Longitudinal Study of Cell Free DNA in Lung Transplant (LoSt)
31. oktober 2022 opdateret af: University of Colorado, Denver
A Longitudinal Study of Donor-Derived Cell Free DNA in Lung Transplant
Lung transplant is a viable treatment strategy for many with end-stage lung diseases.
Despite advances in both the surgical and medical management, lung transplant recipients experience episodes of allograft insult and injury that lead to dysfunction and ultimately contribute to graft failure.
The primary noninvasive tool for monitoring the lung allograft, pulmonary function testing, is neither sensitive nor specific for lung allograft injury which makes the management of lung transplant recipients particularly challenging.
A decline in pulmonary function tests prompts invasive procedures such as bronchoscopy with transbronchial lung biopsy to diagnose the cause of allograft injury, although this, too, is not 100% sensitive, and oftentimes patients are treated empirically for rejection when no other etiology for lung function decline is identified.
Empiric treatment prompted by extrapulmonary drivers of decline in lung function may result in inappropriate exposure to risks of augmented immunosuppression.
The purpose of this study is to determine to what extent monitoring of donor-derived cell free DNA in lung transplant recipients can be used as a marker of lung injury and stability.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
24
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- University of Colorado, Denver
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 99 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Adult patients with end stage lung disease who are placed on the lung transplant waitlist for consideration of a bilateral transplant at the University of Colorado lung transplant program will be recruited for participation in the study.
Beskrivelse
Inclusion Criteria:
- ≥ 18 years old
- Actively listed or have recently had a double lung transplant
- Participant is willing and able to provide informed consent
Exclusion Criteria:
- Prior organ transplantation
- Transplantation performed in the setting of hospitalization for acute illness or decompensation
- Unable or unwilling to consent for enrolment
- Single lung transplant recipient
- Consideration for multi-organ transplantation
- Pregnant women
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Consented adult lung transplant recipients
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Relationship
Tidsramme: 12 Months
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Determine the relationship between donor derived cell free DNA and lung allograft function during the first year after lung transplant.
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12 Months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Quantitative Assessments
Tidsramme: 12 Months
|
Quantitative assessments of dd-cfDNA obtained at pre-specified timepoints post-transplant compared to clinical events (PGD scores, detection of allograft dysfunction, rejection, or infection).
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12 Months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Alice L Gray, MD, University of Colorado, Denver
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Glanville AR, Aboyoun CL, Havryk A, Plit M, Rainer S, Malouf MA. Severity of lymphocytic bronchiolitis predicts long-term outcome after lung transplantation. Am J Respir Crit Care Med. 2008 May 1;177(9):1033-40. doi: 10.1164/rccm.200706-951OC. Epub 2008 Feb 8.
- Levine DJ, Glanville AR, Aboyoun C, Belperio J, Benden C, Berry GJ, Hachem R, Hayes D Jr, Neil D, Reinsmoen NL, Snyder LD, Sweet S, Tyan D, Verleden G, Westall G, Yusen RD, Zamora M, Zeevi A. Antibody-mediated rejection of the lung: A consensus report of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2016 Apr;35(4):397-406. doi: 10.1016/j.healun.2016.01.1223. Epub 2016 Feb 10.
- Khalifah AP, Hachem RR, Chakinala MM, Yusen RD, Aloush A, Patterson GA, Mohanakumar T, Trulock EP, Walter MJ. Minimal acute rejection after lung transplantation: a risk for bronchiolitis obliterans syndrome. Am J Transplant. 2005 Aug;5(8):2022-30. doi: 10.1111/j.1600-6143.2005.00953.x.
- Rademacher J, Suhling H, Greer M, Haverich A, Welte T, Warnecke G, Gottlieb J. Safety and efficacy of outpatient bronchoscopy in lung transplant recipients - a single centre analysis of 3,197 procedures. Transplant Res. 2014 May 27;3:11. doi: 10.1186/2047-1440-3-11. eCollection 2014.
- Chambers DC, Cherikh WS, Goldfarb SB, Hayes D Jr, Kucheryavaya AY, Toll AE, Khush KK, Levvey BJ, Meiser B, Rossano JW, Stehlik J; International Society for Heart and Lung Transplantation. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: Thirty-fifth adult lung and heart-lung transplant report-2018; Focus theme: Multiorgan Transplantation. J Heart Lung Transplant. 2018 Oct;37(10):1169-1183. doi: 10.1016/j.healun.2018.07.020. Epub 2018 Aug 11. No abstract available.
- Hopkins PM, Aboyoun CL, Chhajed PN, Malouf MA, Plit ML, Rainer SP, Glanville AR. Association of minimal rejection in lung transplant recipients with obliterative bronchiolitis. Am J Respir Crit Care Med. 2004 Nov 1;170(9):1022-6. doi: 10.1164/rccm.200302-165OC. Epub 2004 Aug 5.
