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NCT07305090Recruiting

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

Source: ClinicalTrials.gov · Last updated 9 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
90 (estimated)
First submitted
24 Nov 2025
Start date
15 Oct 2025
Primary completion date
15 Oct 2027
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT number
NCT07305090

What you commit to

  • Study type: Observational
  • Planned participants: 90
  • From 15 Oct 2025 to the primary completion date, 15 Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • None

Who the study is looking for

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

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Coordinator of this site? Confirm its status
BolognaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.