Artificial Intelligence-Assisted Colonoscopy in Colorectal Cancer Screening in a General Hospital

NCT06792292 | Not Yet Recruiting

• 1 other identifier: 2024 Chirec Delta Colo-AI
• Study Type: interventional
• Target: 765
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer can develop in the colon, or large bowel. Examination of the colon with a tube fitted with a camera is called a colonoscopy. Colonoscopy allows detection of small growths in the colon, called "polyps". Polyps can often be removed during colonoscopy. Some of these polyps are called adenomas and can become cancer after several years. A good colonoscopy aims to find and take out as many of these polyps as possible. A quality indication of colonoscopy is the "adenoma detection rate" (ADR). It should be high, meaning many polyps are detected and taken out. New artificial intelligence devices to assist colonoscopy seem to increase the ADR, and maybe help prevent cancer even better than normal colonoscopy. The goal of this clinical trial is to compare the ADR when using standard colonoscopy to the ADR with artificial intelligence (AI)-assisted colonoscopy.

Conditions

Artificial Intelligence; Colonic Adenoma; Colonic Neoplasms; Colonic Polyp; Colonoscopy

Keywords

colo-rectal cancer screening; artificial intelligence assisted colonoscopy

Outcome Measures

Primary Outcomes (1)

• Adenoma Detection Rate in Conventional versus Artificial Intelligence-Assisted Colonoscopy

  The main objective of this study is the difference in the detection rate of colorectal adenomas in individuals over 45 years old during colonoscopies for colon cancer screening between a conventional colonoscopy procedure (CCP) and a colonoscopy procedure with AI (ACP).

  1 day

Secondary Outcomes (8)

• The difference in the detection rate of colorectal adenomas according to size by group (5 mm/6-9 mm/>10 mm) between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP).

  1 day

• The difference in the detection rate of colorectal adenomas according to the number per group (n=1-2/n= 3-10/n >10) between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP).

  1 day

• The difference in the detection rate of colorectal adenomas based on histology by group (hyperplastic/conventional adenomas/serrated adenomas/adenocarcinoma) between a conventional colonoscopic procedure (PCC) and a colonoscopy procedure with AI.

  1 month

• The difference in detection rate of colorectal adenomas based on dysplastic grade by group

  1 day

• The difference in the detection rate of colorectal adenomas depending on the location by group (rectum/left colon/transverse colon/right colon) between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP).

  1 day

Study Arms (2)

CCP: conventional colonoscopy procedure

ACTIVE COMPARATOR

The conventional colonoscopy arm subjects will undergo a screening colonoscopy without assistance from artificial intelligence.

Other: conventional colonoscopy procedure

ACP: artificial intelligence-assisted colonoscopy procedure

ACTIVE COMPARATOR

The artificial intelligence-assisted colonoscopy arm subjects will undergo a screening colonoscopy with assistance from an artificial intelligence module.

Other: artificial intelligence-assisted colonoscopy procedure

Interventions

conventional colonoscopy procedure OTHER

Study subjects in this interventional arm will undergo conventional colonoscopy.

CCP: conventional colonoscopy procedure

artificial intelligence-assisted colonoscopy procedure OTHER

Study subjects in this interventional arm will undergo colonoscopy done with a commercially-available module that uses artificial intelligence to highlight suspected polyps on the screen during colonoscopy. This module also attempts to characterize the detected polyp as adenomatous or not. The detection and characterization of polyps is in real time, during the procedure.

ACP: artificial intelligence-assisted colonoscopy procedure

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient (woman or man) candidate for a screening colonoscopy - Age: 45 to 74 years included
• Absence of inflammatory bowel disease
• Absence of significant digestive symptoms indicating colonoscopy (i.e. screening is the only indication for the examination)
• Patient able to understand the concept of the study and agreeing to participate

You may not qualify if:

• The indication for colonoscopy is not simple screening; for example, assessment of anemia, rectal bleeding, weight loss or abdominal pain.
• Patient's refusal to participate, or patient's inability to understand the study concept
• Any patient with major psychological or psychiatric disorders.

Sponsors & Collaborators

• Chirec: lead

Study Sites (1)

Hopital Delta Chirec

Auderghem, Brussels Capital, 1160, Belgium

Location

Related Publications (8)

• Spadaccini M, Marco A, Franchellucci G, Sharma P, Hassan C, Repici A. Discovering the first US FDA-approved computer-aided polyp detection system. Future Oncol. 2022 Apr;18(11):1405-1412. doi: 10.2217/fon-2021-1135. Epub 2022 Jan 27.

