Clinical trial NCT04136470: 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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Cancer
Microbiome
Metagenome
Immunotherapy
Melanoma
Keywords: Microbiome
Cancer
Metagenome
Non Small Cell Lung Cancer
Immunotherapy
Neoplasms
Nivolumab
Ipilimumab
Atezolizumab
Stool
FFPE
PBMC
Intestinal microbiota
Immuno-Oncology
Melanoma
Lead sponsor: Ardigen
Sponsor class: INDUSTRY
Collaborators: name: National Center for Research and Development, Poland
First posted: 2019-10-23
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving routine treatment.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Microbial diversity in stool samples
timeFrame: Inclusion
measure: Number of Responders and Non-responders on immunotherapy (evaluated using RECIST 1.1 criteria)
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: University Clinical Centre in Gdansk
city: Kraków
country: Poland
facility: The John Paul II Hospital in Krakow
city: Kraków
country: Poland
facility: The Maria Sklodowska-Curie National Research Institute of Oncology Krakow Branch
city: Poznań
country: Poland
facility: Poznań University Hospital of Lord's Transfiguration
city: Przemyśl
country: Poland
facility: Provincial Hospital St. Father Pio in Przemyśl
city: Szklarska Poręba
country: Poland
facility: Mountains Center of Pulmonology and Chemotherapy "Izer-Med"
city: Tomaszów Mazowiecki
country: Poland
facility: Specialist Oncological Hospital
city: Warsaw
country: Poland
facility: The Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw
city: Wieliszew
country: Poland
facility: Masovian Oncology Hospital in Wieliszew
city: Wrocław
country: Poland
facility: Lower Silesian Oncology Center & Łukasiewicz Research Network - PORT Polish Center For Technology Development
Study officials:
affiliation: Ardigen
name: Michal Warchol, PhD
role: PRINCIPAL_INVESTIGATOR
References: