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

August 7, 2020 updated by: Ardigen

Development of BioForte Technology for in Silico Identification of Valuable Genomic Features That Are Candidates for Microbiome-based Therapeutics and Diagnostics.

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdańsk, Poland
        • Recruiting
        • University Clinical Centre in Gdansk
      • Kraków, Poland
        • Recruiting
        • The John Paul II Hospital in Krakow
      • Kraków, Poland
        • Not yet recruiting
        • The Maria Sklodowska-Curie National Research Institute of Oncology Krakow Branch
      • Poznań, Poland
        • Withdrawn
        • Poznań University Hospital of Lord's Transfiguration
      • Przemyśl, Poland
        • Recruiting
        • Provincial Hospital St. Father Pio in Przemyśl
      • Szklarska Poręba, Poland
        • Recruiting
        • Mountains Center of Pulmonology and Chemotherapy "Izer-Med"
      • Tomaszów Mazowiecki, Poland
        • Recruiting
        • Specialist Oncological Hospital
      • Warsaw, Poland
        • Recruiting
        • The Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw
      • Wieliszew, Poland
        • Recruiting
        • Masovian Oncology Hospital in Wieliszew
      • Wrocław, Poland
        • Withdrawn
        • Lower Silesian Oncology Center & Łukasiewicz Research Network - PORT Polish Center For Technology Development

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving routine treatment.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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:
  • Atezolizumab
  • Nivolumab
  • Ipilimumab
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:
  • Atezolizumab
  • Nivolumab
  • Ipilimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 6 months
Microbial diversity in stool samples
Time Frame: Inclusion
Microbila DNA - stool samples sequenced by long-read sequencing technology.
Inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ardigen

Collaborators

National Center for Research and Development, Poland

Investigators

  • Principal Investigator: Michal Warchol, PhD, Ardigen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2019

Primary Completion (ANTICIPATED)

September 30, 2020

Study Completion (ANTICIPATED)

March 31, 2021

Study Registration Dates

First Submitted

October 18, 2019

First Submitted That Met QC Criteria

October 21, 2019

First Posted (ACTUAL)

October 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 10, 2020

Last Update Submitted That Met QC Criteria

August 7, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BioForte
  • POIR.01.01.01-00-0347/17 (OTHER_GRANT: The National Centre for Research and Development)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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