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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Jun Shi, PhD
- Numéro de téléphone: 13752253515
- E-mail: shijun@ihcams.ac.cn
Sauvegarde des contacts de l'étude
- Nom: Jingyu Zhao, MPH
- Numéro de téléphone: 13752253515
- E-mail: zhaojingyu@ihcams.ac.cn
Lieux d'étude
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Chine, 301617
- Recrutement
- Red Blood Cell Diseases Center and Regenerative Medicine Center
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Contact:
- Jun Shi, PhD
- Numéro de téléphone: 13752253515
- E-mail: shijun@ihcams.ac.cn
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: OTHER
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hematologic response
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Jun Shi, PhD, Institute of Hematology & Blood Diseases Hosptial, Chinese Academy of Medical Science and Peking Union Medical School
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IIT2026131
Informations sur les médicaments et les dispositifs, documents d'étude
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