Microbiome in Cancer Patients With High Dose Chemotherapy With Stem Cell Transplantation (SCTMICROBIOM)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematologic Neoplasms
• Intervention / Treatment: Other: Blood, urine and stool sampling

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barbora Kašperová, MD; Phone Number: +421-2-59378272; Email: barbora.kasperova@nou.sk
• Study Contact Backup: Name: Sona Ciernikova, PhD; Phone Number: +421-2-59378273; Email: sona.ciernikova@savba.sk

Study Locations

• Slovakia
  • Bratislava, Slovakia, 83310
    • Recruiting
    • National Cancer Institute
    • Principal Investigator: Michal Mego, Prof
    • Contact: Daniela Svetlovska; Phone Number: 592 +421259378; Email: daniela.svetlovska@nou.sk
    • Contact: Barbora Kašperova, MD; Phone Number: 272 +421259378; Email: barbora.kasperova@nou.sk
    • Principal Investigator: Luboš Drgoňa, Assoc. Prof
    • Principal Investigator: Soňa Čiernikova, PhD
    • Principal Investigator: Barbora Kašperová, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Observational arm; 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 miR and chemokine detection. Stool will be used for microbiome studies - isolation of total DNA/RNA and 16S rRNA gene sequencing for bacterial taxonomic classification. Furthermore, metagenomic sequencing and subsequent taxonomic and functional classification of microbial genes will be used. Moreover, we might be able to characterized potentially clinically relevant features of the microbiome such as antibiotic resistance and microbial virulence factors.

Other: Blood, urine and stool sampling; Sampling of blood and urine for miR and chemokine detection. Sampling of stool for for microbiome studies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	100 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	100 days
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	100 days
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.	100 days

Collaborators and Investigators

• Sponsor: National Cancer Institute, Slovakia
• Collaborators: Slovak Academy of Sciences
• Investigators: Study Chair: Luboš Drgoňa, Assoc. Prof., National Cancer Institute, Slovakia; Study Chair: Michal Mego, prof., National Cancer Institute, Slovakia

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 19, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; stem cell transplantation; microbiome; CAR-T cell; high dose chemotherapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: PROBIO - SK - 006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No