Blood Cancer
Conditions
Keywords
GvHD, aGvHD, GI
Brief 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.
Interventions
OTHERAdult 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.
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged ≥ 12 years * Indication for allogeneic HSCT * Obtaining informed consent
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Identification of biomarkers for mortality risk stratification and immunological and nutritional profiling in GvHD | 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) |
Countries
Italy
Contacts
Primary ContactGiovanni Barbara, MD
Backup ContactMaria Raffaella Barbaro, Biologist
Outcome results
None listed