Microbiome Test for the Detection of Colorectal Polyps

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.

Study Overview

• Status: Recruiting
• Conditions: Colon Polyp
• Intervention / Treatment: Diagnostic test: biotax

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 Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shay Hilel; Phone Number: +972-54-4386721; Email: shay@biotax.co
• Study Contact Backup: Name: Naama Geva-Zatorsky, Ph.D; Phone Number: +972-52-292-2300; Email: naamagz@biotax.co

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Rambam Medical Center
    • Contact: Erez Hasnis, MD
  • Tel Aviv, Israel
    • Recruiting
    • Assuta Medical Center
    • Contact: Zohar Levi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: colonoscopy; Participants will be patients undergoing colonoscopy	Diagnostic test: biotax; patients who are scheduled to undergo colonoscopy will be asked to participate and give a stool sample

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnose sub types of colon polyps	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.	year
Saliva microbiome vs stool microbiome	To determine if Saliva microbiome sample can provide indication same as Stool microbiome sample.	year

Collaborators and Investigators

• Sponsor: Biotax Labs LTD
• Investigators: Principal Investigator: Zohar Levi, MD, Assuta Medical Center; Principal Investigator: Erez Hasnis, MD, Rambam Health Care Campus

Publications and helpful links

General Publications

• Dadkhah E, Sikaroodi M, Korman L, Hardi R, Baybick J, Hanzel D, Kuehn G, Kuehn T, Gillevet PM. Gut microbiome identifies risk for colorectal polyps. BMJ Open Gastroenterol. 2019 May 27;6(1):e000297. doi: 10.1136/bmjgast-2019-000297. eCollection 2019.
• Garrett WS. The gut microbiota and colon cancer. Science. 2019 Jun 21;364(6446):1133-1135. doi: 10.1126/science.aaw2367. No abstract available.
• Thomas AM, Manghi P, Asnicar F, Pasolli E, Armanini F, Zolfo M, Beghini F, Manara S, Karcher N, Pozzi C, Gandini S, Serrano D, Tarallo S, Francavilla A, Gallo G, Trompetto M, Ferrero G, Mizutani S, Shiroma H, Shiba S, Shibata T, Yachida S, Yamada T, Wirbel J, Schrotz-King P, Ulrich CM, Brenner H, Arumugam M, Bork P, Zeller G, Cordero F, Dias-Neto E, Setubal JC, Tett A, Pardini B, Rescigno M, Waldron L, Naccarati A, Segata N. Author Correction: Metagenomic analysis of colorectal cancer datasets identifies cross-cohort microbial diagnostic signatures and a link with choline degradation. Nat Med. 2019 Dec;25(12):1948. doi: 10.1038/s41591-019-0663-4.

Helpful Links

• colorectal cancer statistics

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: September 19, 2021
• First Submitted That Met QC Criteria: September 19, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 19, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Colonoscopy; microbiome; colon polyp
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Polyps; Polyps; Colonic Polyps
• Other Study ID Numbers: Biotax_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No