CAYA Cancer Retrospective Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Retrospective Medical Record Review.
- Who it may be relevant to
- Registry conditions: Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Young Adult Cancer, Adolescent Cancer. Basic parameters: 0 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Armenia, El Salvador, Guatemala, Honduras
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Improving Cancer Outcomes for Children, Adolescents, and Young Adults: A Multicenter Retrospective Cohort Study on Treatment Failure and Toxicity in Low- and Middle-Income Countries
Overview
Despite advances in cancer treatment, significant disparities in outcomes persist between high-income countries (HICs) and low-and middle-income countries (LMICs). Around 80% of children with cancer live in LMICs, where they face challenges such as delayed diagnosis, misdiagnosis, comorbidities, distance to treatment, financial barriers, and limited access to risk-adapted therapies. Acute lymphoblastic leukemia(ALL)/lymphoblastic lymphoma(LBL), for example, is one of the greatest success stories in pediatric oncology, however, such improvements are not evenly distributed worldwide, and the outcomes for leukemia patients are poorer in LMICs compared to HICs, primarily due to reduced access to quality healthcare. This study aims to assess cancer treatment outcomes in LMICs, focusing on acute lymphoblastic leukemia/lymphoblastic lymphoma. The findings will inform future studies to implement evidence-based interventions that improve care quality and reduce treatment failures through targeted strategies.
Interventions
- Other Retrospective Medical Record Review
This study involves retrospective review of medical records of pediatric, adolescent, and young adult cancer patients (ages 0-21 years) treated at participating oncology centers in Guatemala, Honduras, El Salvador, Armenia, and Tanzania. No experimental drug, device, or behavioral intervention is being administered. Data abstraction will be performed to assess treatment failure, therapy-related toxicities, and clinical outcomes.
Primary outcome measures
- To estimate the incidence of treatment failure, in patients with any type of cancer diagnosis. [Time frame: 3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years)]
- To estimate the incidence of therapy related toxicities in patients diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma. [Time frame: 3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years)]
Secondary outcome measures (4)
- To estimate the incidence of treatment failure by cancer type, treatment regimen, age groups, and sociodemographic variables of patients diagnosed with any cancer. [Time frame: 3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years)]
- To estimate the incidence and severity of individual therapy- related toxicities in patients diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma. [Time frame: 3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years)]
- To estimate the event-free survival (EFS) and overall survival (OS) for patients diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma. [Time frame: 3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years)]
- To describe patterns of relapse in patients with acute lymphoblastic leukemia or lymphoblastic lymphoma. [Time frame: 3 years from date of cancer diagnosis (retrospective follow-up via medical records; patients without an event will be censored at last contact within 3 years)]
Eligibility criteria
Inclusion criteria
Subjects must meet all the following criteria to be included in this registry:
- Participants must be willing and able to provide informed consent prior to enrollment in the registry.
- For minors or individuals unable to provide informed consent, assent must be obtained along with consent from a legal guardian.
- Note: Exemption applies to this criterion when waiver of informed consent/assent is granted by Institutional Review Board(IRB)/Independent Ethics Committee(IEC)/Competent Authorities(CAs).
- A confirmed diagnosis of any type of cancer within the 15 years prior to the site's activation date.
- Age 0 to 21 years at the time of diagnosis.
- Received substantial anti-cancer treatment at the participating center, including but not limited to:
- Chemotherapy
- Surgery
- Radiation therapy
- Immunotherapy
- Medical records are available and accessible for review
Exclusion criteria
- Subjects meeting any of the following criteria will be excluded from this registry:
- Patients who only visited the participating center for:
- Consultation without subsequent primary anti-cancer treatment at the participating center
- Pathology, radiology, or other diagnostic evaluations without treatment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Honduras · 2 centers
- Hospital Mario Catarino Rivas — San Pedro Sula
- Hospital Escuela — Tegucigalpa
Armenia · 1 center
- Yeolyan Center for Cancer and Blood Disorders — Yerevan
El Salvador · 1 center
- Fundación Ayúdame a Vivir — El Salvador
Guatemala · 1 center
- Unidad Nacional de Oncología Pediátrica (UNOP) — Guatemala City
Publications
- 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
- Pui CH, Yang JJ, Bhakta N, Rodriguez-Galindo C. Global efforts toward the cure of childhood acute lymphoblastic leukaemia. Lancet Child Adolesc Health. 2018 Jun;2(6):440-454. doi: 10.1016/S2352-4642(18)30066-X. Epub 2018 Mar 30. PMID 30169285
- Toft N, Birgens H, Abrahamsson J, Griskevicius L, Hallbook H, Heyman M, Klausen TW, Jonsson OG, Palk K, Pruunsild K, Quist-Paulsen P, Vaitkeviciene G, Vettenranta K, Asberg A, Frandsen TL, Marquart HV, Madsen HO, Noren-Nystrom U, Schmiegelow K. Results of NOPHO ALL2008 treatment for patients aged 1-45 years with acute lymphoblastic leukemia. Leukemia. 2018 Mar;32(3):606-615. doi: 10.1038/leu.2017. PMID 28819280
- Chantada G, Lam CG, Howard SC. Optimizing outcomes for children with non-Hodgkin lymphoma in low- and middle-income countries by early correct diagnosis, reducing toxic death and preventing abandonment. Br J Haematol. 2019 Jun;185(6):1125-1135. doi: 10.1111/bjh.15785. Epub 2019 Feb 10. PMID 30740656
- Howard SC, Zaidi A, Cao X, Weil O, Bey P, Patte C, Samudio A, Haddad L, Lam CG, Moreira C, Pereira A, Harif M, Hessissen L, Choudhury S, Fu L, Caniza MA, Lecciones J, Traore F, Ribeiro RC, Gagnepain-Lacheteau A. The My Child Matters programme: effect of public-private partnerships on paediatric cancer care in low-income and middle-income countries. Lancet Oncol. 2018 May;19(5):e252-e266. doi: 10.1 PMID 29726390
Identifiers
NCT: NCT07246213 · RES-NIT-101-25