Acute Lymphoblastic Leukemia (ALL), Cancer, Lymphoblastic Lymphoma (LBL), Pediatric Cancer
Conditions
Keywords
Children, Adolescents, and Young Adults (CAYA), Low- and middle-income countries (LMIC), Observational Study, Cancer Outcomes, Treatment-Related Toxicity, Treatment Failure, Treatment Abandonment, Diagnostic Delay, Socioeconomic Factors, High-income countries (HICs), Central Nervous System(CNS)
Brief summary
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.
Interventions
None listed
Sponsors
Resonance, Inc.
Servier Affaires Médicales
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet all the following criteria to be included in this study: 1. Age 0 to 21 years at study enrollment. 2. 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. 3. Willingness to provide informed consent/assent. For minors incapable of providing assent, or individuals unable to provide consent, consent must be obtained from a legal representative and in accordance with local requirements.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure | From enrollment through 36 months of follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome Measures | From enrollment through 36 months of follow-up | 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. |
Countries
Armenia, Egypt, Guatemala
Contacts
CONTACTGabriela Villanueva, MD.
Outcome results
None listed