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NCT Number: NCT07632014

CAYA Cancer Prospective Cohort Study

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.

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Key information

Conditions

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

Age range

0 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yeolyan Center for Cancer and Blood Disorders, Yerevan, Armenia

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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 study:

  • Age 0 to 21 years at study enrollment.
  • Diagnosed with cancer and receiving active treatment or undergoing follow-up at the participating sites.

a. 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.

Exclusion criteria

Subjects meeting any of the following criteria must be excluded from this study:

  • Any medical or psychological condition that, in the investigator's opinion, might compromise the ability of the patient to provide assent/informed consent/assent.

Treatment and study plan

Primary outcomes

  1. Primary Outcome Measure

    Time frame: From enrollment through 36 months of follow-up

    • 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.

Secondary outcomes

  1. Secondary Outcome Measures

    Time frame: From enrollment through 36 months of follow-up

    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, dichotomous: Period of 4 weeks or more without receiving any protocol-specified therapy by patient/family decision; summarized as percentage.

    Treatment interruptions, dichotomous: Period of more than 7 days and less than 4 weeks in the initiation of a subsequent treatment cycle as specified by the treatment protocol; summarized as percentage.

Other outcomes

  1. Other Outcome Measures

    Time frame: From enrollment through 36 months of follow up.

    Total interval, numerical discrete: Defined as the time in days from the onset of the first symptom to the start of anti-cancer treatment; summarized as median time and interquartile range (IQR).

    Patient interval, numerical discrete: Defined as the time in days from the onset of the first cancer symptom to the first consultation with a healthcare professional; summarized as median time and IQR.

    Diagnostic interval, numerical discrete: Defined as the time in days from the first consultation with a healthcare professional to the date of a definitive cancer diagnosis; summarized as median time and IQR.

    Treatment interval, numerical discrete: Defined as the time in days from the date of a definitive cancer diagnosis to the day of starting anti-cancer treatment; summarized as median time and IQR.

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 Prospective Cohort Study on Treatment Failure and Toxicity in Low- and Middle-Income Countries.

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

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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