Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05060757
Other study ID # Biotax_001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Terminated NCT04555135 - A Clinical Study To Measure The Effect Of Use Of Artificial Intelligence (AI) Enabled Computer Aided Detection (CADe) Assistance Software In Detecting Colon Polyps During Standard Colonoscopy Procedures N/A
Completed NCT03390907 - Hybrid APC Assisted EMR for Large Colon Polyps N/A
Completed NCT03551379 - A Double Balloon Endoscopic Platform for ESD
Recruiting NCT05405530 - Nasal Mask Kit in Gastrointestinal Endoscopy N/A
Completed NCT05030870 - Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients N/A
Completed NCT03742232 - Study Comparing the Bowel Cleansing Efficacy of PLENVU® Versus SELG-ESSE® Using a 2-Day Split Dosing Regimen. Phase 4
Completed NCT03444090 - Impacts of Inspection During Instrument Insertion on Colonoscopy Quality N/A
Enrolling by invitation NCT03700593 - Feasibility and Safety of Single Port Robot in Colorectal Procedures
Recruiting NCT04063280 - Prospective Randomized Controlled Trial Describing the Recurrence Rate of Adenomas in Sessile or Flat Colonic Lesions 15mm or Larger Receiving Post-resection Site Treatment With Snare Tip Soft Coagulation N/A
Completed NCT04378088 - The Colon Endoscopic Bubble Scale (CEBuS); Validation Study
Completed NCT03891290 - Collecting Recorded Videos of Colonoscopy Screening Tests
Terminated NCT04628052 - The Effect of Music on Colonoscopy (MUSICOL) N/A
Terminated NCT05579444 - Systems Biology of Gastrointestinal and Related Diseases
Not yet recruiting NCT06317727 - PULSed Field ablAtion of coloRectal Polyps
Active, not recruiting NCT04369053 - Prevention of Colorectal Cancer Through Multiomics Blood Testing
Completed NCT03329339 - The Effect of 1L Polyethylene Glycol Plus Ascorbic Acid With Prepackaged Low-Residue Diet for Bowel Preparation N/A
Completed NCT03943758 - a Low-residue Diet for Bowel Preparation N/A
Not yet recruiting NCT04837690 - UEMR for Medium-sized Pedunculated Colon Polyps
Recruiting NCT03803891 - Endoscopic Full-Thickness Resection In Colon

External Links