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Neoplasms by Histologic Type

Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled. Participants will undergo blood collection and will then complete a standard-of-care screening colonoscopy.

Freenome test

Aasma Shaukat, MD MPH

Theodore R Levin, MD

Lance Baldo, MD

The PREEMPT CRC study is a prospective multi-center observational study to validate a blood-based test for the early detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.

Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early. The purpose of this prospective multi-center observational study is to validate a blood-based test for the detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.

Blood specimens will be de-identified and used to validate the performance characteristics of the Freenome test.

Prevention of Colorectal Cancer Through Multiomics Blood Testing

Freenome Holdings Inc.

Patients referred to St. Paul's Hospital for endoscopic management of a large (≥20mm) non-pedunculated colorectal polyp (LNPCP).

Endoscopic resection techniques for removal of large polyps

Endoscopic tissue resection

Shirley X Jiang, MD

Shirley X Jiang

Cherry Galorport

The SPARC-C study is a prospective, single-centre observational study of patients referred for the management of large (≥ 20mm) non-pedunculated colorectal polyps (LNPCPs). Patients are managed consistent with current standards of care. Prospectively collected data includes: patient clinicodemographic details, lesion details, procedural details, and clinical outcomes.

Endoscopic resection techniques, including endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), and cold snare resection (CSR), have become the primary treatment strategy for the vast majority of large non-pedunculated colorectal polyps (LNPCPs). This is because of the efficacy, safety, and cost-effectiveness of endoscopic techniques compared to surgery. Site-specific technical modifications and the development of auxiliary techniques/strategies have mitigated the risk of technical failure, clinically significant post-resection bleeding (CSPEB), significant deep mural injury (S-DMI)/perforation, and recurrence. However, questions still remain about the application and selection of these techniques.

This is a single-centre cohort study of consecutive patients referred for the management of LNPCPs to one of two interventional endoscopists with a tertiary referral practice in minimally invasive endoscopic resection techniques. It is based at St. Paul's Hospital and its affiliated sites, with the aim of enrolling 3500 participants over 10 years.

This cohort serves as a platform to continue refining the management of LNPCPs. We will evaluate LNPCP management outcomes, including technical success, clinical success, clinically significant intra-procedural bleeding (CSIPB), S-DMI, CSPEB, delayed perforation, recurrence, and referral to surgery. Findings will also help to further refine mitigating strategies for intra-procedural and post-procedural adverse outcomes (CSPIB, S-DMI, CSPEB, delayed perforation, recurrence, and referral to surgery). Finally, we aim to optimize the application of minimally invasive endoscopic resection techniques for the management of LNPCPs, including the development of artificial intelligence clinical decision support solutions (AI-CDSS).

St. Paul's Advanced Resection Center Cohort for Colorectal Neoplasia (SPARC-C)

The St. Paul's Hospital Advanced Endoscopic Resection Centre Cohort for Colorectal Neoplasia (SPARC-C): A Prospective Observational Study

Complete removal of all visible polypoid tissue during index procedure.

Technical success and the avoidance of surgery for large non-pedunculated colorectal polyps (LNPCPs) referred for endoscopic resection, assessed at first surveillance colonoscopy. LNPCPs with features consistent with invasive disease and directly referred for surgery are excluded.

Frequency and management of peri-procedural adverse outcomes including clinically significant intra-procedural bleeding, significant deep mural injury, clinically significant post-resection bleeding, delayed perforation, recurrence, and referral to surgery.

University of British Columbia

Assistant Professor of Medicine

The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.

The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.

The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.

Computer-Assisted Detection (CADe) Device

Scooter Plowman, MD

This is a prospective, multicenter, randomized controlled study to evaluate the effect of the Computer-Assisted Detection (CADe) Device on Adenomas Per Colonoscopy and Positive Percent Agreement for routine colonoscopies. The control arm is colonoscopy performed with High Definition White Light Endoscopy (HD-WLE) per standard of care. The intervention arm is colonoscopy performed with HD-WLE per standard of care plus the Computer-Assisted Detection (CADe) Device.

Subjects, investigators, study site personnel, and pathologists will not be blinded to treatment assignments. All Verily personnel involved in the statistical analysis of this study will be blinded to treatment assignment. For the interim analysis, unblinded analysis will be performed by an independent statistician, the results of which will be communicated to a select group of Verily personnel not involved in the study management.

Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)

Difference in Adenomas Per Colonoscopy (APC) between the control and intervention arm, evaluated for superiority. APC is defined as the average number of histologically confirmed adenomas resected per colonoscopy.

