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NCT Number: NCT07305090

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

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.

Recruiting

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Adult and pediatric patients with hematological diseases treated with allogeneic hematopoietic cell transplantation

Other

The specific activities planned for the study will be:

  • collection of blood, saliva, stool, and urine samples
  • during colonoscopy or esophagogastroduodenoscopy, two biopsies will be taken for molecular biology analysis
  • administration of a food diary together with a questionnaire on eating habits, to be completed by the patient on the days of scheduled visits during the course of therapy, in conjunction with the collection of stool samples.
  • assessment of in vivo permeability using sugar tests.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Barbara, MD

CONTACT

[email protected]

+390512144103

Maria Raffaella Barbaro, Biologist

CONTACT

[email protected]

+390512144114

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: GUT-PREDICTION

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 26, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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