Role of Microbiome in BCG Responsiveness Prediction

NCT05204199 | Recruiting

• 1 other identifier: 2021-01783
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 5

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.

Conditions

Microbiome; Bladder Cancer

Keywords

BCG

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• Biobank

  1 year

Study Arms (3)

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).

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cédric Poyet: lead
• Krebsliga Schweiz: collaborator

Study Sites (5)

Kantonsspital Baden

Baden, Canton of Aargau, 5404, Switzerland

RECRUITING

Spitalzentrum Biel

Biel/Bienne, Canton of Bern, 2501, Switzerland

NOT YET RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

RECRUITING

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

RECRUITING

University Hospital Zürich

Zurich, 8091, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 35437256 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bladder tissue samples, fecal samples, Instrumented urine samples, blood samples

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Cédric Poyed, MD

  University Hospital Zurich, Departement of Urology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uwe Bieri, MD

CONTACT

+41792998114; uwe.bieri@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 24, 2022
• Study Start: February 22, 2022
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (5)