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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Jun Shi, PhD
- Telefoonnummer: 13752253515
- E-mail: shijun@ihcams.ac.cn
Studie Contact Back-up
- Naam: Jingyu Zhao, MPH
- Telefoonnummer: 13752253515
- E-mail: zhaojingyu@ihcams.ac.cn
Studie Locaties
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 301617
- Werving
- Red Blood Cell Diseases Center and Regenerative Medicine Center
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Contact:
- Jun Shi, PhD
- Telefoonnummer: 13752253515
- E-mail: shijun@ihcams.ac.cn
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: OTHER
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Hematologic response
Tijdsspanne: 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.
|
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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Jun Shi, PhD, Institute of Hematology & Blood Diseases Hosptial, Chinese Academy of Medical Science and Peking Union Medical School
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IIT2026131
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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