Microbiome Test for the Detection of Colorectal Polyps
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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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.
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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.
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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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- Saliva microbiome vs stool microbiome [year]
To determine if Saliva microbiome sample can provide indication same as Stool microbiome sample.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males or females.
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Age: 45-70 years, inclusive.
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Patients without any incapacitating systemic disease
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Able to comprehend and provide informed consent.
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Patients who are scheduled / planned to undergo a colonoscopy, preferably: participants who are undergoing a colonoscopy as a diagnostic surveillance.
Exclusion Criteria:
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Subject has a history of colorectal cancer (CRC)
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Subject has a diagnosis or medical history of any of the following conditions:
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Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome)
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Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome")
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Subject has a diagnosis or personal history of inflammatory bowel disease (IBD), including chronic ulcerative colitis or Crohn's disease.
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Patients with incapacitating systemic disease
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Any use of antibiotics within one months prior to colonoscopy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rambam Medical Center | Haifa | Israel | ||
| 2 | Assuta Medical Center | Tel Aviv | Israel |
Sponsors and Collaborators
- Biotax Labs LTD
Investigators
- Principal Investigator: Zohar Levi, MD, Assuta Medical Center
- Principal Investigator: Erez Hasnis, MD, Rambam Health Care Campus
Study Documents (Full-Text)
None provided.More Information
Additional Information:
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.
- 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.
- Biotax_001