Multi-biomarker panel to predict prognosis and treatment response in intestinal acute graft-versus-host disease
Development of a Multi-biomarker Panel for Prognostic Stratification and Treatment Response Prediction in Acute Graft Versus Host Disease of the Gut
IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07305090
This study will test whether a set of clinical and lab biomarkers can predict who will do well or poorly and who will respond to treatment for intestinal acute GvHD after an allogeneic stem cell transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT07305090 on ClinicalTrials.gov |
What this trial studies
This observational study will collect clinical, transplant and experimental biomarker data from patients aged 12 and older treated with allogeneic hematopoietic stem cell transplantation at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The focus is on intestinal acute graft-versus-host disease, with serial measurement of candidate blood and clinical biomarkers and linkage to treatment and outcome data. Researchers will integrate these data to develop and validate a predictive algorithm for prognosis and treatment response. No investigational therapies are given; the goal is to create a tool to guide personalized care.
Who should consider this trial
Good fit: Ideal candidates are patients aged 12 or older who are undergoing allogeneic hematopoietic stem cell transplantation, especially those who develop intestinal acute GvHD.
Not a fit: Patients younger than 12, people not undergoing allo-HSCT, or those without intestinal involvement of GvHD are unlikely to benefit directly from this work.
Why it matters
Potential benefit: If successful, the biomarker panel could enable earlier, personalized treatment decisions that reduce mortality and treatment failure in intestinal aGvHD.
How similar studies have performed: Prior research has identified individual biomarkers (for example ST2 and Reg3α) and multimarker approaches have shown promise, although fully validated predictive algorithms are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged ≥ 12 years * Indication for allogeneic HSCT * Obtaining informed consent Exclusion Criteria: * None
Where this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (RECRUITING)
Study contacts
- Study coordinator: Giovanni Barbara, MD
- Email: giovanni.barbara@unibo.it
- Phone: +390512144103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Blood Cancer, GvHD, aGvHD, GI