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

Condition(s) studied

Investigational drug(s) / intervention(s)

Adult and pediatric patients with hematological diseases treated with allogeneic hematopoietic cell transplantation: The specific activities planned for the study will be: * collection of blood, saliva, stool, and urine samples * during colonoscopy or esophagogastroduodenoscopy, two biopsies will be taken for molecular biology analysis * administration of a food diary together with a questionnaire on eating habits, to be completed by the patient on the days of scheduled visits during the course of therapy, in conjunction with the collection of stool samples. * assessment of in vivo permeability using sugar tests.

Study 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

Primary outcome measure(s)

• Identify a set of biomarkers capable of stratifying the overall risk of developing grade 2-4 GI GVHD in adult and pediatric patients with hematological diseases undergoing allogeneic hematopoietic cell transplantation. — Between the infusion of the transplant and the following 120 days

Trial sites (1)

More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Italy