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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04136470
• Other study ID #: BioForte
• Secondary ID: POIR.01.01.01-00
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: August 2020
• Source: Ardigen
• Contact: Martyna Balawejder
• Phone: +48 883 319 890
• Email: martyna.balawejder[@]ardigen.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: March 31, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Immunotherapy
• Melanoma
• Metagenome
• Microbiome
• Non Small Cell Lung Cancer

Intervention

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).

Locations

Country	Name	City	State
Poland	University Clinical Centre in Gdansk	Gdansk
Poland	The John Paul II Hospital in Krakow	Kraków
Poland	The Maria Sklodowska-Curie National Research Institute of Oncology Krakow Branch	Kraków
Poland	Poznan University Hospital of Lord's Transfiguration	Poznan
Poland	Provincial Hospital St. Father Pio in Przemysl	Przemysl
Poland	Mountains Center of Pulmonology and Chemotherapy "Izer-Med"	Szklarska Poreba
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 & Lukasiewicz Research Network - PORT Polish Center For Technology Development	Wroclaw

Sponsors (2)

Lead Sponsor	Collaborator
Ardigen	The National Centre for Research and Development

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbial diversity in stool samples	Microbila DNA - stool samples sequenced by long-read sequencing technology.	Inclusion
Primary	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