Role of Microbiome in BCG Responsiveness Prediction

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme

Rekrutierend

NCT-Nummer:
NCT05204199

Studienbeginn:
Februar 2022

Letztes Update:
05.04.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Urinary Bladder Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Cédric Poyet

Collaborator:
Krebsliga Schweiz

Studienleiter

Cédric Poyed, MD
Principal Investigator
University Hospital Zurich, Departement of Urology

Kontakt

Uwe Bieri, MD
Kontakt:
Phone: +41792998114
E-Mail: uwe.bieri@usz.ch» Kontaktdaten anzeigen

Studienlocations
(3 von 5)

Kantonsspital Baden
5404 Baden
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Lukas J. Hefermehl, MD
E-Mail: lukas.hefermehl@ksb.ch» Ansprechpartner anzeigen

Spitalzentrum Biel
2501 Biel
SwitzerlandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Roland Seiler-Blarer, Prof.
E-Mail: roland.seiler-blarer@szb-chb.ch» Ansprechpartner anzeigen

Kantonsspital St. Gallen
9007 St. Gallen
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Daniel Engeler, MD
E-Mail: daniel.engeler@kssg.ch» Ansprechpartner anzeigen

Kantonsspital Winterthur
8401 Winterthur
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Beat Förster, MD
E-Mail: beat.foerster@ksw.ch» Ansprechpartner anzeigen

University Hospital Zürich
8091 Zürich
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Cédric Poyet, MD
Phone: 0041 44 255 11 11
E-Mail: cedric.poyet@usz.ch» Ansprechpartner anzeigen

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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.

Secondary outcome:

1. Biobank (Time Frame - 1 year):
collect additional samples (blood, instrumented urine, bladder tissue, feces) to establish a local biobank for future microbiome projects

Studien-Arme

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).

Quelle: ClinicalTrials.gov

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