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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute, Slovakia

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood, urine and stool sampling

    Other intervention

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Observational armExperimental treatment 1 intervention

Trial outcomes

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

Time frame
100 days

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

To assess microbial changes with toxicity of therapy

Time frame
100 days
2

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

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

Time frame
100 days
3

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

To correlate microbial changes with the patients nutrition.

Time frame
100 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute, Slovakia

Lead sponsor

Slovak Academy of Sciences

Collaborator