An observational study in Blood Cancer, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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.
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's planned enrollment of 90 is below the median of 186 across 326 observational studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.
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The study population will be constituted through the consecutive enrollment of adult and pediatric patients with hematological diseases treated with allogeneic hematopoietic cell transplantation.
Exclusion Criteria:
Other: 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.
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.
Time frame: Between the infusion of the transplant and the following 120 days
Identification of biomarkers for mortality risk stratification and immunological and nutritional profiling in GvHD
Time frame: After the start of therapy. Nutritional aspects will be assessed upon the patient's admission to the ward and at the onset of the event (GVHD)
Plan to share: No
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IRCCS Azienda Ospedaliero-Universitaria di Bologna