Non Small Cell Lung CancerNCT04136470
BioForte Technology for in Silico Identification of Candidates for a New Microbiome-based Therapeutics and Diagnostics
An observational study of Non Small Cell Lung Cancer and Microbiome, run by Ardigen at 10 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Microbiome, Metagenome
- What is being tested?
- Collection of stool, blood (PBMC) and biopsy (FFPE)
- How many people
- 130 participants
- Where
- 10 sitesPoland
- Study dates
- 1 Apr 2019to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving routine treatment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Poland10 sites, 8 recruiting
- Recruiting
University Clinical Centre in Gdansk
Gdansk
- Recruiting
The John Paul II Hospital in Krakow
Krakow
- Not yet recruiting
The Maria Sklodowska-Curie National Research Institute of Oncology Krakow Branch
Krakow
- Withdrawn
Poznań University Hospital of Lord's Transfiguration
Poznan
- Recruiting
Provincial Hospital St. Father Pio in Przemyśl
Przemyśl
- Recruiting
Mountains Center of Pulmonology and Chemotherapy "Izer-Med"
Szklarska Poręba
- Recruiting
Specialist Oncological Hospital
Tomaszów Mazowiecki
- Recruiting
The Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw
Warsaw
- Recruiting
Masovian Oncology Hospital in Wieliszew
Wieliszew
- Withdrawn
Lower Silesian Oncology Center & Łukasiewicz Research Network - PORT Polish Center For Technology Development
Wroclaw
About this study
Official title: 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).
- Conditions
- Non Small Cell Lung Cancer, Microbiome, Metagenome, Immunotherapy, Melanoma
- Being tested
- Collection of stool, blood (PBMC) and biopsy (FFPE)
- Keywords
- Microbiome, Cancer, Metagenome, Non Small Cell Lung Cancer, Immunotherapy, Neoplasms, Nivolumab, Ipilimumab, Atezolizumab, Stool, FFPE, PBMC, Intestinal microbiota, Immuno-Oncology, Melanoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Melanoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of stool, blood (PBMC) and biopsy (FFPE)Biological
Also called Nivolumab, Ipilimumab, Atezolizumab
Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).
| Study group | Role | What they receive |
|---|---|---|
| NSCLC | This cohort will consist of 100 patients with non-small cell lung cancer (NSCLC). Receives: Biological: Collection of stool, blood (PBMC) and biopsy (FFPE) | |
| MEL | This cohort will consist of 30 patients with melanoma (MEL). Receives: Biological: Collection of stool, blood (PBMC) and biopsy (FFPE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial diversity in stool samples
Microbila DNA - stool samples sequenced by long-read sequencing technology.
Measured: Inclusion
Number of Responders and Non-responders on immunotherapy (evaluated using RECIST 1.1 criteria)
Standard follow-up care after cancer treatment.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start1 Apr 2019
- Primary completion30 Sep 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ardigen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Responsible party
- Sponsor
- Investigators
- Michal Warchol, PhD, Principal investigator, Ardigen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136470
- Sponsor's protocol ID
- BioForte
- Other IDs
- POIR.01.01.01-00-0347/17
- Status last verified
- Aug 2020
- First submitted
- 18 Oct 2019
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of BioForte Technology for in Silico Identification of Valuable Genomic Features That Are Candidates for Microbiome-based Therapeutics and Diagnostics.
- ClinicalTrials.gov ID
- NCT04136470
- Acronym / sponsor ID
- BioForte
- Conditions
- Non Small Cell Lung Cancer, Microbiome, Metagenome, Immunotherapy, Melanoma
- Keywords
- Microbiome, Cancer, Metagenome, Non Small Cell Lung Cancer, Immunotherapy, Neoplasms, Nivolumab, Ipilimumab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- ArdigenIndustry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSCLC | – | Biological: Collection of stool, blood (PBMC) and biopsy (FFPE)This cohort will consist of 100 patients with non-small cell lung cancer (NSCLC). |
| MEL | – | Biological: Collection of stool, blood (PBMC) and biopsy (FFPE)This cohort will consist of 30 patients with melanoma (MEL). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving routine treatment.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of stool, blood (PBMC) and biopsy (FFPE)Also: Nivolumab, Ipilimumab, AtezolizumabPatients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ). | Biological | MEL, NSCLC |
Primary outcome
Microbial diversity in stool samples
Time frame: Inclusion
Microbila DNA - stool samples sequenced by long-read sequencing technology.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michal Warchol, PhD principal investigator
Ardigen
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer and Microbiome, run by Ardigen at 10 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martyna Balawejder (+48 883 319 890, martyna.balawejder@ardigen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial diversity in stool samples (time frame: Inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2020.