Role of Microbiome in BCG Responsiveness Prediction

NCT ID: NCT05204199

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-22
• Study Completion Date: 2025-10-20

Brief 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.

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.

Conditions

Microbiome; Bladder Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A

Patients without a urological or gastrointestinal malignancy undergoing non-oncological bladder surgery or transurethral resection of the prostate (TUR-P)

No interventions assigned to this group

Group B

Low Risk NMIBC (primary, solitary, Ta / low grad \< 3cm, no carcinoma in situ (CIS))

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Signed informed consent
• Ability to understand and follow study procedures and understand informed consent
• age 18 - 90 years

Exclusion Criteria

• 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.
• Major gastrointestinal symptoms (diarrhoea, constipation, abdominal pain, vomiting, unexplained weight loss, rectal bleeding or blood in the stool)
• Bladder augmentation surgery.
• Indwelling urinary catheter

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Krebsliga Schweiz

UNKNOWN

Sponsor Role: collaborator

Cédric Poyet

OTHER

Sponsor Role: lead

Responsible Party

Cédric Poyet

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Cédric Poyed, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Departement of Urology

Locations

Kantonsspital Baden

Baden, Canton of Aargau, Switzerland

Site Status: RECRUITING

Spitalzentrum Biel

Biel/Bienne, Canton of Bern, Switzerland

Site Status: NOT_YET_RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

Site Status: RECRUITING

Kantonsspital Winterthur

Winterthur, Canton of Zurich, Switzerland

Site Status: RECRUITING

University Hospital Zürich

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Uwe Bieri, MD

Role: CONTACT

uwe.bieri@usz.ch

+41792998114

Facility Contacts

Lukas J. Hefermehl, MD

Role: primary

lukas.hefermehl@ksb.ch

Roland Seiler-Blarer, Prof.

Role: primary

roland.seiler-blarer@szb-chb.ch

Daniel Engeler, MD

Role: primary

daniel.engeler@kssg.ch

Beat Förster, MD

Role: primary

beat.foerster@ksw.ch

Cédric Poyet, MD

Role: primary

cedric.poyet@usz.ch

0041 44 255 11 11

References

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.

Reference Type: DERIVED

PMID: 35437256 (View on PubMed)

Other Identifiers

2021-01783

Identifier Type: -

Identifier Source: org_study_id