Exploring the role of microbiome in cancer patients undergoing high-dose chemotherapy and stem cell transplantation
Microbiome in Cancer Patients Undergoing High Dose Chemotherapy With Stem Cell Transplantation
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Cancer Institute, Slovakia Government |
| Drugs / interventions | CAR-T, chemotherapy |
| Locations | 1 site (Bratislava, Slovakia) |
| Trial ID | NCT04691284 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who do not meet the inclusion criteria or are not undergoing the specified treatments may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bratislava, Slovakia
- National Cancer Institute — Bratislava, Slovakia, Slovakia (Recruiting)
Study contacts
- Study coordinator: Barbora Kašperová, MD
- Email: barbora.kasperova@nou.sk
- Phone: +421-2-59378272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.