MicrobiomeSILENTEMPIRENCT05204199
Role of Microbiome in BCG Responsiveness Prediction
An observational study of Microbiome and Bladder Cancer, run by Cédric Poyet at 5 sites in Switzerland.
Trial summary
Our primary aim is to investigate the use of microbial profile from the bladder and the feces of NMIBC patients as a predicting tool for therapy response prior to BCG administration. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Microbiome, Bladder Cancer
- How many people
- 120 participants
- Where
- 5 sitesSwitzerland
- Study dates
- 22 Feb 2022to 20 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Group A: Patients without a urological or gastrointestinal malignancy undergoing non-oncological bladder surgery or transurethral resection of the prostate (TUR-P) fulfilling the following criteria. At the time of study inclusion, no urological symptoms or relevant urological disease (Unclear Macrohematuria, Cystolithiasis, prostate Cancer ) Group B: Low Risk NMIBC (primary, solitary, Ta / low grad < 3cm, no carcinoma in situ (CIS)). Group C: NMIBC patients, BCG candidates, assessed as intermediate (between the category of low- and high risk) or high risk (T1 or high grade or CIS or multiple, recurrent and large (> 3 cm) Ta/ low grade tumours).
Who may be able to join
- Signed informed consent
- Ability to understand and follow study procedures and understand informed consent
- age 18 - 90 years
Who cannot join
- Antibiotic treatment within the last month
- Immuno-/chemotherapy within the past 6 months
- Immunosuppressive therapy
- Major medical, neoplastic (with the exception of skin cancer), surgical or psychiatric condition requiring ongoing management. Minor, well-controlled conditions, such as medically controlled arterial hypertension or occupational asthma, may be present.
- Additional major diagnosis known to affect the gut or bladder microbiota (e. g. liver cirrhosis, systemic sclerosis, inflammatory bowel disease, inflammatory bowel syndrome, celiac disease, neuropathic bladder)
- Major past intestinal surgery, especially in small intestine or colon. Cholecystectomy, appendectomy, past perianal surgery or past hernia repair may be present.
Show all 9Show fewer
- Major gastrointestinal symptoms (diarrhoea, constipation, abdominal pain, vomiting, unexplained weight loss, rectal bleeding or blood in the stool)
- Bladder augmentation surgery.
- Indwelling urinary catheter
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Switzerland5 sites, 5 recruiting
- Recruiting
Kantonsspital Baden
Baden, Canton of Aargau, 5404
Lukas J. Hefermehl, MD, lukas.hefermehl@ksb.ch
Lukas J. Hefermehl, MD
- Not yet recruiting
Spitalzentrum Biel
Biel/Bienne, Canton of Bern, 2501
Roland Seiler-Blarer, Prof., roland.seiler-blarer@szb-chb.ch
Roland Seiler-Blarer, Prof.
- Recruiting
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007
Daniel Engeler, MD, daniel.engeler@kssg.ch
Daniel Engeler, MD
- Recruiting
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401
Beat Förster, MD, beat.foerster@ksw.ch
Beat Förster, MD
- Recruiting
University Hospital Zürich
Zurich, 8091
Cédric Poyet, MD, 0041 44 255 11 11, cedric.poyet@usz.ch
Uwe Bieri, MD
About this study
Official title: Towards Individualization of Bladder Cancer Therapy: the Role of Microbiome in BCG Responsiveness Prediction
Our primary aim is to investigate the use of microbial profile from the bladder and the feces of NMIBC patients as a predicting tool for therapy response prior to BCG administration.
Our second aim is to collect additional samples (blood, instrumented urine, bladder tissue, feces) to establish a local biobank for future microbiome projects.
Read the detailed description
The microbiome, defined as a characteristic microbial community occupying a reasonably well-defined environment (e.g. gut microbiome), has been increasingly linked with different medical conditions and also with cancer. While there have been numerous investigations into the gut bacterial ecosystem, scientists have started to pay attention to the microbiome of the bladder only recently. Results from newest investigations support the understanding that the bladder possesses its own microbiome and it is not germ-free. Studying the relationship between bladder cancer and bladder and gut microbiome may lead to new insights which can be used to predict tumor behavior and/or response to therapy.
