BioForte Technology for in Silico Identification of Candidates for a New Microbiome-based Therapeutics and Diagnostics
- Conditions
- MetagenomeMelanomaNon Small Cell Lung CancerImmunotherapyMicrobiome
- Interventions
- Biological: Collection of stool, blood (PBMC) and biopsy (FFPE)
- Registration Number
- NCT04136470
- Lead Sponsor
- Ardigen
- 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
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 130
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description NSCLC Collection of stool, blood (PBMC) and biopsy (FFPE) This cohort will consist of 100 patients with non-small cell lung cancer (NSCLC). MEL Collection of stool, blood (PBMC) and biopsy (FFPE) This cohort will consist of 30 patients with melanoma (MEL).
- Primary Outcome Measures
Name Time Method Microbial diversity in stool samples Inclusion Microbila DNA - stool samples sequenced by long-read sequencing technology.
Number of Responders and Non-responders on immunotherapy (evaluated using RECIST 1.1 criteria) Up to 6 months Standard follow-up care after cancer treatment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
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
The Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw
🇵🇱Warsaw, Poland
University Clinical Centre in Gdansk
🇵🇱Gdańsk, Poland
Mountains Center of Pulmonology and Chemotherapy "Izer-Med"
🇵🇱Szklarska Poręba, Poland
Masovian Oncology Hospital in Wieliszew
🇵🇱Wieliszew, Poland
The John Paul II Hospital in Krakow
🇵🇱Kraków, Poland
Specialist Oncological Hospital
🇵🇱Tomaszów Mazowiecki, Poland
Lower Silesian Oncology Center & Łukasiewicz Research Network - PORT Polish Center For Technology Development
🇵🇱Wrocław, Poland