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

Hematologic Neoplasms Clinical Trial

— SCTMICROBIOM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04691284
• Other study ID #: PROBIO - SK - 006
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: National Cancer Institute, Slovakia
• Contact: Barbora Kašperová, MD
• Phone: +421-2-59378272
• Email: barbora.kasperova[@]nou.sk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Slovakia	National Cancer Institute	Bratislava

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Institute, Slovakia	Slovak Academy of Sciences

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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