CAYA Cancer Prospective Cohort Study

NCT07632014 | Recruiting

• 1 other identifier: RES-NIT-102-25
• Study Type: observational
• Target: 6,000
• Locations: 3 countries
• Sites: 3

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.

Conditions

Cancer; Pediatric Cancer; Lymphoblastic Lymphoma (LBL); Acute Lymphoblastic Leukemia (ALL)

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)

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment through 36 months of follow-up

Secondary Outcomes (1)

• Secondary Outcome Measures

  From enrollment through 36 months of follow-up

Other Outcomes (1)

• Other Outcome Measures

  From enrollment through 36 months of follow up.

Study Arms (1)

Children, Adolescents, and Young Adults With Cancer

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.

Eligibility Criteria

• Age: 0 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Subjects must meet all the following criteria to be included in this study:
• Age 0 to 21 years at study enrollment.
• 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.
• 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.

You may not qualify if:

• Subjects meeting any of the following criteria must be excluded from this study:
• \. Any medical or psychological condition that, in the investigator's opinion, might compromise the ability of the patient to provide assent/informed consent/assent.

Sponsors & Collaborators

• Resonance, Inc.: lead
• Servier Affaires Médicales: collaborator

Study Sites (3)

Yeolyan Center for Cancer and Blood Disorders

Yerevan, Armenia

RECRUITING

The Children's Cancer Hospital Egypt 57357

Cairo, 11441, Egypt

RECRUITING

Unidad Nacional de Oncología Pediátrica (UNOP)

Guatemala City, Guatemala

RECRUITING

Related Publications (17)

• Nath 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 BACKGROUND

• Verma 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 BACKGROUND

• Brown 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 BACKGROUND

• Njuguna 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 BACKGROUND

• Cotache-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 BACKGROUND

• Bukowinski 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.

  PMID: 26210200 BACKGROUND

• Bamodu OA, Chung CC. Cancer Care Disparities: Overcoming Barriers to Cancer Control in Low- and Middle-Income Countries. JCO Glob Oncol. 2024 Aug;10:e2300439. doi: 10.1200/GO.23.00439.

  PMID: 39173080 BACKGROUND

• Chan A, Eng L, Jiang C, Dagsi M, Ke Y, Tanay M, Bergerot C, Dixit N, Gutierrez AC, Velazquez AI, Islami F, Soto-Perez-de-Celis E. Global disparities in cancer supportive care: An international survey. Cancer Med. 2024 Sep;13(17):e70234. doi: 10.1002/cam4.70234.

  PMID: 39268694 BACKGROUND

• Ariello K, Hadi AN, Denburg A, Gupta S. Survival Outcomes for Adolescent and Young Adults With Cancer in Low- and Middle-Income Countries: A Systematic Review. JCO Glob Oncol. 2025 Jan;11:e2400326. doi: 10.1200/GO-24-00326. Epub 2025 Jan 23.

  PMID: 39847745 BACKGROUND

• Ehrlich BS, McNeil MJ, Pham LTD, Chen Y, Rivera J, Acuna C, Sniderman L, Sakaan FM, Aceituno AM, Villegas CA, Force LM, Bolous NS, Wiphatphumiprates PP, Slone JS, Carrillo AK, Gillipelli SR, Duffy C, Arias AV, Devidas M, Rodriguez-Galindo C, Mukkada S, Agulnik A. Treatment-related mortality in children with cancer in low-income and middle-income countries: a systematic review and meta-analysis. Lancet Oncol. 2023 Sep;24(9):967-977. doi: 10.1016/S1470-2045(23)00318-2. Epub 2023 Jul 27.

  PMID: 37517410 BACKGROUND

• Rodriguez-Galindo C, Friedrich P, Alcasabas P, Antillon F, Banavali S, Castillo L, Israels T, Jeha S, Harif M, Sullivan MJ, Quah TC, Patte C, Pui CH, Barr R, Gross T. Toward the Cure of All Children With Cancer Through Collaborative Efforts: Pediatric Oncology As a Global Challenge. J Clin Oncol. 2015 Sep 20;33(27):3065-73. doi: 10.1200/JCO.2014.60.6376. Epub 2015 Aug 24.

  PMID: 26304881 BACKGROUND

• Li W, Liang H, Wang W, Liu J, Liu X, Lao S, Liang W, He J. Global cancer statistics for adolescents and young adults: population based study. J Hematol Oncol. 2024 Oct 21;17(1):99. doi: 10.1186/s13045-024-01623-9.

  PMID: 39434099 BACKGROUND

• Derebas J, Panuciak K, Margas M, Zawitkowska J, Lejman M. The New Treatment Methods for Non-Hodgkin Lymphoma in Pediatric Patients. Cancers (Basel). 2022 Mar 18;14(6):1569. doi: 10.3390/cancers14061569.

  PMID: 35326719 BACKGROUND

• Temple WC, Mueller S, Hermiston ML, Burkhardt B. Diagnosis and management of lymphoblastic lymphoma in children, adolescents and young adults. Best Pract Res Clin Haematol. 2023 Mar;36(1):101449. doi: 10.1016/j.beha.2023.101449. Epub 2023 Feb 16.

  PMID: 36907639 BACKGROUND

• Hu Y, Liu Y, Fu J, Liu Y, Wang H, Song Y. Global, regional, and national burden of acute lymphoblastic leukemia in children: Epidemiological trends analysis from 1990 to 2021. iScience. 2024 Nov 23;27(12):111356. doi: 10.1016/j.isci.2024.111356. eCollection 2024 Dec 20.

  PMID: 39717082 BACKGROUND

• Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.

  PMID: 38572751 BACKGROUND

• Bray F, Laversanne M, Weiderpass E, Soerjomataram I. The ever-increasing importance of cancer as a leading cause of premature death worldwide. Cancer. 2021 Aug 15;127(16):3029-3030. doi: 10.1002/cncr.33587. Epub 2021 Jun 4.

  PMID: 34086348 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Gabriela Villanueva, MD.

CONTACT

+1-901-205-9518; gabriela.villanueva@resonancehealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: June 8, 2026
• Study Start: November 11, 2025
• Primary Completion (Estimated): November 11, 2032
• Study Completion (Estimated): November 11, 2032
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

AR (1); GU (1); EG (1)