BioForte Technology for in Silico Identification of Candidates for a New Microbiome-based Therapeutics and Diagnostics
Development of BioForte Technology for in Silico Identification of Valuable Genomic Features That Are Candidates for Microbiome-based Therapeutics and Diagnostics.
2 other identifiers
observational
130
1 country
10
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2019
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 18, 2019
CompletedFirst Posted
Study publicly available on registry
October 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedAugust 10, 2020
August 1, 2020
1.5 years
October 18, 2019
August 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
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).
Interventions
Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).
Eligibility Criteria
Patients receiving routine treatment.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ardigenlead
- National Center for Research and Development, Polandcollaborator
Study Sites (10)
University Clinical Centre in Gdansk
Gdansk, Poland
The John Paul II Hospital in Krakow
Krakow, Poland
The Maria Sklodowska-Curie National Research Institute of Oncology Krakow Branch
Krakow, Poland
Poznań University Hospital of Lord's Transfiguration
Poznan, Poland
Provincial Hospital St. Father Pio in Przemyśl
Przemyśl, Poland
Mountains Center of Pulmonology and Chemotherapy "Izer-Med"
Szklarska Poręba, Poland
Specialist Oncological Hospital
Tomaszów Mazowiecki, Poland
The Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw
Warsaw, Poland
Masovian Oncology Hospital in Wieliszew
Wieliszew, Poland
Lower Silesian Oncology Center & Łukasiewicz Research Network - PORT Polish Center For Technology Development
Wroclaw, Poland
Biospecimen
stool, biopsy (FFPE) and peripheral blood samples (PBMC)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michal Warchol, PhD
Ardigen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2019
First Posted
October 23, 2019
Study Start
April 1, 2019
Primary Completion
September 30, 2020
Study Completion
March 31, 2021
Last Updated
August 10, 2020
Record last verified: 2020-08