BioForte Technology for in Silico Identification of Candidates for a New Microbiome-based Therapeutics and Diagnostics
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ClinicalTrials.gov Identifier: NCT04136470 |
Recruitment Status :
Recruiting
First Posted : October 23, 2019
Last Update Posted : October 28, 2019
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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).
Condition or disease | Intervention/treatment |
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Non Small Cell Lung Cancer Renal Cell Carcinoma Microbiome Metagenome Immunotherapy | Biological: Collection of stool, blood (PBMC) and biopsy (FFPE) |
Study Type : | Observational |
Estimated Enrollment : | 130 participants |
Observational Model: | Case-Only |
Time Perspective: | Cross-Sectional |
Official Title: | Development of BioForte Technology for in Silico Identification of Valuable Genomic Features That Are Candidates for Microbiome-based Therapeutics and Diagnostics. |
Actual Study Start Date : | April 1, 2019 |
Estimated Primary Completion Date : | September 30, 2020 |
Estimated Study Completion Date : | March 31, 2021 |

Group/Cohort | Intervention/treatment |
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NSCLC
This cohort will consist of 100 patients with non-small cell lung cancer (NSCLC).
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Biological: Collection 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).
Other Names:
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RCC
This cohort will consist of 30 patients with renal cell carcinoma (RCC).
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Biological: Collection 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).
Other Names:
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- Microbial diversity in stool samples [ Time Frame: 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) [ Time Frame: Up to 6 months ]Standard follow-up care after cancer treatment.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Men or women ≥18 years of age.
- Patients with one of the following types of cancer: non-small cell lung cancer, renal cell carcinoma.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04136470
Contact: Emilia Strycharz-Angrecka | +48 12 340 94 94 | emilia.strycharz-angrecka@ardigen.com | |
Contact: Bozena Augustyn | +48 12 340 94 94 | bozena.augustyn@ardigen.com |
Poland | |
University Clinical Centre in Gdansk | Recruiting |
Gdańsk, Poland | |
The John Paul II Hospital in Krakow | Not yet recruiting |
Kraków, Poland | |
Lower Silesian Oncology Center & Łukasiewicz Research Network - PORT Polish Center For Technology Development | Recruiting |
Wrocław, Poland |
Principal Investigator: | Michal Warchol, PhD | Ardigen |
Responsible Party: | Ardigen |
ClinicalTrials.gov Identifier: | NCT04136470 History of Changes |
Other Study ID Numbers: |
BioForte POIR.01.01.01-00-0347/17 ( Other Grant/Funding Number: The National Centre for Research and Development ) |
First Posted: | October 23, 2019 Key Record Dates |
Last Update Posted: | October 28, 2019 |
Last Verified: | October 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Microbiome Cancer Metagenome Non Small Cell Lung Cancer Renal Cell Carcinoma Immunotherapy Neoplasms Nivolumab |
Ipilimumab Atezolizumab Stool FFPE PBMC Intestinal microbiota Immuno-Oncology |
Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Nivolumab Ipilimumab Atezolizumab Coal Tar Antineoplastic Agents, Immunological Antineoplastic Agents Keratolytic Agents Dermatologic Agents |