Microbiome Test for the Detection of Colorectal Polyps

Not Applicable

• Conditions: Colon Polyp
• Interventions: Diagnostic Test: biotax

• Registration Number: NCT05060757
• Lead Sponsor: Biotax Labs LTD

Brief 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.

Detailed 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 Timeline

• Study Start: 2021-07-27
• Status Verified: 2021-09
• Study First Submitted: 2021-09-19
• Study First Submitted QC: 2021-09-19
• Last Update Submitted: 2021-09-19
• Study First Posted: 2021-09-29
• Last Update Posted: 2021-09-29
• Primary Completion: 2022-07
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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

Exclusion Criteria

1. Subject has a history of colorectal cancer (CRC)

2. 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")

3. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD), including chronic ulcerative colitis or Crohn's disease.

4. Patients with incapacitating systemic disease

5. Any use of antibiotics within one months prior to colonoscopy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
colonoscopy	biotax	Participants will be patients undergoing colonoscopy

Primary Outcome Measures

Name	Time	Method
diagnose existence of colon polyps	year	To determine whether fecal metagenomics microbial signatures can significantly predict adenoma\\ sessile serrated polyps (SSP) existence in patients and serve as diagnostic biomarkers.

Secondary Outcome Measures

Name	Time	Method
Saliva microbiome vs stool microbiome	year	To determine if Saliva microbiome sample can provide indication same as Stool microbiome sample.
diagnose sub types of colon polyps	year	To determine whether fecal metagenomics microbial signatures can significantly identify between the following subgroups: non-polyp group, Hyperplastic polyps, adenomas - \<5 mm, 6-10mm polyp group and \>10mm polyp group.

Trial Locations

Locations (2)

Rambam Medical Center; 🇮🇱 Haifa, Israel

Assuta Medical Center; 🇮🇱 Tel Aviv, Israel