Aplastic Anemia Life-Course Cohort Study (TRACE-AA)
A Longitudinal Cohort Study of Aplastic Anemia Across the Disease Course
To establish a longitudinal cohort spanning the entire care continuum of acquired aplastic anemia (AA), from diagnosis and treatment through long-term follow-up, integrating routinely collected clinical data with biospecimens obtained in accordance with applicable ethical and regulatory requirements. The cohort will support observational studies of the natural history of AA; treatment effectiveness and safety; the evolution of clonal hematopoiesis and clonal T-cell populations; immune reconstitution following immunosuppressive therapy (IST); the incidence of platelet transfusion refractoriness and its association with response to IST; and hematopoietic and immune reconstitution after transplantation. Ultimately, the cohort aims to generate real-world evidence to inform clinical practice and reduce the burden of AA.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jun Shi, PhD
- Número de teléfono: 13752253515
- Correo electrónico: shijun@ihcams.ac.cn
Copia de seguridad de contactos de estudio
- Nombre: Jingyu Zhao, MPH
- Número de teléfono: 13752253515
- Correo electrónico: zhaojingyu@ihcams.ac.cn
Ubicaciones de estudio
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Porcelana, 301617
- Reclutamiento
- Red Blood Cell Diseases Center and Regenerative Medicine Center
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Contacto:
- Jun Shi, PhD
- Número de teléfono: 13752253515
- Correo electrónico: shijun@ihcams.ac.cn
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Patients receiving immunosuppressive therapy, allogeneic hematopoietic stem cell transplantation, or other treatments in routine clinical practice will be enrolled and followed longitudinally from diagnosis through long-term follow-up.
Descripción
Inclusion Criteria:
- Subjects diagnosed with primary acquired aplastic anemia.
- Subjects treated at the Institute of Hematology and Blood Diseases Hospital from Jan 1, 2012.
Exclusion Criteria:
- Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study.
- Subject unlikely to be available for long-term follow-up for any reason (e.g., inability to obtain follow-up data or presence of severe comorbidities).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: OTHER
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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TRACE-AA
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Data collected will include: demographic characteristics; medical history and environmental exposures; comorbidities and concomitant medications; medical records; treatment regimens; treatment-related adverse events; treatment outcomes; clonal hematopoiesis and clonal evolution; immune reconstitution; platelet transfusion refractoriness; clonal T-cell populations; quality of life; and health economic outcomes, including healthcare costs and length of hospital stay. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hematologic response
Periodo de tiempo: Assessments will be conducted at baseline, 6 months, 12 months, and 24 months after treatment, as well as at study completion, with an average interval of approximately 1 year.
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Hematologic response contains improvements in hemoglobin level, platelet count and neutrophil count. |
Assessments will be conducted at baseline, 6 months, 12 months, and 24 months after treatment, as well as at study completion, with an average interval of approximately 1 year.
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Clonal evolution
Periodo de tiempo: Assessments will be conducted at baseline, 6 months, 12 months, and 24 months after treatment, as well as at study completion, with an average interval of approximately 1 year.
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Progression to paroxysmal nocturnal hemoglobinuria, myelodysplastic syndrome, or acute myeloid leukemia. |
Assessments will be conducted at baseline, 6 months, 12 months, and 24 months after treatment, as well as at study completion, with an average interval of approximately 1 year.
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Treatment related adverse events
Periodo de tiempo: Within 10 years after allo-HSCT; within 6 months after IST
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The main treatment modalities include allogeneic hematopoietic stem cell transplantation (allo-HSCT) and intensive immunosuppressive therapy (IST). Use Common Terminology Criteria for Adverse Events (CTCAE) Version 6 to assess the adverse event |
Within 10 years after allo-HSCT; within 6 months after IST
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Jun Shi, PhD, Institute of Hematology & Blood Diseases Hosptial, Chinese Academy of Medical Science and Peking Union Medical School
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IIT2026131
Información sobre medicamentos y dispositivos, documentos del estudio
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