Urinary Bladder CancerNCT06675656
Predictive Role of Microbiome in Patients With Urothelial Carcinoma
An observational study of Urinary Bladder Cancer, run by IRCCS San Raffaele.
Trial summary
This study aims to establish the microbiota composition as a predictive tool for the response to the intravesical immunotherapy with Bacillus Calmette-Guérin (BCG) and 2 different chemotherapies schemes. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Urinary Bladder Cancer
- What is being tested?
- DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Nov 2035
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with diagnosis of NMIBC, both first diagnosis or relapsing NMIBC.
Who may be able to join
- Adults aged ≥ 18 years, all able to signed informed consent form;
- Diagnosis of NMIBC provided by an experience pathology, by using tissue specimens that were staged according to the TNM classification and morphoarchitectural criteria according to the WHO classification.
Who cannot join
- Participants with ongoing urinary tract infection;
- Antibiotic treatment within the last month;
- Immuno-/chemo- therapy within the past 3 months;
- Chronic immunosuppressive therapy;
- Additional major diagnosis known to affect the gut or bladder microbiota;
- Use of probiotics;
- Uncontrolled diabetes;
- Participants with other malignancy or previous history of oncological or autoimmune diseases.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to establish the microbiota composition as a predictive tool for the response to the intravesical immunotherapy with Bacillus Calmette-Guérin (BCG) and 2 different chemotherapies schemes.
In this prospective cohort study patients with low/intermediate/high risk non muscle invasive bladder carcinoma (NMIBC) that undergo BCG/chemo treatment will be enrolled to collect urine stool and blood at different endpoints. Microbiota, short-chain fatty acids and immunophenotype will be quantified to develop a predictive screening platform, which might also integrate traditional urinary cytology and FISH data.
Read the detailed description
The purpose of this research is to understand the possible use of microbial profile from catheterized urine and feces of patients with NMIBC to categorize patients in two groups: those likely to respond positively and those unlikely to respond to the therapy. Goal of this study is to identify the predictive role of the microbiome to therapy response, thus allowing clinicians to deliver the most appropriate treatment based on the microbiome (microbiome-personalized therapy).
- Conditions
- Urinary Bladder Cancer
- Being tested
- DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.Other
DNA extraction from urine, stool and biopsy for microbiome analysis. Isolation of peripheral blood mononuclear cells from peripheral blood for immunophenotypic analysis, and isolation of serum for analysis of cytokines and bacterial metabolites.
| Study group | Role | What they receive |
|---|---|---|
| 1M. Predictive role of microbiome in male with low grade NMIBC undergoing Gem/Dox. | Predictive role of microbiome in male with low grade non-muscle invasive bladder carcinoma undergoing Gem/Dox. Receives: Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood. | |
| 1F. Predictive role of microbiome in female with low grade NMIBC undergoing Gem/Dox. | Predictive role of microbiome in female with low grade non-muscle invasive bladder carcinoma undergoing Gem/Dox. Receives: Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood. | |
| 2M. Predictive role of microbiome in male with intermediate grade NMIBC undergoing MMC. | Predictive role of microbiome in male with intermediate grade non-muscle invasive bladder carcinoma undergoing MMC. Receives: Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood. | |
| 2F. Predictive role of microbiome in female with intermediate grade NMIBC undergoing MMC. | Predictive role of microbiome in female with intermediate grade non-muscle invasive bladder carcinoma undergoing MMC. Receives: Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood. | |
| 3M. Predictive role of microbiome in male with high grade NMIBC undergoing BCG. | Predictive role of microbiome in male with high grade non-muscle invasive bladder carcinoma undergoing BCG. Receives: Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood. | |
| 3F. Predictive role of microbiome in female with high grade NMIBC undergoing BCG. | Predictive role of microbiome in female with high grade non-muscle invasive bladder carcinoma undergoing BCG. Receives: Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the change of microbial profile in high-grade NMIBC patients after BCG administration
Establish the change of urinary and fecal microbiome richness and diversity, and immunophenotype in bladder carcinoma patients after intravesical BCG treatment.
Measured: 2 years
Secondary outcomes (1)
The predictive role of microbiome in BCG responsiveness
Categorize potential candidates for BCG therapy, based on the microbiota pre-therapy.
Measured: 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder CancerStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Alfano, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675656
- Sponsor's protocol ID
- UROBIOTA
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Role of Microbiome in Patients With Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT06675656
- Acronym / sponsor ID
- UROBIOTA
- Conditions
- Urinary Bladder Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2035 (estimated)
- First posted
- 5 Nov 2024 (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.
