An observational study in GVHD - Graft-Versus-Host Disease, Infections After HSCT and Transplant Associated Microangiopathy TAM, sponsored by University of Turin, Italy. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by University of Turin, Italy · Observational
Allogeneic hematopoietic stem cell transplantation (HSCT) is a life-saving treatment for people with severe blood-related diseases. However, it comes with serious risks, including a condition called graft-versus-host disease (GVHD), where the transplanted cells attack the patient's body. GVHD can occur in about 50% of patients acutely and 35% in a chronic form, potentially affecting organs like the skin, liver, and gastrointestinal system. Currently, doctors diagnose GVHD based on symptoms, as there are no easy tests available.
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.
23 studies on the registry are indexed under Hepatic Veno-Occlusive Disease; 3 are open to participants now.
Browse Hepatic Veno-Occlusive Disease studies →University of Turin, Italy is the lead sponsor of 206 studies on the registry; 34 are open to participants now.
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Patients will be enrolled at the Unità di Ematologia e Trapianto di Midollo Osseo e Oncoematologia of the San Raffaele Hospital in Milan and at the SS Trapianto allogenico e terapie cellulari, SC Ematologia U of the Città della Salute e della Scienza Hospital in Turin.
Exclusion Criteria:
This group gathers all the patients that eventually develop GVHD
Diagnostic Test: Sample collation for cfDNA methylation analysis · Diagnostic Test: Sample collection for EV phenotype analysis
This group gathers all the patients that will not develop post-HSCT complications and show no signs of relapse.
Diagnostic Test: Sample collation for cfDNA methylation analysis · Diagnostic Test: Sample collection for EV phenotype analysis
This group gathers all the patients that develop post-HSCT infections
Diagnostic Test: Sample collation for cfDNA methylation analysis · Diagnostic Test: Sample collection for EV phenotype analysis
This group gathers all the patients that relapse after HSCT
Diagnostic Test: Sample collation for cfDNA methylation analysis · Diagnostic Test: Sample collection for EV phenotype analysis
This goup gathers patients presenting with transplant associated microangiopathy or sinusoidal obstruction.
Sample collation for cfDNA methylation analysis
Analysis of the EV phenotype to evaluate their potential value as markers for GVHD, relapse and engraftment.
Epigenetic profiling of cfDNA in patients developing GVHD
Analysis of cfDNA methylation patterns in GVHD patients vs controls to define potential marker regions to be translationally utilized for early detections of the disease.
Time frame: From enrollment to the end of post-HSCT follow-up of 12 months
Epigenetic profiling of cfDNA in patients developing post-HSCT infections
Analysis of cfDNA methylation patterns in patients developing post-HSCT transplantation infections vs controls to define potential marker regions to be translationally utilized for early detections of the condition.
Time frame: From enrollment to the end of post-HSCT follow-up of 12 months
Epigenetic profiling of cfDNA in patients with engraftment failure
Analysis of cfDNA methylation patterns in patients with engraftment failure vs controls.
Time frame: From enrollment to the end of post-HSCT follow-up of 12 months
Epigenetic profiling of cfDNA in relapsing patients
Description: Analysis of cfDNA methylation patterns in relapsing patients vs controls.
Time frame: From enrollment to the end of post-HSCT follow-up of 12 months
Epigenetic profiling of cfDNA in patients developing transplant associated microangiopathy or sinusoidal obstruction
Time frame: From enrollment to the end of post-HSCT follow-up of 12 months
Evaluation of EV phenotype
Evaluation of circulating vesicle phenotype in as potential biomarker for GVHD, engraftment and relapse.
Time frame: From enrollment to the end of post-HSCT follow-up of 12 months
Plan to share: Undecided
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University of Turin, Italy