跳至主要内容
临床试验/NCT04136470
NCT04136470Unknown不适用

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

Ardigen10 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2019年4月1日最近更新:
适应症

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

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

研究者

发起方
Ardigen
申办方类型
Industry
责任方
Sponsor

研究点 (10)

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