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NCT Number: NCT06715046

Cell Free DNA Profiling As a Tool to Monitor Clinically-Relevant Events in Allogeneic Hematopoietic Stem Cell Transplantation

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.

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Key information

Conditions

GVHD - Graft-Versus-Host Disease Cardiovascular Diseases Digestive System Diseases Graft vs Host Disease HSCT Engraftment Hepatic Veno-Occlusive Disease Immune System Diseases Infections After HSCT Liver Diseases Sinusoidal Obstruction Syndrome (SOS) Transplant Associated Microangiopathy TAM Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Unità di Ematologia e Trapianto di Midollo Osseo e Oncoematologia of the San Raffaele Hospital in Milan, Milan, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient must be affected by an hematological malignancy requiring hematopoietic stem cell transplantation (HSCT).

Exclusion criteria

  • Patients can not be 17 years old or yunger

Treatment and study plan

Sample collation for cfDNA methylation analysis

Diagnostic Test

Sample collation for cfDNA methylation analysis

Sample collection for EV phenotype analysis

Diagnostic Test

Analysis of the EV phenotype to evaluate their potential value as markers for GVHD, relapse and engraftment.

Primary outcomes

  1. Epigenetic profiling of cfDNA in patients developing GVHD

    Time frame: From enrollment to the end of post-HSCT follow-up of 12 months

    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.

Secondary outcomes

  1. Epigenetic profiling of cfDNA in patients developing post-HSCT infections

    Time frame: From enrollment to the end of post-HSCT follow-up of 12 months

    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.

  2. Epigenetic profiling of cfDNA in patients with engraftment failure

    Time frame: From enrollment to the end of post-HSCT follow-up of 12 months

    Analysis of cfDNA methylation patterns in patients with engraftment failure vs controls.

  3. Epigenetic profiling of cfDNA in relapsing patients

    Time frame: From enrollment to the end of post-HSCT follow-up of 12 months

    Description: Analysis of cfDNA methylation patterns in relapsing patients vs controls.

  4. 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

  5. Evaluation of EV phenotype

    Time frame: From enrollment to the end of post-HSCT follow-up of 12 months

    Evaluation of circulating vesicle phenotype in as potential biomarker for GVHD, engraftment and relapse.

Study contacts

Contact information is provided by the study sponsor or research team.

Silvia Deaglio, MD/PhD

CONTACT

[email protected]

+39 0116709535

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Collaborators

  • IRCCS San Raffaele

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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