Microbiome Test for the Detection of Colorectal Polyps

  • STATUS
    Recruiting
  • End date
    Dec 6, 2022
  • participants needed
    600
  • sponsor
    Biotax Labs LTD
Updated on 6 October 2021
colonoscopy
colorectal polyps

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.

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.

Details
Condition COLONIC POLYP
Treatment biotax
Clinical Study IdentifierNCT05060757
SponsorBiotax Labs LTD
Last Modified on6 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Males or females
Age: 45-70 years, inclusive
Patients without any incapacitating systemic disease
Able to comprehend and provide informed consent
Patients who are scheduled / planned to undergo a colonoscopy, preferably: participants who are undergoing a colonoscopy as a diagnostic surveillance

Exclusion Criteria

Subject has a history of colorectal cancer (CRC)
Subject has a diagnosis or medical history of any of the following conditions
Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome)
Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome")
Subject has a diagnosis or personal history of inflammatory bowel disease (IBD), including chronic ulcerative colitis or Crohn's disease
Patients with incapacitating systemic disease
Any use of antibiotics within one months prior to colonoscopy
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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