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

NCT04691284 | Recruiting

• 1 other identifier: PROBIO - SK - 006
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Neoplasms

Keywords

Cancer; microbiome; high dose chemotherapy; stem cell transplantation; CAR-T cell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  100 days

• To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients reported outcomes.

  100 days

• To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients nutrition status

  100 days

Study Arms (1)

Observational arm

EXPERIMENTAL

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

Interventions

Blood, urine and stool sampling OTHER

Sampling of blood and urine for miR and chemokine detection. Sampling of stool for for microbiome studies.

Observational arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute, Slovakia: lead
• Slovak Academy of Sciences: collaborator

Study Sites (1)

National Cancer Institute

Bratislava, Slovakia, 83310, Slovakia

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Neoplasms

Interventions

Blood Specimen Collection; Urination

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Luboš Drgoňa, Assoc. Prof.

  National Cancer Institute, Slovakia

  STUDY CHAIR

• Michal Mego, prof.

  National Cancer Institute, Slovakia

  STUDY CHAIR

Central Study Contacts

Barbora Kašperová, MD

CONTACT

+421-2-59378272; barbora.kasperova@nou.sk

Sona Ciernikova, PhD

CONTACT

+421-2-59378273; sona.ciernikova@savba.sk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: December 31, 2020
• Study Start: March 1, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)