ClinicalTrials.gg
RecruitingNCT07246213Updated Sep 29, 2026

CAYA Cancer Retrospective Cohort Study

An observational study in Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma and Young Adult Cancer, sponsored by Resonance, Inc.. Recruiting at 7 sites in 6 countries. Open to participants aged 0 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Resonance, Inc. · Observational

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 5 months later.
Updated Sep 29, 2026First sites in Egypt and TanzaniaSite recruiting status changed+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
18,000
Ages
0 Years to 21 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Acute Lymphoblastic Leukemia
  • Lymphoblastic Lymphoma
  • Young Adult Cancer
  • Adolescent Cancer
  • Childhood Cancers
  • Acute Lymphoblastic Leukemia (ALL)
  • Lymphoblastic Lymphoma (LBL)

Keywords

  • Cancer outcomes
  • Low- and Middle-Income Countries (LMICs)
  • Childhood cancer
  • Adolescent and young adult cancer (CAYA)
  • Treatment failure
  • Therapy-related toxicities
  • Retrospective cohort
  • Leukemia outcomes
  • Oncology disparities
  • High-Income Countries (HICs)
03

In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.

This study's planned enrollment of 18,000 is above the median of 108 across 400 observational studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

Resonance, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will comprise pediatric patients aged 0-21 years diagnosed with cancer, reflecting diverse demographic backgrounds and clinical characteristics.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Subjects must meet all the following criteria to be included in this registry:

  1. Participants must be willing and able to provide prior to enrollment in the registry.

    1. For minors or individuals unable to provide informed consent, assent must be obtained along with consent from a legal guardian.
    2. 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).
  2. A confirmed diagnosis of any type of cancer within the 15 years prior to the site's activation date.
  3. Age 0 to 21 years at the time of diagnosis.
  4. Received substantial anti-cancer treatment at the participating center, including but not limited to:

    1. Chemotherapy
    2. Surgery
    3. Radiation therapy
    4. Immunotherapy
  5. Medical records are available and accessible for review

Exclusion criteria

Exclusion Criteria:

  • Subjects meeting any of the following criteria will be excluded from this registry:

    1. Patients who only visited the participating center for:

      1. Consultation without subsequent primary anti-cancer treatment at the participating center
      2. Pathology, radiology, or other diagnostic evaluations without treatment
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
18,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • All Cancer Diagnoses

    Patients aged 0-21 years with any type of cancer diagnosis. Retrospective medical record review will capture incidence of treatment failure, including relapse, progression, or abandonment.

    Other: Retrospective Medical Record Review

  • Acute Lymphoblastic Leukemia / Lymphoblastic Lymphoma

    Patients aged 0-21 years diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma. Retrospective review will focus on therapy-related toxicities and treatment outcomes in this subgroup.

    Other: Retrospective Medical Record Review

Interventions

  • OtherRetrospective 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.

06

What researchers measure

Primary outcomes

  1. 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)

  2. To estimate the incidence of Grade 3, 4, and 5 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 outcomes

  1. 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)

  2. To estimate the event-free survival (EFS) and overall survival (OS) in patients diagnosed with any type of 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)

  3. 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)

  4. 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)

07

Study locations

5 of 7 sites recruiting
08

References and documents

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. PubMed 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. PubMed 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.2017.265. Epub 2017 Aug 18. PubMed 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. PubMed 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: 10.1016/S1470-2045(18)30123-2. PubMed 29726390 ↗

Individual participant data

Plan to share: 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.

09

Updates

1 registry update since Sep 25, 2026
Sites
2 sites added — first sites in Egypt and Tanzania. 3 sites changed recruiting status (3 now recruiting)
Show 3 sites
  • Fundación Ayúdame a Vivir · El Salvador, El SalvadorNot yet recruiting→Recruiting
  • Hospital Mario Catarino Rivas · San Pedro Sula, HondurasNot yet recruiting→Recruiting
  • Hospital Escuela · Tegucigalpa, HondurasNot yet recruiting→Recruiting
Show 2 added (1 Egypt, 1 Tanzania)
  • The Children's Cancer Hospital Egypt 57357 · Cairo, Egypt
  • Kilimanjaro Christian Medical Center · Moshi, Tanzania
Sep 29, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • EditedTo estimate the incidence of Grade 3, 4, and 5 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)
Sep 29, 2026
Secondary outcomes
1 edited
What changed in the outcomes
  • ChangedBefore To estimate the incidence and severity of individual therapy- related toxicities in patients diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma.Now To estimate the event-free survival (EFS) and overall survival (OS) in patients diagnosed with any type of 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)
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    2 sites added — first sites in Egypt and Tanzania. 3 sites changed recruiting status (3 now recruiting)
    Show 3 sites
    • Fundación Ayúdame a Vivir · El Salvador, El SalvadorNot yet recruiting→Recruiting
    • Hospital Mario Catarino Rivas · San Pedro Sula, HondurasNot yet recruiting→Recruiting
    • Hospital Escuela · Tegucigalpa, HondurasNot yet recruiting→Recruiting
    Show 2 added (1 Egypt, 1 Tanzania)
    • The Children's Cancer Hospital Egypt 57357 · Cairo, Egypt
    • Kilimanjaro Christian Medical Center · Moshi, Tanzania
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedTo estimate the incidence of Grade 3, 4, and 5 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 outcomes 1 edited
    What changed in the outcomes
    • ChangedBefore To estimate the incidence and severity of individual therapy- related toxicities in patients diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma.Now To estimate the event-free survival (EFS) and overall survival (OS) in patients diagnosed with any type of 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)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07246213
Lead sponsor
Resonance, Inc.
Collaborators
Servier Affaires Médicales
Responsible party
Sponsor
First posted
Nov 24, 2025
Start date
Jun 4, 2025
Primary completion
Jun 4, 2028 (estimated)
Completion
Dec 4, 2028 (estimated)
Last update
Sep 29, 2026

Study contacts

Gabriela Villanueva, MD.
Contact
gabriela.villanueva@resonancehealth.org
+1-901-205-9518

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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