Prospective Validation of Engraftment Syndrome Phenotypes and Outcomes After Hematopoietic Stem Cell Transplantation (ES after HSCT)
2026년 5월 3일 업데이트: Xiao Hui Zhang
A Prospective Observational Cohort Study to Validate Engraftment Syndrome Phenotypes and Their Associations With Acute Graft-Versus-Host Disease and Clinical Outcomes After Hematopoietic Stem Cell Transplantation
Engraftment syndrome (ES) is an early inflammatory complication after hematopoietic stem cell transplantation (HSCT) and has been associated with subsequent transplant-related complications and adverse clinical outcomes. However, ES is clinically heterogeneous, and its relationship with acute graft-versus-host disease (aGVHD), survival, and other post-transplant outcomes remains incompletely defined.
This prospective observational cohort study aims to validate previously identified ES-associated risk factors, severity-oriented ES phenotypes, and their associations with grade II-IV aGVHD and clinical outcomes after HSCT. Patients undergoing HSCT will be prospectively followed for the development of ES, grade II-IV aGVHD, and clinical outcomes including overall survival, disease-free survival, relapse, and non-relapse mortality. The study will evaluate whether ES phenotypes and ES-related clinical characteristics can stratify patients according to subsequent aGVHD risk and post-transplant prognosis.
연구 개요
연구 유형
관찰
등록 (추정된)
250
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Yejun Wu
- 전화번호: +8618800181620
- 이메일: wyejun1999@163.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
해당 없음
샘플링 방법
비확률 샘플
연구 인구
The study population will include patients who develop engraftment syndrome after allogeneic hematopoietic stem cell transplantation at the participating center.
Patients will be prospectively enrolled after the diagnosis of engraftment syndrome and followed for subsequent grade II-IV acute graft-versus-host disease and post-transplant outcomes, including overall survival, disease-free survival, relapse, and non-relapse mortality.
Clinical features, laboratory parameters, engraftment kinetics, and organ-injury markers related to engraftment syndrome will be collected to validate ES phenotypes and their prognostic significance.
설명
Inclusion Criteria:
- Patients undergoing allogeneic hematopoietic stem cell transplantation at the participating center.
- Development of engraftment syndrome after hematopoietic stem cell transplantation, diagnosed according to predefined institutional or published clinical criteria.
- Availability of key clinical and laboratory data required for engraftment syndrome phenotyping, including engraftment kinetics, clinical manifestations, inflammatory markers, and organ-injury parameters.
- Ability to undergo prospective follow-up for post-transplant outcomes, including acute graft-versus-host disease and survival outcomes.
- Written informed consent provided by the patient or legally authorized representative, when required by the institutional review board or ethics committee.
Exclusion Criteria:
- Patients who do not develop engraftment syndrome after hematopoietic stem cell transplantation.
- Patients with insufficient clinical or laboratory data to confirm the diagnosis of engraftment syndrome.
- Patients with missing essential follow-up information for assessment of primary outcome measures.
- Patients who withdraw consent or decline participation in prospective follow-up.
- Patients enrolled in another study that, in the opinion of the investigators, may interfere with the observational assessment of engraftment syndrome phenotypes or post-transplant outcomes.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Patients With Engraftment Syndrome
Patients who develop engraftment syndrome after hematopoietic stem cell transplantation will be enrolled and prospectively followed.
Engraftment syndrome will be diagnosed according to predefined clinical criteria during the early post-transplant period.
Clinical features, laboratory parameters, transplant-related characteristics, ES phenotypes, subsequent grade II-IV acute graft-versus-host disease, and clinical outcomes will be recorded and analyzed.
|
No study-specific intervention will be administered.
Participants will receive standard clinical care after hematopoietic stem cell transplantation according to institutional practice and treating physician discretion.
The study will prospectively collect observational data on engraftment syndrome characteristics, laboratory parameters, subsequent grade II-IV acute graft-versus-host disease, and clinical outcomes.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to Grade II-IV Acute Graft-Versus-Host Disease
기간: From hematopoietic stem cell transplantation to the first diagnosis of grade II-IV acute graft-versus-host disease, assessed up to 180 days after transplantation.
|
Time from hematopoietic stem cell transplantation to the first diagnosis of grade II-IV acute graft-versus-host disease among patients with engraftment syndrome.
