Study to Develop a Biomarker Panel Predicting Outcomes and Treatment Response in Acute Gut Graft Versus Host Disease After Allogeneic Stem Cell Transplantation

What this Trial Is About

Researchers are studying patients with blood cancer who undergo allogeneic hematopoietic stem cell transplantation allo-HSCT, a treatment involving donor stem cells to cure malignant blood diseases. This treatment can cause graft-versus-host disease GvHD, where the donors immune cells attack the recipients tissues. The study focuses on acute GvHD affecting the gut, which has high treatment failure and mortality rates. The goal is to find biomarkers that help predict patient prognosis and treatment responses to improve personalized care. Participants will have samples of blood, saliva, stool, and urine collected. During procedures like colonoscopy or esophagogastroduodenoscopy, two biopsies will be taken for molecular analysis. Patients will complete a food diary and an eating habits questionnaire alongside stool sample collection during their therapy visits. Additionally, their gut permeability will be assessed using sugar tests. The study involves monitoring participants from the time of transplant infusion and for 120 days afterward to identify biomarkers related to the risk of developing gastrointestinal GvHD. Nutritional and immunological profiling will also be performed after therapy begins. Researchers will gather detailed clinical and transplant data to create a predictive tool that can support better treatment strategies. Participation lasts through this monitoring period with no specified maximum age limit.

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