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

NCT ID: NCT07305090

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2028-02-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with hematological diseases treated with allogeneic hematopoietic cell transplantation

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giovanni Barbara, MD

Role: CONTACT

giovanni.barbara@unibo.it

+390512144103

Maria Raffaella Barbaro, Biologist

Role: CONTACT

maria.barbaro2@unibo.it

+390512144114

Facility Contacts

Giovanni Barbara, MD

Role: primary

giovanni.barbara@unibo.it

0512144103

Maria Raffaella Barbaro, Biologist

Role: backup

maria.barbaro2@unibo.it

0512144114

Other Identifiers

RC-2025-2794670

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GUT-PREDICTION

Identifier Type: -

Identifier Source: org_study_id