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

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Cancer
• Intervention / Treatment: Other: Adult and pediatric patients with hematological diseases treated with allogeneic hematopoietic cell transplantation

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Giovanni Barbara, MD; Phone Number: +390512144103; Email: giovanni.barbara@unibo.it
• Study Contact Backup: Name: Maria Raffaella Barbaro, Biologist; Phone Number: +390512144114; Email: maria.barbaro2@unibo.it

Study Locations

• Italy
  • Bologna
    • Bologna, Bologna, Italy, 40138
      • Recruiting
      • IRCCS Azienda Ospedaliero-Universitaria di Bologna
      • Contact: Giovanni Barbara, MD; Phone Number: 0512144103; Email: giovanni.barbara@unibo.it
      • Contact: Maria Raffaella Barbaro, Biologist; Phone Number: 0512144114; Email: maria.barbaro2@unibo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will be constituted through the consecutive enrollment of adult and pediatric patients with hematological diseases treated with allogeneic hematopoietic cell transplantation.

Description

Inclusion Criteria:

• Patients aged ≥ 12 years
• Indication for allogeneic HSCT
• Obtaining informed consent

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with hematological diseases treated with allogeneic hematopoietic cell transplantation

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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Estimated): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: GI; GvHD; aGvHD
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: GUT-PREDICTION; RC-2025-2794670 (Other Grant/Funding Number: Ministero della Salute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No