NCT07246213

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jun 2025

Typical duration for all trials

Geographic Reach
4 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Jun 2025Dec 2028

Study Start

First participant enrolled

June 4, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2028

Last Updated

December 19, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

November 17, 2025

Last Update Submit

December 12, 2025

Conditions

Keywords

Cancer outcomesLow- and Middle-Income Countries (LMICs)Childhood cancerAdolescent and young adult cancer (CAYA)Treatment failureTherapy-related toxicitiesRetrospective cohortLeukemia outcomesOncology disparitiesHigh-Income Countries (HICs)

Outcome Measures

Primary Outcomes (2)

  • To estimate the incidence of treatment failure, in patients with any type of cancer diagnosis.

    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.

    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 (4)

  • To estimate the incidence of treatment failure by cancer type, treatment regimen, age groups, and sociodemographic variables of patients diagnosed with any cancer.

    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.

    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.

    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.

    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)

Study Arms (2)

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

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.

Acute Lymphoblastic Leukemia / Lymphoblastic LymphomaAll Cancer Diagnoses

Eligibility Criteria

Age0 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Yeolyan Center for Cancer and Blood Disorders

Yerevan, Armenia

RECRUITING

Fundación Ayúdame a Vivir

El Salvador, El Salvador, 1101, El Salvador

NOT YET RECRUITING

Unidad Nacional de Oncología Pediátrica (UNOP)

Guatemala City, Guatemala

RECRUITING

Hospital Mario Catarino Rivas

San Pedro Sula, Cortés Department, 21102, Honduras

NOT YET RECRUITING

Hospital Escuela

Tegucigalpa, Distrito Central, 11101, Honduras

NOT YET RECRUITING

Related Publications (5)

  • 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: 26304881BACKGROUND
  • 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: 30169285BACKGROUND
  • 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.

    PMID: 28819280BACKGROUND
  • 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: 30740656BACKGROUND
  • 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.

    PMID: 29726390BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaNeoplasms

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 24, 2025

Study Start

June 4, 2025

Primary Completion (Estimated)

June 4, 2028

Study Completion (Estimated)

December 4, 2028

Last Updated

December 19, 2025

Record last verified: 2025-08

Locations