CLAD 표현형 특정 위험 요인 및 메커니즘
만성 폐 동종이식 기능 장애(CLAD) 표현형(CTOT-20)의 위험 요인, 메커니즘 및 징후를 정의하기 위한 전향적 다기관 관찰 코호트 연구
While many patients experience benefits from transplant, complications such as infections and lung rejection may affect long term survival and quality of life. In this study doctors are looking at a complication called Chronic Lung Allograft Dysfunction (CLAD). CLAD is thought to be chronic rejection of the lung by the immune system and is the leading cause of death after lung transplantation.
The purpose of this study is to help doctors determine:
- why some people get CLAD and others do not
- how patients who get CLAD do after CLAD is diagnosed
- how CLAD may affect quality of life
연구 개요
상세 설명
This is an observational, prospective, multicenter study of newly transplanted adult, first lung transplant recipients that will collect longitudinal clinical data, patient reported quality of life (QOL) data, and serial biological samples to determine the risk factors, pathophysiology, and manifestations of restrictive chronic lung allograft dysfunction (RCLAD) and bronchiolitis obliterans syndrome (BOS). Anticipated participant accrual is within three years of study start-up. The total study duration is four years. Participants will be followed a minimum of 1 and a maximum of 4 years.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90095
- University of California, Los Angeles
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Maryland
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Baltimore, Maryland, 미국, 21205
- Johns Hopkins University
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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke University
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Ohio
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Cleveland, Ohio, 미국, 44195
- Cleveland Clinic
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Ontario
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Toronto, Ontario, 캐나다, M5G 2N2
- University of Toronto
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Adult lung transplant recipients undergoing lung transplant at each of the participating centers.
설명
Inclusion Criteria:
Individuals who meet all of the following criteria are eligible for enrollment as study participants:
-
Subject must be able to understand and provide written informed consent and
-Must be ≥18 years of age at the time of written informed consent.
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Anticipated listing for lung transplantation OR within 45 days of having received a single or bilateral cadaveric donor lung transplant.
- Enrollment must occur prior to the start of bronchoscopies eligible for research bronchoalveolar lavage (BAL) sampling.
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Undergoing first lung transplant operation.
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Transplant surgery to be performed or performed at enrolling center.
- Note: Concurrent participation in immune monitoring studies or interventional device trials are permitted.
Exclusion Criteria:
Individuals who meet any of the following criteria are not eligible for enrollment as study participants:
- Multi-organ recipient.
- Prior recipients of any solid organ transplant, including prior lung transplant.
- Prior or concurrent recipient of bone marrow transplant.
- HIV infection.
- Any condition which the investigators feel would make it unlikely for the recipient to complete follow up procedures or complete the study.
- Participation in an investigational drug trial at the time of enrollment visit.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Adult Lung Transplant Recipients
Adult lung transplant recipients undergoing lung transplant at each of the participating centers. |
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time from transplant to Restrictive Chronic Lung Allograft Dysfunction (RCLAD) or Bronchiolitis Obliterans Syndrome (BOS).
기간: 90 days post-transplant until study completion or participant withdrawal (up to 4 years post-transplant)
|
First occurrence of either phenotype. |
90 days post-transplant until study completion or participant withdrawal (up to 4 years post-transplant)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Longitudinal Quality of life (QOL) trajectory
기간: Baseline until study completion or participant withdrawal (up to 4 years post-transplant)
|
As serially assessed by the 36-item Short Form Survey (SF-36) and the St. George's Respiratory Questionnaire (SGRQ) |
Baseline until study completion or participant withdrawal (up to 4 years post-transplant)
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Mechanistic: Chemokine/cytokine Quantification of Type 1 and Type 17 immune profile proteins
기간: Baseline until study completion or participant withdrawal (up to 4 years post-transplant)
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Measured in the Bronchoalveolar lavage (BAL) supernatant.using standard Luminex and ELISA commercial assays |
Baseline until study completion or participant withdrawal (up to 4 years post-transplant)
|
공동 작업자 및 조사자
수사관
- 연구 의자: John Belperio, MD, University of California, Los Angeles
- 수석 연구원: Scott M Palmer, MD, MHS, Duke University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- DAIT CTOT-20
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