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Clinical Trial NCT06715046 for GVHD - Graft-Versus-Host Disease, Infections After HSCT, Transplant Associated Microangiopathy TAM, Sinusoidal Obstruction Syndrome (SOS), HSCT Engraftment is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Cell Free DNA Profiling As a Tool to Monitor Clinically-Relevant Events in Allogeneic Hematopoietic Stem Cell Transplantation 30

Recruiting
Clinical Trial NCT06715046 is an observational study for GVHD - Graft-Versus-Host Disease, Infections After HSCT, Transplant Associated Microangiopathy TAM, Sinusoidal Obstruction Syndrome (SOS), HSCT Engraftment that is recruiting. It started on 31 January 2024 with plans to enroll 30 participants. Led by University of Turin, Italy, it is expected to complete by 31 December 2026. The latest data from ClinicalTrials.gov was last updated on 4 December 2024.
Brief Summary
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 g...Show More
Official Title

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

Conditions
GVHD - Graft-Versus-Host DiseaseInfections After HSCTTransplant Associated Microangiopathy TAMSinusoidal Obstruction Syndrome (SOS)HSCT Engraftment
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • P2022ZRF5H
NCT ID Number
NCT06715046
Start Date (Actual)
2024-01-31
Last Update Posted
2024-12-04
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
30
Study Type
Observational
Status
Recruiting
Keywords
cfDNA
methylation
epigenetic profile
HSCT
liquid biopsy
Arms / Interventions
Participant Group/ArmIntervention/Treatment
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.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
From enrollment to the end of post-HSCT follow-up of 12 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
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.
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.
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
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.
From enrollment to the end of post-HSCT follow-up of 12 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Patient must be affected by an hematological malignancy requiring hematopoietic stem cell transplantation (HSCT).

  • Patients can not be 17 years old or yunger
University of Turin, Italy logoUniversity of Turin, Italy
IRCCS San Raffaele logoIRCCS San Raffaele
Study Responsible Party
Silvia Deaglio, Principal Investigator, Professor of Medical Genetics, University of Turin, Italy
Study Central Contact
Contact: Silvia Deaglio, MD/PhD, +39 0116709535, [email protected]
2 Study Locations in 1 Countries

Milan

Unità di Ematologia e Trapianto di Midollo Osseo e Oncoematologia of the San Raffaele Hospital in Milan, Milan, Milan, 10132, Italy
Recruiting

Turin

SS Trapianto allogenico e terapie cellulari, SC Ematologia U of the Città della Salute e della Scienza Hospital, Turin, Turin, 10126, Italy
Recruiting