Graft Versus Host Disease (GvHD) Clinical Trials

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Development of a Multi-biomarker Panel for Prognostic Stratification and Treatment Response Prediction in Acute Graft Versus Host Disease of the Gut

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• Patients aged ≥ 12 years

• Indication for allogeneic HSCT

• Obtaining informed consent

Locations
Other Locations
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
RECRUITING
Bologna
Contact Information
Primary
Giovanni Barbara, MD
giovanni.barbara@unibo.it
+390512144103
Backup
Maria Raffaella Barbaro, Biologist
maria.barbaro2@unibo.it
+390512144114
Time Frame
Start Date: 2025-10-15
Estimated Completion Date: 2028-02-01
Participants
Target number of participants: 90
Treatments
Patients with hematological diseases treated with allogeneic hematopoietic cell transplantation
Sponsors
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna

This content was sourced from clinicaltrials.gov