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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 : August 10, 2020
Sponsor:
Collaborator:
National Center for Research and Development, Poland
Information provided by (Responsible Party):
Ardigen

Study Description
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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).


Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Microbiome Metagenome Immunotherapy Melanoma Biological: Collection of stool, blood (PBMC) and biopsy (FFPE)

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Groups and Cohorts
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Group/Cohort Intervention/treatment
NSCLC
This cohort will consist of 100 patients with non-small cell lung cancer (NSCLC).
 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:
  • Nivolumab
  • Ipilimumab
  • Atezolizumab
MEL
This cohort will consist of 30 patients with melanoma (MEL).
 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:
  • Nivolumab
  • Ipilimumab
  • Atezolizumab


Outcome Measures
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Primary Outcome Measures :
  1. Microbial diversity in stool samples [ Time Frame: Inclusion ]
    Microbila DNA - stool samples sequenced by long-read sequencing technology.

  2. 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
stool, biopsy (FFPE) and peripheral blood samples (PBMC)

Eligibility Criteria
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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
Study Population
Patients receiving routine treatment.
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Martyna Balawejder +48 883 319 890 martyna.balawejder@ardigen.com
Contact: Bozena Augustyn +48 12 340 94 94 bozena.augustyn@ardigen.com

Locations
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Poland
University Clinical Centre in Gdansk Recruiting
Gdańsk, Poland
The John Paul II Hospital in Krakow Recruiting
Kraków, Poland
The Maria Sklodowska-Curie National Research Institute of Oncology Krakow Branch Not yet recruiting
Kraków, Poland
Poznań University Hospital of Lord's Transfiguration Withdrawn
Poznań, 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
Wrocław, Poland
Sponsors and Collaborators
Ardigen
National Center for Research and Development, Poland
Investigators
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Principal Investigator: Michal Warchol, PhD Ardigen
More Information
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Responsible Party: Ardigen
ClinicalTrials.gov Identifier: NCT04136470    
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: August 10, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ardigen:
Microbiome
Cancer
Metagenome
Non Small Cell Lung Cancer
Immunotherapy
Neoplasms
Nivolumab
Ipilimumab
 Atezolizumab
Stool
FFPE
PBMC
Intestinal microbiota
Immuno-Oncology
Melanoma
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Melanoma
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
 Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Nivolumab
Ipilimumab
Atezolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action