Microbiome Test for the Detection of Colorectal Polyps

Status Recruiting

Clinical Trial Summary

The main goal of this trial is to validate a new method for colorectal polyp screening based on stool microbiome signatures. 600 Individuals who are scheduled / planned to undergo a colonoscopy will be recruited for this study and a stool sample and an optional saliva sample will be collected. Analyze process will be conducted on the microbiome of the samples given.

Clinical Trial Description

Colorectal cancer (CRC) is the second cause of cancer death in the US. The pathogenesis of CRC is complex, involving a progressive transition of the healthy colonic mucosa to pre-cancerous polyps, and eventually to CRC. One of the factors that are proposed to cause this 'adenoma-carcinoma sequence' is the dysbiosis of the gut microbiome. The gut microbiota has been identified as a potential screening biomarker for CRC, since studies have reported specific bacterial taxa and/ or microbial signatures as important factors in the etiology of CRC. Hypothesis: comprehensive and cutting-edge metagenomic analysis of the fecal microbiome of individuals with colonic polyps vs. patients without polyps will identify microbial signatures associated with colonic polyps and will define these microbial signatures as biomarkers and risk factors for CRC. method: - Collect data (anthropometric, demographic, dietary, lifestyle habits, medical and family history) and stool & optional Saliva sample for microbiome analysis from a cohort of 600 colonoscopies screened individuals. - Analyze this data with an aim to utilize advanced artificial intelligence and machine-learning techniques to classified microbiome signatures, which are correlated to colonoscopy (and to histological) results. - Blinded Validation - A sub-cohort of 300 individuals (who are part of the 600 individuals) that were not used to classify the biomarkers signatures will be used to validate the diagnosis model. Data analysis: The stool and optional Saliva samples will be sent to metagenomic sequencing, thereby generating FASTQ libraries of the reads found in the stool & saliva samples. These files will be analyzed by the BiotaX diagnostics platform. No Human DNA analysis will take place at this clinical study. Only a microbial analysis will take place. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05060757
Study type	Interventional
Source	Biotax Labs LTD
Contact	Shay Hilel
Phone	+972-54-4386721
Email	shay@biotax.co
Status	Recruiting
Phase	N/A
Start date	July 27, 2021
Completion date	December 2022

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.