With this project, we aim to investigate the use of microbial fingerprint from the bladder and from the feces of bladder cancer patients in predicting therapy response prior to administration of Bacillus Calmette-Guerin or BCG. BCG causes the body's own immune system to attack the bladder cancer cells. It is applied directly into the bladder to prevent the cancer from growing and from regrowing. However, in around 40% of patients this treatment is not successful, BCG should be avoided, and other therapy strategies should be chosen. Unfortunately, there is no test available yet, which help to select patients who will benefit from the therapy before the therapy is started.
In this project we intend to determine the microbial fingerprint and to analyze if this fingerprint can be used as a selection tool. This tool may enable as us in the future to avoid application of BCG therapy for patient with a high risk of therapy failure and save time to start alternative therapy options and hopefully avoid tumor progression. Our second aim is to collect additional samples (blood, instrumented urine, bladder tissue, feces) to establish a local biobank for future microbiome projects.
- Conditions
- Microbiome, Bladder Cancer
- Keywords
- BCG
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients without a urological or gastrointestinal malignancy undergoing non-oncological bladder surgery or transurethral resection of the prostate (TUR-P) | |
| Group B | Low Risk NMIBC (primary, solitary, Ta / low grad < 3cm, no carcinoma in situ (CIS)) | |
| Group C | NMIBC patients, BCG candidates, assessed as intermediate (between the category of low- and high risk) or high risk (T1 or high grade or CIS or multiple, recurrent and large (> 3 cm) Ta/ low grade tumours). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in microbial Profile
use of microbial profile from the bladder and the feces of NMIBC patients as a potential binary classification system, to substratify BCG-candidates into "anticipated BCG-responder (aBCGr)" and "anticipated BCG-non-responder (aBCGnr)" groups in predicting therapy response prior to BCG administration.
Measured: 1 year
Secondary outcomes (1)
Biobank
collect additional samples (blood, instrumented urine, bladder tissue, feces) to establish a local biobank for future microbiome projects
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start22 Feb 2022
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MicrobiomeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cédric Poyet
- Sponsor type
- University, hospital or other
- Collaborators
- Krebsliga Schweiz
- Responsible party
- Sponsor-investigator, Cédric Poyet, University of Zurich
- Investigators
- Cédric Poyed, MD, Principal investigator, University Hospital Zurich, Departement of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204199
- Sponsor's protocol ID
- 2021-01783
- Acronym
- SILENTEMPIRE
- Status last verified
- Apr 2024
- First submitted
- 29 Dec 2021
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bieri U, Scharl M, Sigg S, Szczerba BM, Morsy Y, Ruschoff JH, Schraml PH, Krauthammer M, Hefermehl LJ, Eberli D, Poyet C. Prospective observational study of the role of the microbiome in BCG responsiveness prediction (SILENT-EMPIRE): a study protocol. BMJ Open. 2022 Apr 18;12(4):e061421. doi: 10.1136/bmjopen-2022-061421.
PubMed 35437256
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Individualization of Bladder Cancer Therapy: the Role of Microbiome in BCG Responsiveness Prediction
- ClinicalTrials.gov ID
- NCT05204199
- Acronym / sponsor ID
- SILENTEMPIRE / 2021-01783
- Conditions
- Microbiome, Bladder Cancer
- Keywords
- BCG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cédric PoyetUniversity, hospital or other
- Collaborators
- Krebsliga Schweiz
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 24 Jan 2022 (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.
Our primary aim is to investigate the use of microbial profile from the bladder and the feces of NMIBC patients as a predicting tool for therapy response prior to BCG administration.
Our second aim is to collect additional samples (blood, instrumented urine, bladder tissue, feces) to establish a local biobank for future microbiome projects.
Detailed description
The microbiome, defined as a characteristic microbial community occupying a reasonably well-defined environment (e.g. gut microbiome), has been increasingly linked with different medical conditions and also with cancer. While there have been numerous investigations into the gut bacterial ecosystem, scientists have started to pay attention to the microbiome of the bladder only recently. Results from newest investigations support the understanding that the bladder possesses its own microbiome and it is not germ-free. Studying the relationship between bladder cancer and bladder and gut microbiome may lead to new insights which can be used to predict tumor behavior and/or response to therapy.
