BioForte Technology for in Silico Identification of Candidates for a New Microbiome-based Therapeutics and Diagnostics

Study Overview
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Brief Summary
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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).

Official Title
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Development of BioForte Technology for in Silico Identification of Valuable Genomic Features That Are Candidates for Microbiome-based Therapeutics and Diagnostics.

Conditions
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Non Small Cell Lung Cancer, Microbiome, Metagenome, Immunotherapy, Melanoma

Intervention / Treatment
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* Biological: Collection of stool, blood (PBMC) and biopsy (FFPE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women ≥18 years of age. Patients with one of the following types of cancer: non-small cell lung cancer, melanoma. Patients with informed consent to participate in the study. Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ). The applied immunotherapy should be the first or second line of treatment. Exclusion Criteria: Patients who are unable to understand, read and / or sign informed consent. Patients who can not collect stools. Patients with fecal transplant. The applied immunotherapy is not the first or second line of treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NSCLC<br>This cohort will consist of 100 patients with non-small cell lung cancer (NSCLC). | Biological: Collection of stool, blood (PBMC) and biopsy (FFPE)<br>* Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).<br>* Other names: Atezolizumab;|
| MEL<br>This cohort will consist of 30 patients with melanoma (MEL). | Biological: Collection of stool, blood (PBMC) and biopsy (FFPE)<br>* Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).<br>* Other names: Atezolizumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbial diversity in stool samples | Microbila DNA - stool samples sequenced by long-read sequencing technology. | Inclusion | 
| Number of Responders and Non-responders on immunotherapy (evaluated using RECIST 1.1 criteria) | Standard follow-up care after cancer treatment. | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiome, Cancer, Metagenome, Non Small Cell Lung Cancer, Immunotherapy, Neoplasms, Nivolumab, Ipilimumab, Atezolizumab, Stool, FFPE, PBMC, Intestinal microbiota, Immuno-Oncology, Melanoma