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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Jun Shi, PhD
- Numero di telefono: 13752253515
- Email: shijun@ihcams.ac.cn
Backup dei contatti dello studio
- Nome: Jingyu Zhao, MPH
- Numero di telefono: 13752253515
- Email: zhaojingyu@ihcams.ac.cn
Luoghi di studio
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Cina, 301617
- Reclutamento
- Red Blood Cell Diseases Center and Regenerative Medicine Center
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Contatto:
- Jun Shi, PhD
- Numero di telefono: 13752253515
- Email: shijun@ihcams.ac.cn
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: OTHER
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Hematologic response
Lasso di tempo: 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.
|
|
Clonal evolution
Lasso di tempo: 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.
|
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
Lasso di tempo: 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
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Jun Shi, PhD, Institute of Hematology & Blood Diseases Hosptial, Chinese Academy of Medical Science and Peking Union Medical School
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IIT2026131
Informazioni su farmaci e dispositivi, documenti di studio
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