Development of a Multi-biomarker Panel for Prognostic Stratification and Treatment Response Prediction in Acute Graft Versus Host Disease of the Gut (GUT-PREDICTION)
January 8, 2026 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
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
Study Type
Observational
Enrollment (Estimated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with hematological diseases treated with allogeneic hematopoietic cell transplantation
|
The specific activities planned for the study will be:
|
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.
Time Frame: Between the infusion of the transplant and the following 120 days
|
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
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)
|
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
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.