  PMID: 35081745 BACKGROUND

• Repici A, Badalamenti M, Maselli R, Correale L, Radaelli F, Rondonotti E, Ferrara E, Spadaccini M, Alkandari A, Fugazza A, Anderloni A, Galtieri PA, Pellegatta G, Carrara S, Di Leo M, Craviotto V, Lamonaca L, Lorenzetti R, Andrealli A, Antonelli G, Wallace M, Sharma P, Rosch T, Hassan C. Efficacy of Real-Time Computer-Aided Detection of Colorectal Neoplasia in a Randomized Trial. Gastroenterology. 2020 Aug;159(2):512-520.e7. doi: 10.1053/j.gastro.2020.04.062. Epub 2020 May 1.

  PMID: 32371116 BACKGROUND

• Gupta S, Lieberman D, Anderson JC, Burke CA, Dominitz JA, Kaltenbach T, Robertson DJ, Shaukat A, Syngal S, Rex DK. Recommendations for Follow-Up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer. Gastrointest Endosc. 2020 Mar;91(3):463-485.e5. doi: 10.1016/j.gie.2020.01.014. Epub 2020 Feb 7. No abstract available.

  PMID: 32044106 BACKGROUND

• Kaminski MF, Thomas-Gibson S, Bugajski M, Bretthauer M, Rees CJ, Dekker E, Hoff G, Jover R, Suchanek S, Ferlitsch M, Anderson J, Roesch T, Hultcranz R, Racz I, Kuipers EJ, Garborg K, East JE, Rupinski M, Seip B, Bennett C, Senore C, Minozzi S, Bisschops R, Domagk D, Valori R, Spada C, Hassan C, Dinis-Ribeiro M, Rutter MD. Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) quality improvement initiative. United European Gastroenterol J. 2017 Apr;5(3):309-334. doi: 10.1177/2050640617700014. Epub 2017 Mar 16.

  PMID: 28507745 BACKGROUND

• Hassan C, Antonelli G, Dumonceau JM, Regula J, Bretthauer M, Chaussade S, Dekker E, Ferlitsch M, Gimeno-Garcia A, Jover R, Kalager M, Pellise M, Pox C, Ricciardiello L, Rutter M, Helsingen LM, Bleijenberg A, Senore C, van Hooft JE, Dinis-Ribeiro M, Quintero E. Post-polypectomy colonoscopy surveillance: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2020. Endoscopy. 2020 Aug;52(8):687-700. doi: 10.1055/a-1185-3109. Epub 2020 Jun 22.

  PMID: 32572858 BACKGROUND

• Brenner H, Hoffmeister M, Stegmaier C, Brenner G, Altenhofen L, Haug U. Risk of progression of advanced adenomas to colorectal cancer by age and sex: estimates based on 840,149 screening colonoscopies. Gut. 2007 Nov;56(11):1585-9. doi: 10.1136/gut.2007.122739. Epub 2007 Jun 25.

  PMID: 17591622 BACKGROUND

• Saftoiu A, Hassan C, Areia M, Bhutani MS, Bisschops R, Bories E, Cazacu IM, Dekker E, Deprez PH, Pereira SP, Senore C, Capocaccia R, Antonelli G, van Hooft J, Messmann H, Siersema PD, Dinis-Ribeiro M, Ponchon T. Role of gastrointestinal endoscopy in the screening of digestive tract cancers in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2020 Apr;52(4):293-304. doi: 10.1055/a-1104-5245. Epub 2020 Feb 12.

  PMID: 32052404 BACKGROUND

• Hassan C, Spadaccini M, Iannone A, Maselli R, Jovani M, Chandrasekar VT, Antonelli G, Yu H, Areia M, Dinis-Ribeiro M, Bhandari P, Sharma P, Rex DK, Rosch T, Wallace M, Repici A. Performance of artificial intelligence in colonoscopy for adenoma and polyp detection: a systematic review and meta-analysis. Gastrointest Endosc. 2021 Jan;93(1):77-85.e6. doi: 10.1016/j.gie.2020.06.059. Epub 2020 Jun 26.

  PMID: 32598963 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms; Colonic Polyps

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Denis Franchimont, M.D., PhD

  Chirec

  STUDY CHAIR

Central Study Contacts

Erik Francois, M.D.

CONTACT

32 495 77 00 60; drfrancois.chirec@gmail.com

Philippe Langlet, M.D.

CONTACT

32 2 434 8105; philippe.langlet@chirec.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Arm 1- Conventional colonoscopy Arm 2- Colonoscopy assisted by artificial intelligence system

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: January 24, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The investigators anticipate that data will be available within six months after the completion of the trial and publication of the primary findings, and for a period of one year thereafter.
• Access Criteria: Access to the data will be available to qualified researchers, with requests submitted by contacting one of the investigators.

Locations

BE (1)