With this project, we aim to investigate the use of microbial fingerprint from the bladder and from the feces of bladder cancer patients in predicting therapy response prior to administration of Bacillus Calmette-Guerin or BCG. BCG causes the body's own immune system to attack the bladder cancer cells. It is applied directly into the bladder to prevent the cancer from growing and from regrowing. However, in around 40% of patients this treatment is not successful, BCG should be avoided, and other therapy strategies should be chosen. Unfortunately, there is no test available yet, which help to select patients who will benefit from the therapy before the therapy is started.
In this project we intend to determine the microbial fingerprint and to analyze if this fingerprint can be used as a selection tool. This tool may enable as us in the future to avoid application of BCG therapy for patient with a high risk of therapy failure and save time to start alternative therapy options and hopefully avoid tumor progression. Our second aim is to collect additional samples (blood, instrumented urine, bladder tissue, feces) to establish a local biobank for future microbiome projects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Patients without a urological or gastrointestinal malignancy undergoing non-oncological bladder surgery or transurethral resection of the prostate (TUR-P) |
| Group B | – | –Low Risk NMIBC (primary, solitary, Ta / low grad < 3cm, no carcinoma in situ (CIS)) |
| Group C | – | –NMIBC patients, BCG candidates, assessed as intermediate (between the category of low- and high risk) or high risk (T1 or high grade or CIS or multiple, recurrent and large (> 3 cm) Ta/ low grade tumours). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group A: Patients without a urological or gastrointestinal malignancy undergoing non-oncological bladder surgery or transurethral resection of the prostate (TUR-P) fulfilling the following criteria. At the time of study inclusion, no urological symptoms or relevant urological disease (Unclear Macrohematuria, Cystolithiasis, prostate Cancer ) Group B: Low Risk NMIBC (primary, solitary, Ta / low grad < 3cm, no carcinoma in situ (CIS)). Group C: NMIBC patients, BCG candidates, assessed as intermediate (between the category of low- and high risk) or high risk (T1 or high grade or CIS or multiple, recurrent and large (> 3 cm) Ta/ low grade tumours).
Key inclusion criteria (3 listed)
- Signed informed consent
- Ability to understand and follow study procedures and understand informed consent
- age 18 - 90 years
Key exclusion criteria (9 listed)
- Antibiotic treatment within the last month
- Immuno-/chemotherapy within the past 6 months
- Immunosuppressive therapy
- Major medical, neoplastic (with the exception of skin cancer), surgical or psychiatric condition requiring ongoing management. Minor, well-controlled conditions, such as medically controlled arterial hypertension or occupational asthma, may be present.
- Additional major diagnosis known to affect the gut or bladder microbiota (e. g. liver cirrhosis, systemic sclerosis, inflammatory bowel disease, inflammatory bowel syndrome, celiac disease, neuropathic bladder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in microbial Profile
Time frame: 1 year
use of microbial profile from the bladder and the feces of NMIBC patients as a potential binary classification system, to substratify BCG-candidates into "anticipated BCG-responder (aBCGr)" and "anticipated BCG-non-responder (aBCGnr)" groups in predicting therapy response prior to BCG administration.
1 secondary outcome
Biobank
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Derived from this study: PubMed 35437256Bieri U, Scharl M, Sigg S, Szczerba BM, Morsy Y, Ruschoff JH, Schraml PH, Krauthammer M, Hefermehl LJ, Eberli D, Poyet C. Prospective observational study of the role of the microbiome in BCG responsiveness prediction (SILENT-EMPIRE): a study protocol. BMJ Open. 2022 Apr 18;12(4):e061421. doi: 10.1136/bmjopen-2022-061421.
- 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. This study is not recruiting at the moment.
Cédric Poyed, MD principal investigator
University Hospital Zurich, Departement of Urology
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbiome and Bladder Cancer, run by Cédric Poyet at 5 sites in Switzerland.
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 9 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: status not confirmed, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uwe Bieri, MD (+41792998114, uwe.bieri@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in microbial Profile (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05204199, which also lists 1 linked publication.
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 Apr 2024.