Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blood Cancer | Liquid Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adult and pediatric patients with hematological diseases treated with allogeneic hematopoietic cell transplantation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with hematological diseases treated with allogeneic hematopoietic cell transplantation
- interventionNames
- Other: Adult and pediatric patients with hematological diseases treated with allogeneic hematopoietic cell transplantation
Primary outcomes (1)
- measure
- 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.
- timeFrame
- Between the infusion of the transplant and the following 120 days
Secondary outcomes (1)
- measure
- Identification of biomarkers for mortality risk stratification and immunological and nutritional profiling in GvHD
- timeFrame
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged ≥ 12 years * Indication for allogeneic HSCT * Obtaining informed consent Exclusion Criteria: * None
References
Publications (0)
Data not yet available