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NCT Number: NCT07246213

CAYA Cancer Retrospective Cohort Study

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Acute Lymphoblastic Leukemia (ALL) Adolescent Cancer Childhood Cancers Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoblastic Lymphoma Lymphoblastic Lymphoma (LBL) Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Young Adult Cancer

Age range

0 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yeolyan Center for Cancer and Blood Disorders, Yerevan, Armenia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retrospective Medical Record Review

Other

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 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 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 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)

  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)

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriela Villanueva, MD.

CONTACT

[email protected]

+1-901-205-9518

Sponsors and collaborators

Lead sponsor

Resonance, Inc.

Other

Collaborators

  • Servier Affaires Médicales

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 24, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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