Study of Microbiome Changes in Cancer Patients Receiving High-Dose Chemotherapy and Stem Cell Transplantation or CAR-T Cell Therapy

What this Trial Is About

Researchers are exploring the important role of the microbiome in cancer development and treatment, particularly in patients undergoing high-dose chemotherapy and stem cell transplantation or CAR-T cell therapy. This study aims to detect changes in patients microbiomes during these treatments and examine their links to complications such as infections, graft-versus-host disease GvHD, and disease recurrence. Understanding these connections could help predict immune recovery and treatment response. Participants will provide samples of blood, urine, and stool. Blood samples will be used for plasma and serum banking to analyze micro RNA and chemokines. Stool samples will undergo microbiome studies including DNARNA isolation, 16S rRNA gene sequencing for bacterial classification, and metagenomic sequencing to identify microbial genes related to antibiotic resistance and virulence factors. This is a prospective, single-center, non-randomized study. During the study, researchers will monitor microbial changes in stool before, during, and after hematopoietic cell transplantation or CAR-T cell therapy over 100 days. They will also assess correlations between stool microbiome changes and post-transplant complications, patient-reported outcomes, and nutritional status. The study involves multiple sample collections and analysis to better understand microbiome markers that might predict transplant-related complications and aid personalized treatment and follow-up.

Microbiome in Cancer Patients With High Dose Chemotherapy With Stem Cell Transplantation