Exploring the role of microbiome in cancer patients undergoing high-dose chemotherapy and stem cell transplantation
Official title: Microbiome in Cancer Patients Undergoing High Dose Chemotherapy With Stem Cell Transplantation
Run by National Cancer Institute, Slovakia · NCT04691284 · Data updated 2026-11-12
This study is trying to see how changes in the gut bacteria of cancer patients receiving high-dose chemotherapy and stem cell transplants might affect their recovery and risk of complications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | National Cancer Institute, Slovakia Government |
| Drugs / interventions | CAR-T, chemotherapy |
| Locations | 1 site (Bratislava, Slovakia) |
| Status | Recruiting |
| Started | March 1, 2021 |
| Main results expected | December 2025 |
| Study ends | December 2026 |
| Registry record updated | May 29, 2025 |
| Trial ID | NCT04691284 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are scheduled to receive high-dose chemotherapy and hematopoietic cell transplantation or CAR-T cell therapy.
✕Probably not a fit
Patients who do not meet the inclusion criteria or are not undergoing the specified treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the changes in the microbiome of cancer patients receiving high-dose chemotherapy and hematopoietic cell transplantation or CAR-T cell therapy. It aims to identify correlations between microbiome alterations and adverse transplant outcomes, such as infections and graft-versus-host disease (GvHD). By analyzing blood, urine, and stool samples, researchers will perform detailed microbiome studies and immune system evaluations to find predictive markers for transplant-related complications. The goal is to potentially modulate the gut microbiota to improve therapeutic outcomes and reduce severe complications.
Why it matters
Potential benefit: If successful, this study could lead to personalized interventions that enhance recovery and reduce complications for cancer patients undergoing intensive treatments.
How similar studies have gone: While there is emerging evidence linking microbiome changes to cancer treatment outcomes, this specific approach is relatively novel and has not been extensively tested in similar studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
National Cancer Institute
Bratislava, Slovakia, Slovakia Recruiting
Study contacts
- Study coordinator: Barbora Kašperová, MD
- Email: barbora.kasperova@nou.sk
- Phone: +421-2-59378272
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.