BioForte Technology for in Silico Identification of Candidates for a New Microbiome-based Therapeutics and Diagnostics

Last updated: August 7, 2020
Sponsor: Ardigen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Melanoma

Vaccines

Chemotherapy

Treatment

N/A

Clinical Study ID

NCT04136470
BioForte
POIR.01.01.01-00-0347/17
  • Ages > 18
  • All Genders

Study 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

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

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.

Study Design

Total Participants: 130
Study Start date:
April 01, 2019
Estimated Completion Date:
March 31, 2021

Connect with a study center

  • University Clinical Centre in Gdansk

    Gdańsk,
    Poland

    Active - Recruiting

  • The John Paul II Hospital in Krakow

    Kraków,
    Poland

    Active - Recruiting

  • The Maria Sklodowska-Curie National Research Institute of Oncology Krakow Branch

    Kraków,
    Poland

    Site Not Available

  • Poznań University Hospital of Lord's Transfiguration

    Poznań,
    Poland

    Site Not Available

  • Provincial Hospital St. Father Pio in Przemyśl

    Przemyśl,
    Poland

    Active - Recruiting

  • Mountains Center of Pulmonology and Chemotherapy "Izer-Med"

    Szklarska Poręba,
    Poland

    Active - Recruiting

  • Specialist Oncological Hospital

    Tomaszów Mazowiecki,
    Poland

    Active - Recruiting

  • The Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw

    Warsaw,
    Poland

    Active - Recruiting

  • Masovian Oncology Hospital in Wieliszew

    Wieliszew,
    Poland

    Active - Recruiting

  • Lower Silesian Oncology Center & Łukasiewicz Research Network - PORT Polish Center For Technology Development

    Wrocław,
    Poland

    Site Not Available

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