Actively Recruiting
Development of a Multi-biomarker Panel for Prognostic Stratification and Treatment Response Prediction in Acute Graft Versus Host Disease of the Gut
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2026-01-09
90
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with blood cancer who undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT), a treatment involving donor stem cells to cure malignant blood diseases. This treatment can cause graft-versus-host disease (GvHD), where the donor's immune cells attack the recipient's tissues. The study focuses on acute GvHD affecting the gut, which has high treatment failure and mortality rates. The goal is to find biomarkers that help predict patient prognosis and treatment responses to improve personalized care. Participants will have samples of blood, saliva, stool, and urine collected. During procedures like colonoscopy or esophagogastroduodenoscopy, two biopsies will be taken for molecular analysis. Patients will complete a food diary and an eating habits questionnaire alongside stool sample collection during their therapy visits. Additionally, their gut permeability will be assessed using sugar tests. The study involves monitoring participants from the time of transplant infusion and for 120 days afterward to identify biomarkers related to the risk of developing gastrointestinal GvHD. Nutritional and immunological profiling will also be performed after therapy begins. Researchers will gather detailed clinical and transplant data to create a predictive tool that can support better treatment strategies. Participation lasts through this monitoring period with no specified maximum age limit.
CONDITIONS
Brief Title
Development of a Multi-biomarker Panel for Prognostic Stratification and Treatment Response Prediction in Acute Graft Versus Host Disease of the Gut
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 65 12 years
- Indication for allogeneic HSCT
- Obtaining informed consent
You will not qualify if you...
- None
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From the infusion of the transplant up to 120 days afterward
Participants provide blood, saliva, stool, and urine samples and undergo assessments including biopsies during colonoscopy or esophagogastroduodenoscopy. They also complete food diaries and questionnaires on eating habits during scheduled visits, and in vivo permeability is assessed using sugar tests.
Visits occur at scheduled times during therapy for sample collection and assessments
Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy, 40138
Actively Recruiting
Research Team
G
Giovanni Barbara, MD
M
Maria Raffaella Barbaro, Biologist
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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