Microbiome Test for the Detection of Colorectal Polyps

Colon Polyp Clinical Trial

Official title:

Microbiome Test for the Detection of Colorectal Polyps

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05060757
• Other study ID #: Biotax_001
• Status: Recruiting
• Phase: N/A
• Start date: July 27, 2021
• Est. completion date: December 2022

Study information

• Verified date: September 2021
• Source: Biotax Labs LTD
• Contact: Shay Hilel
• Phone: +972-54-4386721
• Email: shay[@]biotax.co
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colon Polyp
• Colonic Polyps
• Polyps

Intervention

Diagnostic Test:
• biotax
patients who are scheduled to undergo colonoscopy will be asked to participate and give a stool sample

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa
Israel	Assuta Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Biotax Labs LTD

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View Citation

Garrett WS. The gut microbiota and colon cancer. Science. 2019 Jun 21;364(6446):1133-1135. doi: 10.1126/science.aaw2367. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Saliva microbiome vs stool microbiome	To determine if Saliva microbiome sample can provide indication same as Stool microbiome sample.	year

External Links

•   colorectal cancer statistics