Hematologic NeoplasmsSCTMICROBIOMNCT04691284
Microbiome in Cancer Patients With High Dose Chemotherapy With Stem Cell Transplantation
A study testing Blood, urine and stool sampling in people with Hematologic Neoplasms, run by National Cancer Institute, Slovakia at 1 site in Slovakia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Neoplasms
- What is being tested?
- Blood, urine and stool sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Mar 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients not-matching inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovakia1 site, 1 recruiting
- Recruiting
National Cancer Institute
Bratislava, Slovakia, 83310
Daniela Svetlovska, +421259378 ext. 592, daniela.svetlovska@nou.sk
Barbora Kašperova, MD, +421259378 ext. 272, barbora.kasperova@nou.sk
About this study
Official title: Microbiome in Cancer Patients Undergoing 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.
Read the detailed description
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.
- Conditions
- Hematologic Neoplasms
- Being tested
- Blood, urine and stool sampling
- Keywords
- Cancer, microbiome, high dose chemotherapy, stem cell transplantation, CAR-T cell
- Medical subject headings
- Hematologic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood, urine and stool samplingOther
Sampling of blood and urine for miR and chemokine detection. Sampling of stool for for microbiome studies.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood, urine and stool sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
To assess microbial changes with toxicity of therapy
Measured: 100 days
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
Measured: 100 days
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.
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Mar 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Slovakia
- Sponsor type
- Other government
- Collaborators
- Slovak Academy of Sciences
- Responsible party
- Sponsor
- Investigators
- Luboš Drgoňa, Assoc. Prof., Study chair, National Cancer Institute, SlovakiaMichal Mego, prof., Study chair, National Cancer Institute, Slovakia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691284
- Sponsor's protocol ID
- PROBIO - SK - 006
- Acronym
- SCTMICROBIOM
- Status last verified
- May 2025
- First submitted
- 19 Dec 2020
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome in Cancer Patients Undergoing High Dose Chemotherapy With Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04691284
- Acronym / sponsor ID
- SCTMICROBIOM / PROBIO - SK - 006
- Conditions
- Hematologic Neoplasms
- Keywords
- Cancer, microbiome, high dose chemotherapy, stem cell transplantation, CAR-T cell
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Cancer Institute, SlovakiaOther government
- Collaborators
- Slovak Academy of Sciences
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational arm | Experimental | Other: Blood, urine and stool samplingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- patients not-matching inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood, urine and stool samplingSampling of blood and urine for miR and chemokine detection. Sampling of stool for for microbiome studies. | Other | Observational arm |
Primary outcome
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
3 secondary outcomes
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 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 in stool as measured by 16S rRNA gene sequencing with the patients nutrition status
Time frame: 100 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luboš Drgoňa, Assoc. Prof. study chair
National Cancer Institute, Slovakia
Michal Mego, prof. study chair
National Cancer Institute, Slovakia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood, urine and stool sampling in people with Hematologic Neoplasms, run by National Cancer Institute, Slovakia at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbora Kašperová, MD (+421-2-59378272, barbora.kasperova@nou.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.