Difference in Positive Percent Agreement (PPA) between the control and intervention arm, evaluated for non-inferiority. PPA is defined as the total number of histologically confirmed Clinically Significant Excised Lesions, divided by the total number of excisions.

The Adenoma Detection Rate is defined as the number of patients with at least one histologically confirmed adenoma divided by the total number of patients enrolled per study arm.

A false alert is defined as a bounding box that persists on the screen (approximately 2-3 seconds per the judgment of the colonoscopist) that is then determined by the colonoscopist not to contain a polyp. The false alert rate is calculated as the number of false alerts per procedure conducted in the intervention arm of the study.

The withdrawal time is defined as the time measured from the moment the withdrawal phase of the procedure begins (with the scope in the cecum) to the moment the scope is withdrawn from the patient. The Inspection time measurement will exclude washing and resection, and other peri-resection activity not deemed to be colonic inspection. Inspection times for both the control arm and intervention arm will be calculated retrospectively upon review of the video recordings.

Polyp detection rate is defined as the proportion of patients with at least one histologically-confirmed polyp detected.

pADR is defined as the proportion of patients with at least one histologically-confirmed adenoma detected in proximal colon.

fADR is defined as the proportion of patients with at least one histologically-confirmed non-polypoid adenoma detected.

SLPC is defined as the number of histologically confirmed serrated lesions detected, divided by the total number of colonoscopies.

SLDR is defined as the proportion of patients with at least one histologically confirmed serrated lesion detected.

ADR\* is defined as ADR, but also includes histologically-confirmed intramucosal carcinoma and adenocarcinoma.

sADR is defined as proportion of patients with at least one adenoma 5mm or smaller detected.

PPC is defined as the total number of histologically-confirmed polyps found divided by the total number of colonoscopies performed, per study arm.

aADR is defined as the proportion of patients with at least one adenoma ≥ 10 mm, or any adenoma \< 10 mm, which was either of high-grade dysplasia (HGD) or villous or tubulovillous.

FPR is defined as the proportion of colorectal lesions resected or biopsied and subsequently not histologically-confirmed to be clinically relevant colorectal polyps (e.g. a pathology finding of normal mucosa, inflammatory tissue, stool or debris, lymphoid aggregates).

Verily Life Sciences LLC

Adenocarcinoma

Herbal and Botanical

All Drugs and Chemicals

Cola

Patients with neoplastic lesions less than 30mm unresectable en bloc by other less invasive endoscopic techniques, including lesions suggestive of T1 colorectal cancer, subepithelial tumors, lesions with diverticular involvement, lesions with no-lifting sign (recurrent, incomplete prior resection or untreated lesions).

Endoscopic full-thickness resection (EFTR) with Over-The-Scope-Clip in colorectal lesions

Endoscopic full-thickness resection

Hugo I. Uchima Koecklin, MD

Magin Farré Albadalejo

Javier Sola Vera

Ignasi Puig del Castillo

Alejandro Fernández

Alfredo Mata Bilbao

David Barquero

Jorge Carlos Espinós

Fernando Sábado

Francisco Martín

Eduardo Albéniz

Maria Pellisé

Joaquín Rodríguez Sánchez

Javier García Lledó

José Miguel Esteban

José Carlos Marín Gabriel

Pedro De María Pallarés

Pedro J. Rosón

Miguel Fraile López

Endoscopic full-thickness resection (EFTR) in the colon using an over-the-scope clip (OTSC) as a closure mechanism is a recent technique that allows the endoscopic resection of colonic lesions that are poor candidates for conventional endoscopic resection techniques. The aim is to study the safety and efficacy of EFTR in colon.

Early detection and endoscopic resection of early neoplastic lesions in colon can prevent the development of colon cancer.

The classic endoscopic mucosal resection technique and the submucosal dissection technique require the creation of a submucosal "cushion" by injecting crystalloid substances or colloids. However, these advanced techniques have technical limitations when facing a lesion that presents poor lifting or non-lifting at all as it might be observed in scarring or fibrotic lesions

Endoscopic full-thickness resection (EFTR) in the colon using an over-the-scope clip (OTSC) is a recent technique that does not require the injection of a submucosal solution and allows a resection of colonic lesions of up to approximately 30 mm, en bloc, allowing a correct histological study of the sample, to confirm its complete resection with adequate deep margins, evaluation of the level of invasion and lymphovascular involvement.

