CLAD fænotypespecifikke risikofaktorer og mekanismer
Et prospektivt multicenter observationelt kohortestudie til at definere risikofaktorer, mekanismer og manifestationer af kronisk lunge allograft dysfunktion (CLAD) fænotyper (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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2N2
- University of Toronto
-
-
-
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California
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Los Angeles, California, Forenede Stater, 90095
- University of California, Los Angeles
-
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Maryland
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Baltimore, Maryland, Forenede Stater, 21205
- Johns Hopkins University
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke University
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Ohio
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Adult lung transplant recipients undergoing lung transplant at each of the participating centers.
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Adult Lung Transplant Recipients
Adult lung transplant recipients undergoing lung transplant at each of the participating centers. |
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time from transplant to Restrictive Chronic Lung Allograft Dysfunction (RCLAD) or Bronchiolitis Obliterans Syndrome (BOS).
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Longitudinal Quality of life (QOL) trajectory
Tidsramme: 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
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: John Belperio, MD, University of California, Los Angeles
- Ledende efterforsker: Scott M Palmer, MD, MHS, Duke University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Organisering af lungebetændelse
- Sygdomme i immunsystemet
- Luftvejssygdomme
- Lungesygdomme
- Bronchiale sygdomme
- Lungesygdomme, obstruktiv
- Bronchiolitis Obliterans
- Bronchiolitis
- Bronkitis
- Graft vs værtssygdom
- Bronchiolitis Obliterans syndrom
- Undersøgelsesteknikker
- Terapeutik
- Håndtering af eksemplar
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og procedurer
- Diagnose
- Punkteringer
- Kirurgiske procedurer, operative
- Minimalt invasive kirurgiske procedurer
- Diagnostiske teknikker, kirurgisk
- Endoskopi
- Diagnostiske teknikker, åndedrætssystem
- Thorax kirurgiske procedurer
- Pulmonale kirurgiske procedurer
- Phlebotomy
- Blodprøveopsamling
- Bronchoscopy
Andre undersøgelses-id-numre
- DAIT CTOT-20
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