This study aims to establish the microbiota composition as a predictive tool for the response to the intravesical immunotherapy with Bacillus Calmette-Guérin (BCG) and 2 different chemotherapies schemes.
In this prospective cohort study patients with low/intermediate/high risk non muscle invasive bladder carcinoma (NMIBC) that undergo BCG/chemo treatment will be enrolled to collect urine stool and blood at different endpoints. Microbiota, short-chain fatty acids and immunophenotype will be quantified to develop a predictive screening platform, which might also integrate traditional urinary cytology and FISH data.
Detailed description
The purpose of this research is to understand the possible use of microbial profile from catheterized urine and feces of patients with NMIBC to categorize patients in two groups: those likely to respond positively and those unlikely to respond to the therapy. Goal of this study is to identify the predictive role of the microbiome to therapy response, thus allowing clinicians to deliver the most appropriate treatment based on the microbiome (microbiome-personalized therapy).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1M. Predictive role of microbiome in male with low grade NMIBC undergoing Gem/Dox. | – | Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.Predictive role of microbiome in male with low grade non-muscle invasive bladder carcinoma undergoing Gem/Dox. |
| 1F. Predictive role of microbiome in female with low grade NMIBC undergoing Gem/Dox. | – | Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.Predictive role of microbiome in female with low grade non-muscle invasive bladder carcinoma undergoing Gem/Dox. |
| 2M. Predictive role of microbiome in male with intermediate grade NMIBC undergoing MMC. | – | Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.Predictive role of microbiome in male with intermediate grade non-muscle invasive bladder carcinoma undergoing MMC. |
| 2F. Predictive role of microbiome in female with intermediate grade NMIBC undergoing MMC. | – | Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.Predictive role of microbiome in female with intermediate grade non-muscle invasive bladder carcinoma undergoing MMC. |
| 3M. Predictive role of microbiome in male with high grade NMIBC undergoing BCG. | – | Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.Predictive role of microbiome in male with high grade non-muscle invasive bladder carcinoma undergoing BCG. |
| 3F. Predictive role of microbiome in female with high grade NMIBC undergoing BCG. | – | Other: DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.Predictive role of microbiome in female with high grade non-muscle invasive bladder carcinoma undergoing BCG. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with diagnosis of NMIBC, both first diagnosis or relapsing NMIBC.
Key inclusion criteria (2 listed)
- Adults aged ≥ 18 years, all able to signed informed consent form;
- Diagnosis of NMIBC provided by an experience pathology, by using tissue specimens that were staged according to the TNM classification and morphoarchitectural criteria according to the WHO classification.
Key exclusion criteria (8 listed)
- Participants with ongoing urinary tract infection;
- Antibiotic treatment within the last month;
- Immuno-/chemo- therapy within the past 3 months;
- Chronic immunosuppressive therapy;
- Additional major diagnosis known to affect the gut or bladder microbiota;
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 |
|---|---|---|
| DNA extraction from urine, stool and biopsy. Isolation of serum and PBMC from peripheral blood.DNA extraction from urine, stool and biopsy for microbiome analysis. Isolation of peripheral blood mononuclear cells from peripheral blood for immunophenotypic analysis, and isolation of serum for analysis of cytokines and bacterial metabolites. | Other | 1F. Predictive role of microbiome in female with low grade NMIBC undergoing Gem/Dox., 1M. Predictive role of microbiome in male with low grade NMIBC undergoing Gem/Dox., 2F. Predictive role of microbiome in female with intermediate grade NMIBC undergoing MMC., 2M. Predictive role of microbiome in male with intermediate grade NMIBC undergoing MMC., 3F. Predictive role of microbiome in female with high grade NMIBC undergoing BCG., 3M. Predictive role of microbiome in male with high grade NMIBC undergoing BCG. |
Primary outcome
Establish the change of microbial profile in high-grade NMIBC patients after BCG administration
Time frame: 2 years
Establish the change of urinary and fecal microbiome richness and diversity, and immunophenotype in bladder carcinoma patients after intravesical BCG treatment.
1 secondary outcome
The predictive role of microbiome in BCG responsiveness
Time frame: 11 years
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 5 Nov 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder Cancer, run by IRCCS San Raffaele.
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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Massimo Alfano, PhD (+39-022643 ext. 6351, alfano.massimo@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish the change of microbial profile in high-grade NMIBC patients after BCG administration (time frame: 2 years). 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 5 Nov 2024.