The goal of the project is to develop and validate the BioForte technology. Its main functionality should be to in silico determine candidates for novel microbiome-based therapeutics and diagnostics. Key challenge to be solved using the technology is to detect the differences in gut microbiome between oncology patients who respond to immunotherapies and the ones who do not respond to this treatment. This technology employs machine learning methods to replace the laboratory procedure for finding valuable genomic features. Such features can be crucial to identify differences between the two populations (e.g. responders vs non-responders) to target specific strains. The samples and data collected in this clinical study will be used for clinical validation of BioForte technology. For all patients treated with immunotherapy, stool collection will be performed per patient (one stool collection before setting up immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies). Samples will be sequenced by long-read sequencing technology. In parallel, we will also collect samples of peripheral blood samples (PBMC) and biopsy (FFPE).
Study Type
OBSERVATIONAL
Enrollment
130
Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).
University Clinical Centre in Gdansk
Gdansk, Poland
RECRUITINGThe John Paul II Hospital in Krakow
Krakow, Poland
RECRUITINGThe Maria Sklodowska-Curie National Research Institute of Oncology Krakow Branch
Krakow, Poland
NOT_YET_RECRUITINGPoznań University Hospital of Lord's Transfiguration
Poznan, Poland
WITHDRAWNProvincial Hospital St. Father Pio in Przemyśl
Przemyśl, Poland
RECRUITINGMountains Center of Pulmonology and Chemotherapy "Izer-Med"
Szklarska Poręba, Poland
RECRUITINGSpecialist Oncological Hospital
Tomaszów Mazowiecki, Poland
RECRUITINGThe Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw
Warsaw, Poland
RECRUITINGMasovian Oncology Hospital in Wieliszew
Wieliszew, Poland
RECRUITINGLower Silesian Oncology Center & Łukasiewicz Research Network - PORT Polish Center For Technology Development
Wroclaw, Poland
WITHDRAWNMicrobial diversity in stool samples
Microbila DNA - stool samples sequenced by long-read sequencing technology.
Time frame: Inclusion
Number of Responders and Non-responders on immunotherapy (evaluated using RECIST 1.1 criteria)
Standard follow-up care after cancer treatment.
Time frame: Up to 6 months
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