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.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Jun Shi, PhD
- 전화번호: 13752253515
- 이메일: shijun@ihcams.ac.cn
연구 연락처 백업
- 이름: Jingyu Zhao, MPH
- 전화번호: 13752253515
- 이메일: zhaojingyu@ihcams.ac.cn
연구 장소
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Tianjin Municipality
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Tianjin, Tianjin Municipality, 중국, 301617
- 모병
- Red Blood Cell Diseases Center and Regenerative Medicine Center
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연락하다:
- Jun Shi, PhD
- 전화번호: 13752253515
- 이메일: shijun@ihcams.ac.cn
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: OTHER
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hematologic response
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Jun Shi, PhD, Institute of Hematology & Blood Diseases Hosptial, Chinese Academy of Medical Science and Peking Union Medical School
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .