Prospective Validation of Engraftment Syndrome Phenotypes and Outcomes After Hematopoietic Stem Cell Transplantation (ES after HSCT)
2026年5月3日 更新者：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.
調査の概要
研究の種類
観察的
入学 (推定)
250
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Yejun Wu
- 電話番号：+8618800181620
- メール：wyejun1999@163.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
なし
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to Grade II-IV Acute Graft-Versus-Host Disease
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Grade II-IV Acute Graft-Versus-Host Disease
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Severity-Oriented Engraftment Syndrome Phenotype
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
協力者
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2028年6月1日
研究の完了 (推定)
2029年6月1日
試験登録日
最初に提出
2026年5月3日
QC基準を満たした最初の提出物
2026年5月3日
最初の投稿 (実際)
2026年5月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月11日
QC基準を満たした最後の更新が送信されました
2026年5月3日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- ES-HSCT-001
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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