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NCT Number: NCT04691284

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Institute

Bratislava, Slovakia, 83310

Location status: Recruiting

Location contact

Barbora Kašperova, MD

CONTACT

[email protected]

+421259378 ext. 272

Barbora Kašperová, MD

PRINCIPAL_INVESTIGATOR

Daniela Svetlovska

CONTACT

[email protected]

+421259378 ext. 592

Luboš Drgoňa, Assoc. Prof

PRINCIPAL_INVESTIGATOR

Michal Mego, Prof

PRINCIPAL_INVESTIGATOR

Soňa Čiernikova, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood, urine and stool sampling

Other

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

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

    Time frame: 100 days

    Microbial changes of stool will be assessed before, at time and after hematopoietic cell transplantation and CAR-T cell therapy

Secondary outcomes

  1. 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

    Time frame: 100 days

    To assess microbial changes with toxicity of therapy

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

    Time frame: 100 days

    To correlate microbial changes with the quality of life, spirituality, cognitive functions

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

    Time frame: 100 days

    To correlate microbial changes with the patients nutrition.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbora Kašperová, MD

CONTACT

[email protected]

+421-2-59378272

Sona Ciernikova, PhD

CONTACT

[email protected]

+421-2-59378273

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Slovakia

Other Gov

Collaborators

  • Slovak Academy of Sciences

Registry information

Official study title

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

Acronym: SCTMICROBIOM

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Dec 31, 2020
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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