Clinical trial Recruiting at 1 site Observational Ages 12 and up

Multi-biomarker panel to predict prognosis and treatment response in intestinal acute graft-versus-host disease

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

Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07305090 · Data updated 2026-11-12

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 typeObservational
Ages12 Years and up
SexAll
Enrollment90 (estimated)
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Bologna, Bologna)
StatusRecruiting
StartedOctober 15, 2025
Main results expectedOctober 15, 2027
Study endsFebruary 1, 2028
Registry record updatedJanuary 9, 2026
Trial IDNCT07305090 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

* None

Where it's running

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Bologna, Bologna, Italy
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.