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Набор скоро начнётся NCT07577375

Prospective Validation of Engraftment Syndrome Phenotypes and Outcomes After Hematopoietic Stem Cell Transplantation

— Наблюдательное Engraftment Syndrome Allo-HSCT

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: No Intervention: Observational Cohort.
Кому может быть актуально
Состояния в реестре: Engraftment Syndrome, Allo-HSCT. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Другое No Intervention: Observational Cohort
    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.

Первичные конечные точки

  • Time to Grade II-IV Acute Graft-Versus-Host Disease [Срок оценки: 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.]
Вторичные конечные точки (6)
  • Incidence of Grade II-IV Acute Graft-Versus-Host Disease [Срок оценки: Up to 180 days after transplantation.]
  • Incidence of Chronic Graft-Versus-Host Disease [Срок оценки: Up to 2 years after transplantation.]
  • Overall Survival [Срок оценки: From transplantation to death from any cause, assessed up to 2 years after transplantation.]
  • Disease-Free Survival [Срок оценки: From transplantation to relapse, disease progression, or death from any cause, assessed up to 2 years after transplantation.]
  • Cumulative Incidence of Relapse [Срок оценки: Up to 2 years after transplantation.]
  • Non-Relapse Mortality [Срок оценки: Up to 2 years after transplantation.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07577375 · ES-HSCT-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