Clinical trial NCT05060757: Microbiome Test for the Detection of Colorectal Polyps
Official title: Microbiome Test for the Detection of Colorectal Polyps
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Polyp
Keywords: Colonoscopy
microbiome
colon polyp
Lead sponsor: Biotax Labs LTD
Sponsor class: INDUSTRY
First posted: 2021-09-29
Enrollment: 600
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: diagnose existence of colon polyps
timeFrame: year
Secondary outcomes:
measure: diagnose sub types of colon polyps
timeFrame: year
measure: Saliva microbiome vs stool microbiome
timeFrame: year
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Tel Aviv
country: Israel
facility: Assuta Medical Center
Study officials:
affiliation: Assuta Medical Center
name: Zohar Levi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: Erez Hasnis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Garrett WS. The gut microbiota and colon cancer. Science. 2019 Jun 21;364(6446):1133-1135. doi: 10.1126/science.aaw2367. No abstract available.
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.