- Morrell MR, Pilewski JM, Gries CJ, Pipeling MR, Crespo MM, Ensor CR, Yousem SA, D'Cunha J, Shigemura N, Bermudez CA, McDyer JF, Zeevi A. De novo donor-specific HLA antibodies are associated with early and high-grade bronchiolitis obliterans syndrome and death after lung transplantation. J Heart Lung Transplant. 2014 Dec;33(12):1288-94. doi: 10.1016/j.healun.2014.07.018. Epub 2014 Aug 23.
- Kulkarni HS, Bemiss BC, Hachem RR. Antibody-mediated Rejection in Lung Transplantation. Curr Transplant Rep. 2015 Dec;2(4):316-323. doi: 10.1007/s40472-015-0074-5. Epub 2015 Sep 30.
- Verleden GM, Glanville AR, Lease ED, Fisher AJ, Calabrese F, Corris PA, Ensor CR, Gottlieb J, Hachem RR, Lama V, Martinu T, Neil DAH, Singer LG, Snell G, Vos R. Chronic lung allograft dysfunction: Definition, diagnostic criteria, and approaches to treatment-A consensus report from the Pulmonary Council of the ISHLT. J Heart Lung Transplant. 2019 May;38(5):493-503. doi: 10.1016/j.healun.2019.03.009. Epub 2019 Apr 3. No abstract available.
- Glanville AR, Verleden GM, Todd JL, Benden C, Calabrese F, Gottlieb J, Hachem RR, Levine D, Meloni F, Palmer SM, Roman A, Sato M, Singer LG, Tokman S, Verleden SE, von der Thusen J, Vos R, Snell G. Chronic lung allograft dysfunction: Definition and update of restrictive allograft syndrome-A consensus report from the Pulmonary Council of the ISHLT. J Heart Lung Transplant. 2019 May;38(5):483-492. doi: 10.1016/j.healun.2019.03.008. Epub 2019 Apr 3. No abstract available.
- Glanville AR. Bronchoscopic monitoring after lung transplantation. Semin Respir Crit Care Med. 2010 Apr;31(2):208-21. doi: 10.1055/s-0030-1249117. Epub 2010 Mar 30.
- Safavi S, Robinson DR, Soresi S, Carby M, Smith JD. De novo donor HLA-specific antibodies predict development of bronchiolitis obliterans syndrome after lung transplantation. J Heart Lung Transplant. 2014 Dec;33(12):1273-81. doi: 10.1016/j.healun.2014.07.012. Epub 2014 Jul 21.
- Snyder LD, Wang Z, Chen DF, Reinsmoen NL, Finlen-Copeland CA, Davis WA, Zaas DW, Palmer SM. Implications for human leukocyte antigen antibodies after lung transplantation: a 10-year experience in 441 patients. Chest. 2013 Jul;144(1):226-233. doi: 10.1378/chest.12-0587.
- Bharat A, Saini D, Steward N, Hachem R, Trulock EP, Patterson GA, Meyers BF, Mohanakumar T. Antibodies to self-antigens predispose to primary lung allograft dysfunction and chronic rejection. Ann Thorac Surg. 2010 Oct;90(4):1094-101. doi: 10.1016/j.athoracsur.2010.06.009.
- Akbarpour M, Wu Q, Liu X, Sun H, Lecuona E, Tomic R, Bhorade S, Mohanakumar T, Bharat A. Clinical relevance of lung-restricted antibodies in lung transplantation. Hum Immunol. 2019 Aug;80(8):595-601. doi: 10.1016/j.humimm.2019.04.016. Epub 2019 May 8.
- Emtiazjoo AM, Wilkes DS. Humoral immunity and the development of obliterative bronchiolitis after lung transplantation: is there a link? Am J Respir Cell Mol Biol. 2013 Feb;48(2):145-9. doi: 10.1165/rcmb.2012-0349RT. Epub 2012 Oct 18.
- Weigt SS, Wang X, Palchevskiy V, Gregson AL, Patel N, DerHovanessian A, Shino MY, Sayah DM, Birjandi S, Lynch JP 3rd, Saggar R, Ardehali A, Ross DJ, Palmer SM, Elashoff D, Belperio JA. Gene Expression Profiling of Bronchoalveolar Lavage Cells Preceding a Clinical Diagnosis of Chronic Lung Allograft Dysfunction. PLoS One. 2017 Jan 19;12(1):e0169894. doi: 10.1371/journal.pone.0169894. eCollection 2017.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
19. marts 2020
Primær færdiggørelse (Faktiske)
22. november 2021
Studieafslutning (Faktiske)
22. november 2021
Datoer for studieregistrering
Først indsendt
15. januar 2020
Først indsendt, der opfyldte QC-kriterier
15. januar 2020
Først opslået (Faktiske)
21. januar 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. november 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. oktober 2022
Sidst verificeret
1. oktober 2022
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 19-2946
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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