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

NCT ID: NCT07305090

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-15

Study Completion Date

2028-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Blood Cancer

Keywords

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GvHD aGvHD GI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with hematological diseases treated with allogeneic hematopoietic cell transplantation

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

Intervention Type 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.

Interventions

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

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giovanni Barbara, MD

Role: CONTACT

Phone: +390512144103

Email: [email protected]

Maria Raffaella Barbaro, Biologist

Role: CONTACT

Phone: +390512144114

Email: [email protected]

Facility Contacts

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Giovanni Barbara, MD

Role: primary

Maria Raffaella Barbaro, Biologist

Role: backup

Other Identifiers

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RC-2025-2794670

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GUT-PREDICTION

Identifier Type: -

Identifier Source: org_study_id