Cell Free DNA Profiling As a Tool to Monitor Clinically-Relevant Events in Allogeneic Hematopoietic Stem Cell Transplantation
NCT ID: NCT06715046
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2024-01-31
2026-12-31
Brief Summary
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Infections can also be a problem after HSCT, as dormant viruses may reactivate. These infections are monitored using specialized tests. Additionally, doctors use advanced methods, like analyzing minimal residual disease (MRD) and chimerism, to check for the risk of the original disease coming back. MRD is tracked by looking for specific genetic markers of the disease in the patient's blood or bone marrow.
Another emerging tool involves analyzing cell-free DNA (cfDNA)-tiny fragments of DNA found in bodily fluids that come from dying cells. This technique, called liquid biopsy, has been revolutionary in areas like cancer detection, pregnancy testing, and organ transplants. For example, in organ transplants, cfDNA can indicate early signs of rejection, helping reduce the need for invasive biopsies.
In HSCT, the use of cfDNA to monitor complications like GVHD or relapse has not been fully explored. This pilot study aims to investigate whether analyzing cfDNA using a technique called epigenomic profiling can help detect acute GVHD, as well as other post-transplant issues like infections, disease relapse, and chronic GVHD. The goal is to compare cfDNA analysis to current testing methods to see if it offers better or earlier detection of complications.
This research could pave the way for improved, less invasive monitoring of HSCT patients, potentially leading to better outcomes and fewer complications.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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GVHD patients
This group gathers all the patients that eventually develop GVHD
Sample collation for cfDNA methylation analysis
Sample collation for cfDNA methylation analysis
Sample collection for EV phenotype analysis
Analysis of the EV phenotype to evaluate their potential value as markers for GVHD, relapse and engraftment.
Control patients
This group gathers all the patients that will not develop post-HSCT complications and show no signs of relapse.
Sample collation for cfDNA methylation analysis
Sample collation for cfDNA methylation analysis
Sample collection for EV phenotype analysis
Analysis of the EV phenotype to evaluate their potential value as markers for GVHD, relapse and engraftment.
Infection patients
This group gathers all the patients that develop post-HSCT infections
Sample collation for cfDNA methylation analysis
Sample collation for cfDNA methylation analysis
Sample collection for EV phenotype analysis
Analysis of the EV phenotype to evaluate their potential value as markers for GVHD, relapse and engraftment.
Relapse patients
This group gathers all the patients that relapse after HSCT
Sample collation for cfDNA methylation analysis
Sample collation for cfDNA methylation analysis
Sample collection for EV phenotype analysis
Analysis of the EV phenotype to evaluate their potential value as markers for GVHD, relapse and engraftment.
TAD/SOS patients
This goup gathers patients presenting with transplant associated microangiopathy or sinusoidal obstruction.
No interventions assigned to this group
Interventions
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Sample collation for cfDNA methylation analysis
Sample collation for cfDNA methylation analysis
Sample collection for EV phenotype analysis
Analysis of the EV phenotype to evaluate their potential value as markers for GVHD, relapse and engraftment.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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IRCCS San Raffaele
OTHER
University of Turin, Italy
OTHER
Responsible Party
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Silvia Deaglio
Professor of Medical Genetics
Locations
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Unità di Ematologia e Trapianto di Midollo Osseo e Oncoematologia of the San Raffaele Hospital in Milan
Milan, Milan, Italy
SS Trapianto allogenico e terapie cellulari, SC Ematologia U of the Città della Salute e della Scienza Hospital
Turin, Turin, Italy
Countries
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Central Contacts
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References
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Wang X, He B. Insight into endothelial cell-derived extracellular vesicles in cardiovascular disease: Molecular mechanisms and clinical implications. Pharmacol Res. 2024 Sep;207:107309. doi: 10.1016/j.phrs.2024.107309. Epub 2024 Jul 14.
Jodele S, Dandoy CE, Sabulski A, Koo J, Lane A, Myers KC, Wallace G, Chima RS, Teusink-Cross A, Hirsch R, Ryan TD, Benoit S, Davies SM. Transplantation-Associated Thrombotic Microangiopathy Risk Stratification: Is There a Window of Opportunity to Improve Outcomes? Transplant Cell Ther. 2022 Jul;28(7):392.e1-392.e9. doi: 10.1016/j.jtct.2022.04.019. Epub 2022 Apr 29.
Avni B, Neiman D, Shaked E, Gal-Rosenberg O, Grisariu S, Kuzli M, Avni I, Fracchia A, Stepensky P, Zuckerman T, Lev-Sagie A, Fox-Fisher I, Piyanzin S, Moss J, Salpeter SJ, Glaser B, Shemer R, Dor Y. Chronic graft-versus-host disease detected by tissue-specific cell-free DNA methylation biomarkers. J Clin Invest. 2024 Jan 16;134(2):e163541. doi: 10.1172/JCI163541.
Oellerich M, Budde K, Osmanodja B, Bornemann-Kolatzki K, Beck J, Schutz E, Walson PD. Donor-derived cell-free DNA as a diagnostic tool in transplantation. Front Genet. 2022 Oct 21;13:1031894. doi: 10.3389/fgene.2022.1031894. eCollection 2022.
Cheng AP, Cheng MP, Loy CJ, Lenz JS, Chen K, Smalling S, Burnham P, Timblin KM, Orejas JL, Silverman E, Polak P, Marty FM, Ritz J, De Vlaminck I. Cell-free DNA profiling informs all major complications of hematopoietic cell transplantation. Proc Natl Acad Sci U S A. 2022 Jan 25;119(4):e2113476118. doi: 10.1073/pnas.2113476118.
Other Identifiers
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P2022ZRF5H
Identifier Type: -
Identifier Source: org_study_id