About this trial
Numerous in vitro and animal studies as well as growing number of clinical studies support the important role of microbiome in carcinogenesis and cancer treatment. Detection of changes in patients´ microbiome following hematopoietic cell transplantation/CAR-T cell therapy and correlations with adverse transplant outcomes, mainly infectious complications, acute and chronic GvHD, disease recurrence etc. could serve as predictive markers of immune recovery and treatment response.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
signed written informed consent
aged 18 years or older
patients planned to be treated by high-dose chemotherapy and hematopoietic cell transplantation or by CAR-T cell therapy in National Cancer Institute, Slovakia
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Blood, urine and stool sampling
Other interventionSampling of blood and urine for miR and chemokine detection. Sampling of stool for for microbiome studies.
Treatment groups
Trial outcomes
Primary outcomes
Microbial changes in stool as measured by 16S rRNA gene sequencing in hematological cancer patients before, at time and after hematopoietic cell transplantation and CAR-T cell therapy
Microbial changes of stool will be assessed before, at time and after hematopoietic cell transplantation and CAR-T cell therapy
Secondary outcomes
To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the post-transplant complications in auto and allogeneic transplant settings (GvHD, diarrhea, infectious complications) and in CAR-T cell therapy
To assess microbial changes with toxicity of therapy
To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients reported outcomes.
To correlate microbial changes with the quality of life, spirituality, cognitive functions
To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients nutrition status
To correlate microbial changes with the patients nutrition.
Sponsors and contacts
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National Cancer Institute, Slovakia
Lead sponsor
Slovak Academy of Sciences
Collaborator