EFTR with OTSC allows a colonic wall full-thickness resection, by the deployment of an over-the-scope clip before the resection of the lesion to prevent perforation. The steps of the technique are: face the lesion and marking the borders, insertion of the scope with the kit (consisting of a cap with an integrated snare and OTSC), grasping and pulling the lesion into the cap, deploy the over-the-scope-clip (OTSC) and closing the integrated snare and resect.

This is a multicenter observational study on the efficacy and safety of EFTR with OTSC in colon.

The clinical, endoscopic and histological data are collected prospectively in all cases of EFTR performed in the participant centers.

Endoscopic Full-Thickness Resection In Colon

Multicenter Prospective Study of Endoscopic Full-thickness Resection (EFTR) in Colon Using Over-the-scope-clip (OTSC)

Percentage of complete en-bloc resection of the lesion without macroscopic residual tissue after completing the endoscopic full-thickness resection

Percentage of procedure-associated major adverse events: bleeding and/or perforation

Histologically confirmed full-thickness resection

Spanish Society of Digestive Endoscopy

Hospital de Sant Joan Despí Moisès Broggi

Complejo Hospitalario de Navarra

Hospital Clínico Universitario de Santiago de Compostela

Hospital Provincial de Castellon

Althaia Xarxa Assistencial Universitària de Manresa

Hospital Mutua de Terrassa

Hospital General Universitario Gregorio Marañon

Hospital San Carlos, Madrid

Hospital Universitario 12 de Octubre

Hospital General de Ciudad Real

Hospital General Universitario Elche

Hospital Universitario Central de Asturias

Hospital Clinic of Barcelona

Quironsalud

Hospital Universitario La Paz

Centro Medico Teknon

Germans Trias i Pujol Hospital

Fundació Institut Germans Trias i Pujol

Medical Specialist (gastroenterologist, MD)

Colonic Diseases, Functional

Adults 45 years of age and older who are at average risk of developing colorectal cancer and eligible for a screening colonoscopy

The Next-Gen CRC Screening Test is a blood-based screening test for detection of CRC.

Next-Gen CRC Screening Test

The CRC DRAW study will assess the sensitivity and specificity of the blood-based, Next-Gen CRC Screening Test for the detection of CRC.

The CRC DRAW study is a prospective, multi-center, observational study to validate the Next-Gen CRC Screening test for the detection of CRC. The study will collect blood samples from average-risk participants scheduled for screening colonoscopies.

Blood specimens will be de-identified and used to validate the performance characteristics of the Next-Gen CRC Screening Test. Blood samples may also be used for future research and development, feasibility and validation.

CRC Detection Reliable Assessment With Blood

Prospective, Multi-center Observational Study for the Clinical Validation of the Next Generation Test for Blood-based Screening of Colorectal Cancer

Epigenomics, Inc

Intestinal Polyps

Experimental arm : patients receive a colonoscopy using GI Genius™ intelligent endoscopy system (Medtronic Inc., Minneapolis, Minnesota, USA)

Control arm :The artificial intelligence is not activated during the colonoscopy exam,the patient receive a standard high definition colonoscopy

Colonoscopy

The aim of the study is to assess whether the use of artificial intelligence improves polyp detection in a segment of the colon (the right colon).

To achieve this objective, patients will be divided into two groups: one will undergo a standard colonoscopy, the other a colonoscopy with the artificial intelligence software connected to the machine.

This software does not modify the colonoscopy technique in any way, and does not require the administration of any product to the patient.

The study will compare the detection rate of right colon polyps between the group of patients who underwent standard colonoscopy and those who underwent colonoscopy with artificial intelligence. If this number does not differ between the two groups, the investigators can conclude that there is no point in using artificial intelligence.

Colorectal cancer (CRC) is the third most common cancer and remains one of the leading causes of mortality among neoplastic diseases in the world. Screening colonoscopy with detection and resection of colorectal polyps have reduced CRC incidence and mortality.

Nevertheless, colonoscopy is an imperfect screening test and its effectiveness is influenced by a range of variables including the skill and expertise of the endoscopist. Indeed, a significant proportion of colorectal neoplasia is missed during colonoscopic examinations. In the majority of studies, the rate of interval CRC among all CRCs ranged from 2% to 9% and interval cancers occurred more likely in the right colon. Interval cancers can result from missed lesion, incomplete removal or newly developed cancer. Most missed polyps are smaller than 10 mm in diameter and are sessile or flat in appearance. Therefore, sessile serrated adenomas (SSAs), which predominantly occur in the right colon, are easily missed because they are small and sessile.

