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Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a life-saving treatment for many malignant hematologic diseases. Its curative potential is due to both high-dose chemotherapy and the graft-versus-host disease (GvHD) process, in which the donor's T cells recognize the recipient's tissue as foreign. However, GvHD is a potentially fatal complication that significantly affects both survival and quality of life. GvHD can be acute or chronic, and one of the main target organs involved in acute GvHD is the intestine, with a high rate of treatment failure and mortality. We expect to identify a set of biomarkers, both clinical and experimental, that will enable the stratification of patients based on prognosis and response to treatment in intestinal GvHD. The ultimate goal of the study is to integrate clinical, transplant, and biomarker data into a robust predictive algorithm. This tool will enable personalized therapeutic approaches based on early biomarkers, improving prognostic accuracy for patient outcomes and optimizing therapeutic strategies.
Age
12 - No limit years
Sex
ALL
Healthy Volunteers
No
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy
Start Date
October 15, 2025
Primary Completion Date
October 15, 2027
Completion Date
February 1, 2028
Last Updated
January 9, 2026
90
ESTIMATED participants
Adult and pediatric patients with hematological diseases treated with allogeneic hematopoietic cell transplantation
OTHER
Lead Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT05873205
NCT07148180
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