE v5.0), dichotomous: Defined as the first occurrence of any grade 3, 4 or 5 adverse event according to CTCAE 5.0; summarized as the 3-year cumulative incidence of the event.
Time frame: From enrollment through 36 months of follow-up
Secondary Outcome Measures
Event free survival (EFS), dichotomous time-to-event: First occurrence of death, relapse, progressive disease, refractory disease, treatment abandonment, or secondary malignancy; summarized as the 3-year EFS. Overall survival (OS), dichotomous time-to-event: Occurrence of death; summarized as the 3-year OS. Pattern of relapse, categorical: Site of disease recurrence after a complete remission, classified as isolated bone marrow, isolated CNS, isolated extramedullary, or combined relapse, or no recurrence, whichever occurs first, summarized as the percentage of each category. Treatment abandonment, dichotomous: Period of 4 weeks or more without receiving any protocol-specified therapy by patient/family decision; summarized as percentage. Treatment interruptions, dichotomous: Period of more than 7 days and less than 4 weeks in the initiation of a subsequent treatment cycle as specified by the treatment protocol; summarized as percentage.
Time frame: From enrollment through 36 months of follow-up
Other Outcome Measures
Total interval, numerical discrete: Defined as the time in days from the onset of the first symptom to the start of anti-cancer treatment; summarized as median time and interquartile range (IQR). Patient interval, numerical discrete: Defined as the time in days from the onset of the first cancer symptom to the first consultation with a healthcare professional; summarized as median time and IQR. Diagnostic interval, numerical discrete: Defined as the time in days from the first consultation with a healthcare professional to the date of a definitive cancer diagnosis; summarized as median time and IQR. Treatment interval, numerical discrete: Defined as the time in days from the date of a definitive cancer diagnosis to the day of starting anti-cancer treatment; summarized as median time and IQR.
Time frame: From enrollment through 36 months of follow up.
Plan to share: Undecided — At this stage, the plan for sharing individual participant data (IPD) remains undecided. As the study continues to expand to new sites and additional countries, a comprehensive assessment of applicable data protection and privacy regulations in each jurisdiction is required. A final determination regarding IPD sharing will be made once compliance with all relevant national and international legal frameworks has been ensured.
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Resonance, Inc.