CancerNCT07632014
CAYA Cancer Prospective Cohort Study
An observational study of Cancer and Pediatric Cancer, run by Resonance, Inc. at 6 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 21 years
- Conditions the study is for
- Cancer, Pediatric Cancer, Lymphoblastic Lymphoma (LBL)
- How many people
- 6,000 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 18 Sep 2026to 11 Nov 2032
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 5 countries
Honduras2 sites, 2 recruiting
- Not yet recruiting
Hospital Mario Catarino Rivas
San Pedro Sula
Roxana Martínez, MD, +504-94501075, roxmartinez@doctor.com
beckeratrox@gmail.com
- Not yet recruiting
Hospital Escuela
Tegucigalpa
Ligia Fu, MD, +50499926939, ligiafucarrasco@gmail.com
ligiafucarrasco@yahoo.com
Armenia1 site, 1 recruiting
- Not yet recruiting
Yeolyan Center for Cancer and Blood Disorders
Yerevan
Anna Avagyan, MD, +010283800, avagyananna2010@gmail.com
Egypt1 site, 1 recruiting
- Not yet recruiting
The Children's Cancer Hospital Egypt 57357
Cairo, 11441
Iman Sidhom, MD., (202) 25351500, iman.sidhom@57357.org
Alaa El Haddad, MD., (202) 25351500, Alaa.Hadad@57357.org
El Salvador1 site, 1 recruiting
- Not yet recruiting
Fundación Ayúdame a Vivir
San Salvador
Roberto Vasquez, MD, +503-901-263-5251, rfranklinvz@gmail.com
Guatemala1 site, 1 recruiting
- Recruiting
Unidad Nacional de Oncología Pediátrica (UNOP)
Guatemala City
Jeanine Alfaro, MD, 50223177800 ext. 502, jalfaroflowcyt@ayuvi.org.gt
About this study
Official title: 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.
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)
- Medical subject headings
- Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
- 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.
- 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.
Measured: From enrollment through 36 months of follow-up
Secondary outcomes (1)
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: Patient/family discontinuation against medical advice, or failure to return for scheduled treatment for ≥28 consecutive days without documented medical justification or known outcome (e.g., death, relapse, toxicity-related delay); summarized as percentage. Treatment interruptions: Delay >7 and <28 days in starting a subsequent treatment cycle per protocol; summarized as percentage.
Measured: From enrollment through 36 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start18 Sep 2026
- Primary completion11 Nov 2032 (estimated)
- Study completion11 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Resonance, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Servier Affaires Médicales
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632014
- Sponsor's protocol ID
- RES-NIT-102-25
- Status last verified
- Sep 2026
- First submitted
- 23 Apr 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 37694177Verma 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.
PubMed 32056193Brown 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.
PubMed 21503176Njuguna 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.
PubMed 27184775Cotache-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.
PubMed 36579761Bukowinski 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.
PubMed 26210200Bamodu 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.
PubMed 39173080Chan 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.
PubMed 39268694Ariello 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.
PubMed 39847745Ehrlich 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.
PubMed 37517410Rodriguez-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.
PubMed 26304881Li 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.
PubMed 39434099Derebas 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.
PubMed 35326719Temple 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.
PubMed 36907639Hu 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.
PubMed 39717082