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CAYA Cancer Prospective Cohort Study

3 de junio de 2026 actualizado por: Resonance, Inc.

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.

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Tipo de estudio

De observación

Inscripción (Estimado)

6000

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Armenia
      • Yerevan, Armenia
        • Reclutamiento
        • Yeolyan Center for Cancer and Blood Disorders
        • Contacto:
  • Egipto
      • Cairo, Egipto, 11441
        • Reclutamiento
        • The Children's Cancer Hospital Egypt 57357
        • Contacto:
        • Contacto:
          • Alaa El Haddad, MD.
          • Número de teléfono: (202) 25351500
          • Correo electrónico: Alaa.Hadad@57357.org
  • Guatemala
      • Guatemala City, Guatemala
        • Reclutamiento
        • Unidad Nacional de Oncología Pediátrica (UNOP)
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

The study population consists of children, adolescents and young adults aged 0 to 21 years diagnosed with cancer, who are receiving routine clinical care at participating hospitals in low- and middle-income countries(LMIC). Participants are enrolled prospectively and followed over time as part of an observational cohort to document clinical outcomes and factors related to access to care.

Descripción

Inclusion Criteria:

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

  1. Age 0 to 21 years at study enrollment.

  2. 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.

  3. 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:

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Children, Adolescents, and Young Adults With Cancer
Participants include children, adolescents and young adults with a diagnosis of cancer who are receiving routine care at participating hospitals in low- and middle-income countries(LMIC). This study follows patients as part of a single observational cohort and does not assign any experimental treatments. All medical care is provided according to local standard practice. Participants are followed over time to document clinical outcomes, as well as factors related to access to care and the overall treatment experience.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Primary Outcome Measure
Periodo de tiempo: From enrollment through 36 months of follow-up
  1. 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.
  2. 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.
From enrollment through 36 months of follow-up

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Secondary Outcome Measures
Periodo de tiempo: 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.
From enrollment through 36 months of follow-up

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Other Outcome Measures
Periodo de tiempo: 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.
From enrollment through 36 months of follow up.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Resonance, Inc.

Colaboradores

Servier Affaires Médicales

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de noviembre de 2025

Finalización primaria (Estimado)

11 de noviembre de 2032

Finalización del estudio (Estimado)

11 de noviembre de 2032

Fechas de registro del estudio

Enviado por primera vez

23 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de junio de 2026

Publicado por primera vez (Actual)

8 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • RES-NIT-102-25

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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