Status:
UNKNOWN
BioForte Technology for in Silico Identification of Candidates for a New Microbiome-based Therapeutics and Diagnostics
Lead Sponsor:
Ardigen
Collaborating Sponsors:
National Center for Research and Development, Poland
Conditions:
Non Small Cell Lung Cancer
Microbiome
Eligibility:
All Genders
18+ years
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2021
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04136470
Start Date
April 1 2019
End Date
March 31 2021
Last Update
August 10 2020
Active Locations (10)
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1
University Clinical Centre in Gdansk
Gdansk, Poland
2
The John Paul II Hospital in Krakow
Krakow, Poland
3
The Maria Sklodowska-Curie National Research Institute of Oncology Krakow Branch
Krakow, Poland
4
Poznań University Hospital of Lord's Transfiguration
Poznan, Poland