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Brief Title: BioForte Technology for in Silico Identification of Candidates for a New Microbiome-based Therapeutics and Diagnostics
Official Title: Development of BioForte Technology for in Silico Identification of Valuable Genomic Features That Are Candidates for Microbiome-based Therapeutics and Diagnostics.
Study ID: NCT04136470
Brief Summary: 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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University Clinical Centre in Gdansk, Gdańsk, , Poland
The John Paul II Hospital in Krakow, Kraków, , Poland
The Maria Sklodowska-Curie National Research Institute of Oncology Krakow Branch, Kraków, , Poland
Poznań University Hospital of Lord's Transfiguration, Poznań, , Poland
Provincial Hospital St. Father Pio in Przemyśl, Przemyśl, , Poland
Mountains Center of Pulmonology and Chemotherapy "Izer-Med", Szklarska Poręba, , Poland
Specialist Oncological Hospital, Tomaszów Mazowiecki, , Poland
The Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw, Warsaw, , Poland
Masovian Oncology Hospital in Wieliszew, Wieliszew, , Poland
Lower Silesian Oncology Center & Łukasiewicz Research Network - PORT Polish Center For Technology Development, Wrocław, , Poland
Name: Michal Warchol, PhD
Affiliation: Ardigen
Role: PRINCIPAL_INVESTIGATOR