Immunotherapy, Melanoma, Metagenome, Microbiome, Non Small Cell Lung Cancer
Conditions
Keywords
Microbiome, Cancer, Metagenome, Non Small Cell Lung Cancer, Immunotherapy, Neoplasms, Nivolumab, Ipilimumab, Atezolizumab, Stool, FFPE, PBMC, Intestinal microbiota, Immuno-Oncology, Melanoma
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).
Interventions
BIOLOGICALCollection of stool, blood (PBMC) and biopsy (FFPE)
Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).
Sponsors
National Center for Research and Development, Poland
Ardigen
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Poland
Contacts
Backup ContactBozena Augustyn
Primary ContactMartyna Balawejder
Outcome results
None listed