Clinical trial · Observational
CAYA Cancer Prospective Cohort Study
Improving Cancer Outcomes for Children, Adolescents, and Young Adults: A Multicenter Prospective Cohort Study on Treatment Failure and Toxicity in Low- and Middle-Income Countries.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia (ALL) | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Lymphoblastic Lymphoma (LBL) | Lymphoblastic Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Children, Adolescents, and Young Adults With Cancer
- description
- 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 outcomes (1)
- measure
- Primary Outcome Measure
- timeFrame
- From enrollment through 36 months of follow-up
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (17)
- BACKGROUNDNath A, Mathur P, Sudarshan KL, Kaur Rajput G, Mascarenhas L, Arora RS, Seth R, Kumar Dixit S, Chinnaswamy G, Banipal RPS, Bhutia TW, Kumar Bodal V, Budukh A, Kumar Chaudhary N, Vijay CR, Shikha Das D, Gundeti S, Harris C, Hazarika M, Natha Jondhale S, Gunaseelan K, Khamo V, Konjengbam R, Kumar A, Saroj Kumar DM, Majumdar G, Malik S, Mandal S, Najmi AM, Mohan Kumar C, Kumar Pandey A, Pandya S, Pareek P, Pautu JL, Surya Rao V, Ramesh C, Rawal M, Radhakrishnan N, Radhakrishnan V, Shah A, Singh SB, Singh V, Singh P, Sundriyal D, Swaminathan R, Avinash T, Priya Kumari T, Tawsik S, Tiwari L. An assessment of childhood cancer care services in India - gaps, challenges and the way forward. Lancet Reg Health Southeast Asia. 2023 Jun 20;16:100235. doi: 10.1016/j.lansea.2023.100235. eCollection 2023 Sep. PMID 37694177
- BACKGROUNDVerma N, Bhattacharya S. Time to Diagnosis and Treatment of Childhood Cancer. Indian J Pediatr. 2020 Aug;87(8):641-643. doi: 10.1007/s12098-020-03217-y. Epub 2020 Feb 13. PMID 32056193
- BACKGROUNDBrown BJ, Ajayi SO, Ogun OA, Oladokun RE. Factors influencing time to diagnosis of childhood cancer in Ibadan, Nigeria. Afr Health Sci. 2009 Dec;9(4):247-53. PMID 21503176
- BACKGROUNDNjuguna F, Martijn H, Langat S, Musimbi J, Muliro H, Skiles J, Vik T, Sitaresmi MN, van de Ven PM, Kaspers GJ, Mostert S. Factors influencing time to diagnosis and treatment among pediatric oncology patients in Kenya. Pediatr Hematol Oncol. 2016 Apr;33(3):186-99. doi: 10.3109/08880018.2016.1169566. PMID 27184775
- BACKGROUNDCotache-Condor C, Kantety V, Grimm A, Williamson J, Landrum KR, Schroeder K, Staton C, Majaliwa E, Tang S, Rice HE, Smith ER. Determinants of delayed childhood cancer care in low- and middle-income countries: A systematic review. Pediatr Blood Cancer. 2023 Mar;70(3):e30175. doi: 10.1002/pbc.30175. Epub 2022 Dec 29. PMID 36579761
- BACKGROUNDBukowinski AJ, Burns KC, Parsons K, Perentesis JP, O'Brien MM. Toxicity of Cancer Therapy in Adolescents and Young Adults (AYAs). Semin Oncol Nurs. 2015 Aug;31(3):216-26. doi: 10.1016/j.soncn.2015.05.003. Epub 2015 May 7.