Microbiome in Cancer Patients Undergoing High Dose Chemotherapy With Stem Cell Transplantation
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Slovakia
National Cancer Institute
RECRUITING
Bratislava
Contact Information
Primary
Barbora Kašperová, MD
barbora.kasperova@nou.sk
+421-2-59378272
Backup
Sona Ciernikova, PhD
sona.ciernikova@savba.sk
+421-2-59378273
Time Frame
Start Date: 2021-03-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Slovak Academy of Sciences
Leads: National Cancer Institute, Slovakia