Clinical trial NCT04691284: Microbiome in Cancer Patients With High Dose Chemotherapy With Stem Cell Transplantation
Official title: Microbiome in Cancer Patients Undergoing High Dose Chemotherapy With Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematologic Neoplasms
Keywords: Cancer
microbiome
high dose chemotherapy
stem cell transplantation
CAR-T cell
Lead sponsor: National Cancer Institute, Slovakia
Sponsor class: OTHER_GOV
Collaborators: name: Slovak Academy of Sciences
First posted: 2020-12-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: Currently, available findings coming mainly from allo-HSCT (hhematopoietic cell transplantation) studies, link particular changes in microbiota with overall survival and post-transplant disorders, especially GvHD. According to limited data, further evaluation of associations between the alterations in microbiome composition and toxicities. Detail investigation of both the microbiome and host immune system may help to find microbiome markers useful for very early identification of patients at risk for major transplant-related complications. This might bring the possibility to modulate the gut microbiota in patient´s specific manner to achieve optimal therapeutic outcome and follow-up, while avoiding severe post-transplant complications.

This is prospective, single center, non-randomized, hypothesis generating study. Patients will be asked to provide a sample of blood, urine and stool. This blood will be used for plasma and serum banking for further analysis, including micro RNA (miR) and chemokine detection. Stool will be used for microbiome studies - isolation of total DNA/RNA and 16S (RNA component of the small subunit of a prokaryotic ribosome) rRNA (ribosomal ribonucleic acid) gene sequencing for bacterial taxonomic classification. Furthermore, metagenomic sequencing and subsequent taxonomic and functional classification of microbial genes will be used including characterization of potentially clinically relevant features of the microbiome such as antibiotic resistance and microbial virulence factors.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- patients not-matching inclusion criteria

Primary outcomes:
measure: 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
timeFrame: 100 days
Secondary outcomes:
measure: 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
timeFrame: 100 days
measure: To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients reported outcomes.
timeFrame: 100 days
measure: To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients nutrition status
timeFrame: 100 days
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: National Cancer Institute
Study officials:
affiliation: National Cancer Institute, Slovakia
name: Luboš Drgoňa, Assoc. Prof.
role: STUDY_CHAIR
affiliation: National Cancer Institute, Slovakia
name: Michal Mego, prof.
role: STUDY_CHAIR
References: