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Adult patients with a positive FIT-test will breath into an e-nose device for 5 minutes.

An electronic nose device is an artificial olfactory system that analyses volate organic compounds (VOCs) in exhaled breath. The AeonoseTM is a handheld device of 650 gram. A nose clip will be used to prevent the entry of non-filtered air and patients will be instructed to enclose the mouthpiece with their mouth at all times. A measurement cycle lasts for about 15 minutes, of which 5 minutes of in-and exhalation by the patient takes place.

Aeonose

Peter D Siersema, MD

The present study aims to investigate the diagnostic accuracy of exhaled breath analysis with the Aeonose (the eNose Company, Zutphen, the Netherlands) to distinguish the breath of patients suspected for CRC (based on a positive fecal immunochemical test), who are truly diagnosed with CRC, from patients suspected for CRC in whom this diagnosis is rejected after colonoscopy.

Study rationale:

Colonoscopy plays a key role in all colorectal cancer (CRC) screening modalities. An important limitation of colonoscopy remains that the diagnostic accuracy and therapeutic safety of colonoscopy both depend on several physician and patient-related factors. Significant amounts of polyps are missed during colonoscopy and severe untoward effects still occur in 0.1%-0.3% of all colonoscopy procedures, even among expert examiners. Moreover, the burdensome nature of the procedure and the necessity of full bowel preparation negatively influences participation rates and the use of colonoscopy as a CRC screening test is limited by healthcare costs and the expertise needed to perform the screening. These disadvantages of colonoscopy warrant the development of a new, non-invasive, accurate CRC screening test.

An electronic nose device is an artificial olfactory system that analyses volate organic compounds (VOCs) in exhaled breath. The use of electronic noses has already been assessed as a potential non-invasive diagnostic biomarker test for lung cancer, breast cancer and malignant melanomas. The present study aims to investigate the diagnostic accuracy of exhaled breath analysis with the AeonoseTM (The eNose Company, Zutphen, the Netherlands) to distinguish the breath of patients suspected for CRC (based on a positive fecal immunochemical test (FIT)), who are truly diagnosed with CRC, from patients suspected for CRC in whom this diagnosis is rejected after colonoscopy.

Objectives:

* To investigate the diagnostic accuracy of exhaled breath analysis with the AeonoseTM to distinguish the breath of patients suspected for CRC based on a positive FIT test, who are truly diagnosed with CRC, from patients suspected for CRC in whom this diagnosis is rejected after colonoscopy.
* To investigate the diagnostic accuracy of exhaled breath analysis with the AeonoseTM for other (pre-)malignant colon lesions (e.g. advanced adenomas, non-advanced adenomas, and sessile serrated lesions).
* To assess the acceptance rate of using the AeonoseTM device.

Study design: The present multicenter study will include 1950 FIT-positive patients. The study will be conducted in seven hospitals in the Netherlands. First a database of breath prints will be developed to detect CRC. In this study phase the AeonoseTM will be trained and the database of breath prints will be verified using "leave 10% out" cross validation. After the calibration phase the diagnostic accuracy of AeonoseTM will be assessed in new study patients (external validation).

Study population: Patients between the ages of 55 and 75 years old with a positive FIT-test referred for a colonoscopy procedure.

Main study parameters/endpoints:

* The ability of AeonoseTM to distinguish between patients with and without CRC in a FIT-positive population in terms of sensitivity and specificity.
* The diagnostic accuracy of AeonoseTM for other (pre-)malignant colon lesions.
* Acceptance rate of AeonoseTM

Statistical analysis:

Data on demographic and baseline characteristics will be summarized for continuous variables, in case of normal distribution by mean and standard deviation, and in case of non-normal distribution by median and interquartile range. For discrete variables (eg, race and sex) data will be summarized by proportions (percentages). Differences in baseline characteristics will be determined using independent sample t test, Fisher's exact test or Chi-square test, when appropriate. A 2-sided p-value \<0.05 will be considered statistically significant.

The data will be analyzed by an artificial neural network (ANN) to identify data classifiers to extract differences between the patterns in patients by the presence or absence of CRC in biopsies. By analyzing a group of breath prints from patients with and without CRC, individual differences of diet, medications, co-morbidities, and other factors can be filtered out to identify features that distinguish the compounds of patients with CRC. This process continues until a selected level of discrimination is met. Data compression and ANN have been integrated in a proprietary software package (Aethena) of the eNose Company (Zutphen, the Netherlands).

The binary results will be presented in a scatterplot and a receiver operating characteristics curve (ROC-curve). Matthews correlation coefficients will be calculated to measure the quality of binary classifications. Cross-validation of the data will be performed using a leave-10%-out method. A portion of the data is left out to predict the most optimal model.

Detection of Colorectal Cancer in Patients With a Positive Fecal Immunochemical Test Using an Electronic Nose Device (AeoNoseTM)

Sensitivity and specificity of the Aeonose

Willingness to repeat the procedure and discomfort during test

Radboud University Medical Center

Recurrence

Adenoma

Neoplasm Recurrence, Local

Disease Attributes

Neoplastic Processes

Post procedural prophylactic coagulation of the entire margin of the resection site creating a 2-3mm rim.

Thermal ablation of the entire resection margin

Snare tip soft coagulation

Gijs Kemper, MD

Gijs Kemper

Peter Siersema

The primary objective of this trial is to investigate whether thermal ablation EMR with soft tip snare coagulation (STSC) reduces the recurrence rate of lateral spreading or sessile polyps ≥20mm compared to standard EMR.

Rationale:

Lowering the EMR recurrence rate will potentially lead to fewer colonoscopies resulting in less additional costs, less compliance burdens and less exposure to possible procedure related risks.

Objective:

To investigate whether thermal ablation EMR with snare tip soft coagulation (STSC) reduces the recurrence rate of lateral spreading or sessile polyps ≥20mm compared to standard EMR.

Study design:

This study entails a patient-blinded multicenter prospective randomized controlled trial that will be conducted between January 2022 and May 2025 in 1 academic and 7 non-academic hospitals in The Netherlands and it will take place in the outpatient clinics of the participating centers.

Study population:

All patients aged ≥ 18 years with proven colorectal sessile of lateral spreading polyps (Paris classification 0-IIa/b/c, Is) with a diameter of ≥ 20mm requiring piecemeal resection with EMR are eligible for inclusion.

Intervention:

Snare tip soft coagulation of the entire EMR margin is a technique for the removal of potential residual adenoma.

Main study endpoint:

Polyp recurrence after 6 months follow up. Recurrence is evaluated histologically and endoscopically with biopsies taken during follow up colonoscopy.

Recurrences After Standard EMR vs Plus Thermal Ablation EMR

Recurrences After Standard EMR vs Plus Thermal Ablation EMR of Advanced Sessile and Lateral Spreading Colorectal Adenoma

There is no particular plan. But the investigators are willing to share the data with colleagues depending which research question they want to answer.

Maas Hospital Pantein

Evangelisches Krankenhaus Düsseldorf

Catharina Ziekenhuis Eindhoven

Bernhoven Hospital

Maasstad Hospital

St Jansdal Hospital

Bravis Hospital

ENDOMIND

Alexander Hann

Evaluation of an artificial intelligence system for polyp detection (CADe)

We aim to evaluate the artificial intelligence system ENDOMIND that supports endoscopist in detection of polyps during surveillance endoscopy for colorectal cancer. 1070 patients out of 6 gastroenterologic practice are randomized 1:1 for conventional surveillance colonoscopy vs. surveillance with AI support. Primary endpoint is Adenoma detection rate.

Surveillance Modified by Artificial Intelligence in Endoscopy (SMARTIE)

Multicenter Evaluation Study of the CADe System ENDOMIND in Surveillance Endoscopy for Colorectal Cancer in German Outpatient Cohort

proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas

Exmainations with minimum one polyp detected.

minimum 0, Maximum 9; should be higher than 5 for appropriate surveillance

Klinikum Stuttgart

Wuerzburg University Hospital

Carcinoma

Rectal Neoplasms

Adenocarcinoma

Colonic Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Herbal and Botanical

All Drugs and Chemicals

Cola

Patients undergoing colonoscopy with artificial intelligence.

Patients undergoing colonoscopy with standard colonscopy

We wanted to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy (SC) in a FIT-positive screening population.

CADe colonoscopy using GI Genius device

Sebastian Manuel Milluzzo, MD

Paola Cesaro, MD, PhD

Paola Cesaro, MD, Phd

Cristiano Spada, MD, PhD

Even if colonoscopy is considered the reference standard for the detection of colonic neoplasia, polyps are still missed. The risk of early post-colonoscopy cancer appeared to be independently predicted by a relatively low polyp/adenoma detection rate. When considering the very high prevalence of advanced neoplasia in the FIT-positive enriched population, the risk of post-colonoscopy interval cancer due to a suboptimal quality of colonoscopy may be substantial. Available evidence justifies therefore the implementation of efforts aimed at improving adenoma detection rate, based on retraining interventions and on the adoption of innovative technologies, designed to enhance the accuracy of the endoscopic examination. Artificial intelligence seems to improve the quality of medical diagnosis and treatment. In the field of gastrointestinal endoscopy, two potential roles of AI in colonoscopy have been examined so far: automated polyp detection (CADe) and automated polyp histology characterization (CADx). CADe can minimize the probability of missing a polyp during colonoscopy, thereby improving the adenoma detection rate (ADR) and potentially decreasing the incidence of interval cancer. GI Genius is the AI software that will be used in the present trial and is intended to be used as an adjunct to colonic endoscopy procedures to help endoscopists to detect in real time mucosal lesions (such as polyps and adenomas, including those with flat (non-polypoid) morphology) during standard screening and surveillance endoscopic mucosal evaluations. It is not intended to replace histopathological sampling as a means of diagnosis.

The objective of this study was to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy (SC).

Even if colonoscopy is considered the reference standard for the detection of colonic neoplasia, polyps are still missed. In large administrative cohort or case-control studies, the risk of early post-colonoscopy cancer appeared to be independently predicted by a relatively low polyp/adenoma detection rate. The adenoma detection rate among different endoscopists has been shown to be strictly related with the risk of post-colonoscopy interval cancer. When considering the very high prevalence of advanced neoplasia in the FIT-positive enriched population, the risk of post-colonoscopy interval cancer due to a suboptimal quality of colonoscopy may be substantial. Available evidence justifies therefore the implementation of efforts aimed at improving adenoma detection rate, based on retraining interventions and on the adoption of innovative technologies, designed to enhance the accuracy of the endoscopic examination.Nowadays, Artificial intelligence (AI) is gaining increased attention and investigation, since it seems to improve the quality of medical diagnosis and treatment. In the field of gastrointestinal endoscopy, two potential roles of AI in colonoscopy have been examined so far: automated polyp detection (CADe) and automated polyp histology characterization (CADx). CADe can minimize the probability of missing a polyp during colonoscopy, thereby improving the adenoma detection rate (ADR) and potentially decreasing the incidence of interval cancer. GI Genius is the AI software that will be used in the present trial. The software is developed by Medtronic Inc. (Dublin, Ireland) and is intended to be used as an adjunct to colonic endoscopy procedures to help endoscopists to detect in real time mucosal lesions (such as polyps and adenomas, including those with flat (non-polypoid) morphology) during standard screening and surveillance endoscopic mucosal evaluations. It is not intended to replace histopathological sampling as a means of diagnosis.

The objective of this study was to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy (SC). As the risk of progression is higher for large than for small adenomas the specific contribution of the new technique in reducing the miss rate of large neoplasms represents an important outcome to be assessed in the study. In addition, given the suggested association of a higher miss-rate of serrated and flat lesions with an increased risk of early post-colonoscopy CRC, the benefit of the new technique in reducing the miss rate of these lesions will be assessed.

Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in a Screening Setting

Resa Diagnostica Aggiuntiva Dell'Intelligenza Artificiale Nella Colonscopia (GENIAL COLONOSCOPY), Per lo Screening Del Carcinoma Colorettale

The percentage of patients with adenomas with high-grade displasia in CADe colonoscopy group will be recorded and compared with the rate of patients with adenomas with high-grade displasia in standard colonoscopy group.

The percentage of patients with 3 or more adenomas (serrated adenomas will also be considered in the calculation) in CADe colonoscopy group will be compared with the rate of patients with 3 or more adenomas (including serrated adenomas) in standard colonoscopy group.

The percentage of adenomas, polyps (in general), flat adenoma and serrated polyps/adenoma detected will be recorded and compared between the groups.

The size of lesion detected will be measured in millimiters and compared between the groups.

The percentage of patients with neoplasia of proximal (right colonic segments) or distal (left colonic segments and rectum) site will be assessed and compared between the groups.

the time interval, expressed in years, to the next suggested follow-up colonoscopy will be assessed and compared between the groups.

The time to reach the cecum will be measured in minutes, recorded and compared between the groups.

The time of withdrawal (from cecum to anus) and of the overall colonoscopy (from anus to anus) will be measured in minutes, recorded and compared between the groups.

The above-mentioned outcomes will be calculated for each endoscopist at 3, 6, 9 and 12 months.

Visual Analogue Scale (VAS) (0 minimum to 10 maximum) will be recorded to assess the pain before and after the colonoscopy and results will be compared between the groups.

Proportion of patients diagnosed with polyps which were detected only by Artificial intelligence

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Detection of Colorectal Cancer in Patients With a Positive Fecal Immunochemical Test Using an Electronic Nose Device (AeoNoseTM)	NCT03346005	Colorectal Canc... Polyps of Colon	Aeonose	55 Years - 75 Years	Radboud University Medical Center
Recurrences After Standard EMR vs Plus Thermal Ablation EMR	NCT05121805	Polyps of Colon Recurrence, Loc...	Snare tip soft ...	18 Years -	Radboud University Medical Center
Surveillance Modified by Artificial Intelligence in Endoscopy (SMARTIE)	NCT05006092	Surveillance En... Artificial Inte... Polyps of Colon CADe	ENDOMIND	18 Years -	Wuerzburg University Hospital
Recurrences After Standard EMR vs Plus Thermal Ablation EMR	NCT05121805	Polyps of Colon Recurrence, Loc...	Snare tip soft ...	18 Years -	Radboud University Medical Center
Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in a Screening Setting	NCT04441580	Colonic Neoplas... Colonic Adenoca... Polyps of Colon Rectal Neoplasm... Rectal Adenocar...	CADe colonoscop...	50 Years - 69 Years	Fondazione Poliambulanza Istituto Ospedaliero
Surveillance Modified by Artificial Intelligence in Endoscopy (SMARTIE)	NCT05006092	Surveillance En... Artificial Inte... Polyps of Colon CADe	ENDOMIND	18 Years -	Wuerzburg University Hospital
Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in a Screening Setting	NCT04441580	Colonic Neoplas... Colonic Adenoca... Polyps of Colon Rectal Neoplasm... Rectal Adenocar...	CADe colonoscop...	50 Years - 69 Years	Fondazione Poliambulanza Istituto Ospedaliero

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