Acute graft-versus-host disease will be graded according to institutional standard criteria.
|
From hematopoietic stem cell transplantation to the first diagnosis of grade II-IV acute graft-versus-host disease, assessed up to 180 days after transplantation.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of Grade II-IV Acute Graft-Versus-Host Disease
기간: Up to 180 days after transplantation.
|
Proportion of participants who develop grade II-IV acute graft-versus-host disease after hematopoietic stem cell transplantation.
|
Up to 180 days after transplantation.
|
|
Incidence of Chronic Graft-Versus-Host Disease
기간: Up to 2 years after transplantation.
|
Proportion of participants who develop chronic graft-versus-host disease after hematopoietic stem cell transplantation.
|
Up to 2 years after transplantation.
|
|
Overall Survival
기간: From transplantation to death from any cause, assessed up to 2 years after transplantation.
|
Time from hematopoietic stem cell transplantation to death from any cause.
Participants alive at the last follow-up will be censored.
|
From transplantation to death from any cause, assessed up to 2 years after transplantation.
|
|
Disease-Free Survival
기간: From transplantation to relapse, disease progression, or death from any cause, assessed up to 2 years after transplantation.
|
Time from hematopoietic stem cell transplantation to relapse, disease progression, or death from any cause, whichever occurs first.
|
From transplantation to relapse, disease progression, or death from any cause, assessed up to 2 years after transplantation.
|
|
Cumulative Incidence of Relapse
기간: Up to 2 years after transplantation.
|
Proportion of participants who experience relapse or disease progression after hematopoietic stem cell transplantation.
Non-relapse death will be considered a competing event in competing-risk analyses.
|
Up to 2 years after transplantation.
|
|
Non-Relapse Mortality
기간: Up to 2 years after transplantation.
|
Death without prior relapse or disease progression after hematopoietic stem cell transplantation.
Relapse will be considered a competing event in competing-risk analyses.
|
Up to 2 years after transplantation.
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Severity-Oriented Engraftment Syndrome Phenotype
기간: From transplantation to 100 days after transplantation.
|
Classification of participants into severity-oriented engraftment syndrome phenotypes based on prospectively collected engraftment kinetics, pulmonary involvement, inflammatory burden, and organ-injury markers.
|
From transplantation to 100 days after transplantation.
|
|
Association Between Engraftment Syndrome Phenotype and Grade II-IV Acute Graft-Versus-Host Disease
기간: Engraftment syndrome phenotype assessed up to 100 days after transplantation; grade II-IV acute graft-versus-host disease assessed up to 180 days after transplantation.
|
Association between severity-oriented engraftment syndrome phenotype and subsequent development of grade II-IV acute graft-versus-host disease.
|
Engraftment syndrome phenotype assessed up to 100 days after transplantation; grade II-IV acute graft-versus-host disease assessed up to 180 days after transplantation.
|
|
Association Between Engraftment Syndrome Phenotype and Overall Survival
기간: Engraftment syndrome phenotype assessed up to 100 days after transplantation; overall survival assessed up to 2 years after transplantation.
|
Association between severity-oriented engraftment syndrome phenotype and overall survival after hematopoietic stem cell transplantation.
|
Engraftment syndrome phenotype assessed up to 100 days after transplantation; overall survival assessed up to 2 years after transplantation.
|
|
Association Between Engraftment Syndrome Phenotype and Disease-Free Survival
기간: Engraftment syndrome phenotype assessed up to 100 days after transplantation; disease-free survival assessed up to 2 years after transplantation.
|
Association between severity-oriented engraftment syndrome phenotype and disease-free survival after hematopoietic stem cell transplantation.
|
Engraftment syndrome phenotype assessed up to 100 days after transplantation; disease-free survival assessed up to 2 years after transplantation.
|
|
Performance of an Engraftment Syndrome Risk Stratification Model
기간: Predictors assessed up to 100 days after transplantation; outcomes assessed up to 2 years after transplantation.
|
Discrimination and calibration of a risk stratification model based on engraftment syndrome-related clinical features and laboratory parameters for predicting post-transplant outcomes.
|
Predictors assessed up to 100 days after transplantation; outcomes assessed up to 2 years after transplantation.
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
협력자
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 1일
기본 완료 (추정된)
2028년 6월 1일
연구 완료 (추정된)
2029년 6월 1일
연구 등록 날짜
최초 제출
2026년 5월 3일
QC 기준을 충족하는 최초 제출
2026년 5월 3일
처음 게시됨 (실제)
2026년 5월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 3일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- ES-HSCT-001
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
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아니
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