CLAD fenotypspecifika riskfaktorer och mekanismer
En prospektiv multicenter observationskohortstudie för att definiera riskfaktorer, mekanismer och manifestationer av kronisk lungallograftdysfunktion (CLAD) fenotyper (CTOT-20)
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
California
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Los Angeles, California, Förenta staterna, 90095
- University of California, Los Angeles
-
-
Maryland
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Baltimore, Maryland, Förenta staterna, 21205
- Johns Hopkins University
-
-
North Carolina
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Durham, North Carolina, Förenta staterna, 27710
- Duke University
-
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Ohio
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic
-
-
-
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Ontario
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Toronto, Ontario, Kanada, M5G 2N2
- University of Toronto
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Adult lung transplant recipients undergoing lung transplant at each of the participating centers.
Beskrivning
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.
-
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Adult Lung Transplant Recipients
Adult lung transplant recipients undergoing lung transplant at each of the participating centers. |
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time from transplant to Restrictive Chronic Lung Allograft Dysfunction (RCLAD) or Bronchiolitis Obliterans Syndrome (BOS).
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Longitudinal Quality of life (QOL) trajectory
Tidsram: 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)
|
|
Mechanistic: Chemokine/cytokine Quantification of Type 1 and Type 17 immune profile proteins
Tidsram: Baseline until study completion or participant withdrawal (up to 4 years post-transplant)
|
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)
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: John Belperio, MD, University of California, Los Angeles
- Huvudutredare: Scott M Palmer, MD, MHS, Duke University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Beräknad)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Organisera lunginflammation
- Immunsystemets sjukdomar
- Luftvägssjukdomar
- Lungsjukdomar
- Bronkialsjukdomar
- Lungsjukdomar, obstruktiv
- Bronchiolit Obliterans
- Bronkiolit
- Bronkit
- Graft vs Host Disease
- Bronkiolit Obliterans syndrom
- Undersökningstekniker
- Terapeutik
- Provhantering
- Kliniska laboratorietekniker
- Diagnostiska tekniker och procedurer
- Diagnos
- Punktering
- Kirurgiska ingrepp, operativ
- Minimalt invasiva kirurgiska ingrepp
- Diagnostiska tekniker, kirurgiska
- Endoskopi
- Diagnostiska tekniker, andningssystem
- Thoraxkirurgiska ingrepp
- Lungkirurgiska ingrepp
- Slebotomi
- Blodprovsamling
- Bronkoskopi
Andra studie-ID-nummer
- DAIT CTOT-20
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