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Идёт набор NCT06399302

Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes

— Наблюдательное Lung Transplant; Complications Lung Transplant; Infection or Inflammation Lung Transplant Rejection Lung Transplant Failure

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Lung Transplant; Complications, Lung Transplant; Infection or Inflammation, Lung Transplant Rejection, Lung Transplant Failure. Базовые параметры: от 18 лет · 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
США, Канада
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

Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes: PROMISE-Lung Study

Обзор

This project aims to collect detailed clinical data, blood samples, and patient-reported outcomes from 2,600 lung transplant candidates, donors, and recipients at Lung Transplant Centers. The goal is to create a robust resource for various research objectives, including studying the impact of variations in donor and medical practices on clinical outcomes. The project also seeks to identify serum biomarkers associated with or predictive of specific post-transplant complications and conditions.

Подробное описание

This is an observational, prospective, multicenter cohort study of 2,600 lung transplant donors and adult (18 years and older) lung transplant candidates and recipients that will collect longitudinal clinical data, and serial biological (blood) specimens and PROs to support a broad range of clinical and translational future research. Data and biospecimens will be rigorously collected and monitored to ensure high quality future studies that will address unmet needs and optimal management at each stage of the transplant journey from listing, to donor selection, to postoperative management. Subjects are recruited to the study either prior to undergoing lung transplant at the time of listing or within 30 days of having undergone a lung transplant at one of the enrolling centers.

The study design will generally follow the SOC practices at each center to minimize additional research related visits. Participants will follow the SOC transplant protocols at each site. Every attempt will be made by the site to collect study data and research specimens from participants at the time of SOC visits. Participation in this study will include scheduled data extraction or data transfers at specified time intervals, serial prospective blood collection (including plasma, serum), recipient DNA sample collection (with donor DNA sample collection optional), and PRO measures.

Первичные конечные точки

  • Number of participants enrolled and critical variable completeness [Срок оценки: 3 years]
  • Number of PROs collected per patient [Срок оценки: 3 years]
  • Number of specimens per participant collected [Срок оценки: 3 years]

Критерии участия

Критерии включения

  • Able to understand and provide informed consent
  • ≥ 18 years of age at the time of written informed consent
  • Anticipated listing or listed for a single or bilateral cadaveric donor lung transplant or having received a lung transplant within 30 days
  • Participants undergoing repeat lung transplantation or multi-organ transplantation are eligible if they meet the inclusion/exclusion criteria.

Критерии исключения

  • Unwillingness of a participant or legally authorized representative (LAR) to give written informed consent or comply with study protocol
  • Pregnancy or plans to become pregnant
  • Past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 18 центров
  • University of California Los Angeles — Los Angeles
  • University of California at San Francisco — San Francisco
  • Stanford University Medical Center — Stanford
  • University of Miami — Miami
  • Johns Hopkins University — Baltimore
  • Brigham and Womens Hospital — Boston
  • University of Michigan — Ann Arbor
  • University of Minnesota — Minneapolis
  • … и ещё 10 центров
Канада · 1 центр
  • University Health Network — Toronto

Идентификаторы

NCT: NCT06399302 · Pro00114566 · U24HL163122 · PROMISE Study

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