Colonoscopy is less effective in screening right sided CRCs, mainly because of the increased miss rate for polyps with sessile or flat appearance. In recent years, artificial intelligence (AI) is increasingly applied in gastrointestinal endoscopy, especially in the detection of colorectal polyps. In 2019, the first prospective randomized controlled trial including 1058 patients and comparing the polyp detection rate in colonoscopy with or without AI showed a significantly higher detection rate in the group with AI (29.1% vs 20.3%). Other previous prospective studies have showed that AI had great potential for improving colonic polyp detection.

To our knowledge, this is the first study to date to evaluate the performance of the AI in the detection of right colon polyps.

In this study, the investigators aim first of all to compare the rate of right colon polyp detection with AI-aided colonoscopy (AIC) to the rate obtained by the Standard (high-definition) colonoscopy (SC) in patient undergoing diagnostic colonoscopy. Then, the investigators would to evaluate the following endpoints:

1. Comparison of time required for AIC versus SC (withdrawal time)
2. Comparison of histological classification of all polyps detected in each group
3. Comparison of the number of right colon polyps detected in each group
4. A subgroup analysis comparing the rate of colon polyp detection between the two groups will be realized according to the procedure starting time (accounting for operator fatigability).

Patients will be randomized into the two groups:

* Experimental : AI-aided colonoscopy using GI Genius™ intelligent endoscopy system (Medtronic Inc., Minneapolis, Minnesota, USA)
* Control : Standard high-definition colonoscopy:

Randomization will be established according to a 1:1 ratio, balanced and per block of variable size, and stratified according to age (≤50 vs \>50 years-old) and on personal polyps or colorectal cancer history (yes vs no)

A single-blind, randomised study. Patient is not informed of the arm he is assigned to.

Performance of Artificial Intelligence in Colonoscopy for Right Colon Polyp Detection

Performance of Artificial Intelligence in Colonoscopy for Right Colon Polyp Detection: a Randomized Controlled Trial

A multiple logistic regression comparing the percentage of patients with at least one right colon polyp detected according to the randomization group, and adjusted for Boston Bowel preparation scale (6-7 vs \>7), for the operator, for the endoscope (Pentax or Fuji) and for stratification factors (age and polyps or CRC history).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prevention of Colorectal Cancer Through Multiomics Blood Testing	NCT04369053	Colon Cancer Rectal Cancer Colon Neoplasm Colon Diseases Colon Lesion Colon Polyp Colorectal Canc... Polyp Adenoma Rectal Diseases Gastrointestina...	Freenome test	45 Years - 85 Years	Freenome Holdings Inc.
St. Paul's Advanced Resection Center Cohort for Colorectal Neoplasia (SPARC-C)	NCT05402696	Colon Adenoma Colon Polyp Colon Lesion	Endoscopic tiss...	18 Years -	University of British Columbia
Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)	NCT05275556	Colon Adenoma Colon Polyp Colon Lesion	Computer-Assist...	45 Years - 80 Years	Verily Life Sciences LLC
Endoscopic Full-Thickness Resection In Colon	NCT03803891	Colon Neoplasm,... Colo-rectal Can... Colonic Cancer Colonic Adenoma Colorectal Canc... Colorectal Neop... Colorectal Aden... Colon Polyp Colon Lesion Colon Neoplasm	Endoscopic full...	18 Years -	Fundació Institut Germans Trias i Pujol
CRC Detection Reliable Assessment With Blood	NCT05551052	Colorectal Canc... Adenomas Colon Colon Cancer Rectal Cancer Colon Neoplasm Colon Lesion Colon Disease Colon Polyp Polyps Adenoma Rectal Diseases Rectal Polyp Gastrointestina... Intestinal Neop... Colonic Disease... Intestinal Dise...	Next-Gen CRC Sc...	45 Years -	Epigenomics, Inc
St. Paul's Advanced Resection Center Cohort for Colorectal Neoplasia (SPARC-C)	NCT05402696	Colon Adenoma Colon Polyp Colon Lesion	Endoscopic tiss...	18 Years -	University of British Columbia
Performance of Artificial Intelligence in Colonoscopy for Right Colon Polyp Detection	NCT06216405	Colon Cancer Colon Polyp Colon Lesion Colon Adenocarc...	Colonoscopy	18 Years -	Groupe Hospitalier Diaconesses Croix Saint-Simon

Spots Global Cancer Trial Database for colon lesion

Every month we try and update this database with for colon lesion cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.