Development of BioForte Technology for in Silico Identification of Valuable Genomic Features That Are Candidates for Microbiome-based Therapeutics and Diagnostics.
试验速览
- 阶段
- 不适用
- 发起方
- Ardigen
- 入组人数
- 130
- 试验地点
- 10
- 主要终点
- Microbial diversity in stool samples
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Microbial diversity in stool samples
时间窗: 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)
时间窗: Up to 6 months
Standard follow-up care after cancer treatment.
次要结局
未报告次要终点
