CLAD fenotypespesifikke risikofaktorer og mekanismer
En prospektiv multisenter observasjonskohortstudie for å definere risikofaktorer, mekanismer og manifestasjoner av kroniske lunge allograft dysfunksjon (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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
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Ontario
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Toronto, Ontario, Canada, M5G 2N2
- University of Toronto
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-
-
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California
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Los Angeles, California, Forente stater, 90095
- University of California, Los Angeles
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Maryland
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Baltimore, Maryland, Forente stater, 21205
- Johns Hopkins University
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North Carolina
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Durham, North Carolina, Forente stater, 27710
- Duke University
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Ohio
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Adult Lung Transplant Recipients
Adult lung transplant recipients undergoing lung transplant at each of the participating centers. |
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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)
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: John Belperio, MD, University of California, Los Angeles
- Hovedetterforsker: Scott M Palmer, MD, MHS, Duke University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Antatt)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Organisering av lungebetennelse
- Sykdommer i immunsystemet
- Sykdommer i luftveiene
- Lungesykdommer
- Bronkiale sykdommer
- Lungesykdommer, obstruktiv
- Bronchiolitis Obliterans
- Bronkiolitt
- Bronkitt
- Graft vs vertssykdom
- Bronchiolitis Obliterans syndrom
- Undersøkelsesteknikker
- Terapeutikk
- Prøvehåndtering
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Punkteringer
- Kirurgiske prosedyrer, operativ
- Minimalt invasive kirurgiske inngrep
- Diagnostiske teknikker, kirurgisk
- Endoskopi
- Diagnostiske teknikker, luftveissystem
- Thorax kirurgiske inngrep
- Lungekirurgiske prosedyrer
- Phlebotomy
- Blodprøveinnsamling
- Bronkoskopi
Andre studie-ID-numre
- DAIT CTOT-20
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