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| ID | Type | Description | Link |
|---|---|---|---|
| POIR.01.01.01-00-0347/17 | Other Grant/Funding Number | The National Centre for Research and Development |
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| Name | Class |
|---|---|
| National Center for Research and Development, Poland | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSCLC | This cohort will consist of 100 patients with non-small cell lung cancer (NSCLC). |
| |
| MEL | This cohort will consist of 30 patients with melanoma (MEL). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of stool, blood (PBMC) and biopsy (FFPE) | Biological | Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving routine treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martyna Balawejder | Contact | +48 883 319 890 | martyna.balawejder@ardigen.com | |
| Bozena Augustyn | Contact | +48 12 340 94 94 | bozena.augustyn@ardigen.com |
| Name | Affiliation | Role |
|---|---|---|
| Michal Warchol, PhD | Ardigen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinical Centre in Gdansk | Recruiting | Gdansk | Poland | |||
| The John Paul II Hospital in Krakow |
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stool, biopsy (FFPE) and peripheral blood samples (PBMC)
|
| Recruiting |
| Krakow |
| Poland |
| The Maria Sklodowska-Curie National Research Institute of Oncology Krakow Branch | Not yet recruiting | Krakow | Poland |
| Poznań University Hospital of Lord's Transfiguration | Withdrawn | Poznan | Poland |
| Provincial Hospital St. Father Pio in Przemyśl | Recruiting | Przemyśl | Poland |
| Mountains Center of Pulmonology and Chemotherapy "Izer-Med" | Recruiting | Szklarska Poręba | Poland |
| Specialist Oncological Hospital | Recruiting | Tomaszów Mazowiecki | Poland |
| The Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw | Recruiting | Warsaw | Poland |
| Masovian Oncology Hospital in Wieliszew | Recruiting | Wieliszew | Poland |
| Lower Silesian Oncology Center & Łukasiewicz Research Network - PORT Polish Center For Technology Development | Withdrawn | Wroclaw | Poland |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008545 | Melanoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D001706 | Biopsy |
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| C000594389 | atezolizumab |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D003949 | Diagnostic Techniques, Surgical |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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