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

NCT07305090 | Recruiting

• 2 other identifiers: GUT-PREDICTIONRC-2025-2794670
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Cancer

Keywords

GvHD; aGvHD; GI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (1)

Patients with hematological diseases treated with allogeneic hematopoietic cell transplantation

Other: Adult and pediatric patients with hematological diseases treated with allogeneic hematopoietic cell transplantation

Interventions

Adult and pediatric patients with hematological diseases treated with allogeneic hematopoietic cell transplantation OTHER

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.

Patients with hematological diseases treated with allogeneic hematopoietic cell transplantation

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, saliva, stool, urine, bowel biopsies

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Giovanni Barbara, MD

CONTACT

+390512144103; giovanni.barbara@unibo.it

Maria Raffaella Barbaro, Biologist

CONTACT

+390512144114; maria.barbaro2@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 26, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)