NCT05060757

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

September 19, 2021

Last Update Submit

September 19, 2021

Conditions

Colon Polyp

Keywords

Colonoscopymicrobiomecolon polyp

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • diagnose sub types of colon polyps

    year

  • Saliva microbiome vs stool microbiome

    year

Study Arms (1)

colonoscopy

EXPERIMENTAL

Participants will be patients undergoing colonoscopy

Diagnostic Test: biotax

Interventions

biotaxDIAGNOSTIC_TEST

patients who are scheduled to undergo colonoscopy will be asked to participate and give a stool sample

colonoscopy

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females.
  • Age: 45-70 years, inclusive.
  • Patients without any incapacitating systemic disease
  • Able to comprehend and provide informed consent.
  • Patients who are scheduled / planned to undergo a colonoscopy, preferably: participants who are undergoing a colonoscopy as a diagnostic surveillance.

You may not qualify if:

  • Subject has a history of colorectal cancer (CRC)
  • 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")
  • Subject has a diagnosis or personal history of inflammatory bowel disease (IBD), including chronic ulcerative colitis or Crohn's disease.
  • Patients with incapacitating systemic disease
  • Any use of antibiotics within one months prior to colonoscopy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rambam Medical Center

Haifa, Israel

RECRUITING

Assuta Medical Center

Tel Aviv, Israel

RECRUITING

Related 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.

    PMID: 31275588BACKGROUND

  • Garrett WS. The gut microbiota and colon cancer. Science. 2019 Jun 21;364(6446):1133-1135. doi: 10.1126/science.aaw2367. No abstract available.

    PMID: 31221845BACKGROUND

  • 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.

    PMID: 31664237BACKGROUND

Related Links

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Zohar Levi, MD

    Assuta Medical Center

    PRINCIPAL INVESTIGATOR

  • Erez Hasnis, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shay Hilel

CONTACT

+972-54-4386721shay@biotax.co

Naama Geva-Zatorsky, Ph.D

CONTACT

+972-52-292-2300naamagz@biotax.co

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2021

First Posted

September 29, 2021

Study Start

July 27, 2021

Primary Completion

July 1, 2022

Study Completion

December 1, 2022

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(2)