Evaluation of ArTificial Intelligence System (Gi-Genius) for adenoMa dEtection in Lynch Syndrome.

Related Clinical Trial
Prostate Cancer Genetic Risk Evaluation and Screening Study Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients Overcoming Barriers to the Uptake of Cascade Screening for Lynch Syndrome: Workbook Feasibility Study Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome Evaluation of ArTificial Intelligence System (Gi-Genius) for adenoMa dEtection in Lynch Syndrome. DNA Adductomics for Colorectal Cancer Investigation PD-1 Antibody Following Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Faecal Microbiota Characterization in Lynch Syndrome (LS) Patients With or Without Colorectal Neoplasia Evaluating the Cologuard Test for Use in Lynch Syndrome PD-1 Antibody for The Prevention of Adenomatous Polyps and Second Primary Tumors in Lynch Syndrome Patients Lynch Syndrome Can be Diagnosed Just From Somatic Mismatch Repair Mutation Implementation of the Families Accelerating Cascade Testing Toolkit (FACTT) for Hereditary Breast and Ovarian Cancer and Lynch Syndrome Identifying and Caring for Individuals With Inherited Cancer Syndrome Predictive Factor Study of the Occurrence of Endometrial Cancer in Patients With Lynch Syndrome Liquid Biopsy Evaluation and Repository Development at Princess Margaret Direct Information to At-risk Relatives Family History Study on Cancer Risk Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer Biomarkers in Samples From Patients With Endometrial Cancer Genetic Risk: Whether, When, and How to Tell Adolescents Familial Colorectal Cancer Registry in Hispanics Prostate Cancer Screening Among Men With High Risk Genetic Predisposition Collecting Information From Patients and Family Members With Hereditary Colorectal Cancer Syndromes or Who Are at High Risk of Developing Colorectal Cancer Identifying Patients With Hereditary and Familial Colorectal Cancer by Using an Online Risk Tool Pediatric Reporting of Adult-Onset Genomic Results Trial to Compare eConsent With Standard Consent Among Prospective Biobank Participants MSI in Circulatory DNA of Endometrial Cancer Telemedicine vs. Face-to-Face Cancer Genetic Counseling Educational CD-ROM Compared With Standard Informed Consent for Patients With Colorectal Cancer or a Family History of Colorectal Cancer Implementation of a New Strategy to Identify HNPCC Patients Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members Preliminary Evaluation of Septin9 in Patients With Hereditary Colon Cancer Syndromes The GEOLynch Cohort Study Universal Endometrial Cancer DNA Sequencing for Detection of Lynch Syndrome and Personalized Care Weight Management and Health Behavior Intervention in Lowering Cancer Risk for BRCA Positive and Lynch Syndrome Families Naproxen in Preventing DNA Mismatch Repair Deficient Colorectal Cancer in Patients With Lynch Syndrome Cascade Genetic Testing for Hereditary Breast/Ovarian Cancer and Lynch Syndrome in Switzerland Omega 3 Fatty Acids in Colorectal Cancer (CRC) Prevention in Patients With Lynch Syndrome (COLYNE) NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome I-Scan For Colon Polyp Detection In HNPCC Metagenomic Evaluation of the Gut Microbiome in Patients With Lynch Syndrome and Other Hereditary Colonic Polyposis Syndromes Psychosocial Aspects of Genetic Testing for Hereditary Nonpolyposis Colon Cancer Ohio Colorectal Cancer Prevention Initiative Nivolumab in Preventing Colon Adenomas in Participants With Lynch Syndrome and a History of Partial Colectomy Molecular Screening for Lynch Syndrome in Denmark Atorvastatin ± Aspirin in Lynch Syndrome Syndrome Diagnosis of Lynch Syndrome Based on Next-generation Sequencing in Colorectal Cancer Uncertain Genetic Test Results for Lynch Syndrome High Definition White-Light Colonoscopy vs. Chromoendoscopy for Surveillance of Lynch Syndrome. Linked Color Imaging Versus High-definition White Light Endoscopy for the Detection of Polyps in Patients With Lynch Syndrome (LCI-LYNCH) Hereditary Nonpolyposis Colorectal Cancer in Taiwan-Related Genetic Study and Clinical Applications Molecular Screening for Lynch Syndrome in Southern Denmark Universal Screening for Lynch Syndrome in Women With Endometrial and Non-Serous Ovarian Cancer Multi-Organ Screening Recommendations in Patients With Lynch Syndrome Diagnosis of Lynch Syndrome Based on Next-generation Sequencing in Patients Meeting Chinese Lynch Syndrome Criteria Chromoendoscopy to Decrease the Risk of Colorectal Neoplasia in Lynch Syndrome Effect of Chemoprevention by Low-dose Aspirin of New or Recurrent Colorectal Adenomas in Patients With Lynch Syndrome Integrating Genetic Testing for Lynch Syndrome in a Managed Care Setting Registry for Women Who Are At Risk Or May Have Lynch Syndrome

Brief Title

Evaluation of ArTificial Intelligence System (Gi-Genius) for adenoMa dEtection in Lynch Syndrome.

Official Title

Evaluation of ArTificial Intelligence System (Gi-Genius) for adenoMa dEtection in Lynch Syndrome. A Randomized, Parallel, Multicenter, Controlled Trial. TIMELY Study.

Brief Summary

      The purpose of this study is to assess if artificial intelligence aid colonoscopy colonoscopy
      is superior to conventional colonoscopy for the detection of adenomas during surveillance
      colonoscopy in patients with Lynch syndrome.
    

Detailed Description

      To compare the performance of white-light colonoscopy (HD-WLE) versus white-light + CAD (CAD)
      for detection of adenomas (1:1 ratio). The CAD system will include an artificial
      intelligence-based medical device (GI Genius, Medtronic) trained to process colonoscopy
      images and superimpose them, in real time, on the endoscopy display as a green box over
      suspected lesion. An adequate bowel preparation and minimum withdrawal time of 6 min will be
      required. Colonoscopies will be performed by experienced endoscopists and with
      high-definition scopes. Lesions will be collected, and histopathology findings used as the
      reference standard. The primary outcome of this trial will be the mean number of adenomas per
      colonoscopy (APC).
    


Study Type

Interventional


Primary Outcome

Mean number of adenomas per colonoscopy

Secondary Outcome

 Withdrawal time

Condition

Lynch Syndrome

Intervention

Gi Genius, Medtronic

Study Arms / Comparison Groups

 CAD arm
Description:  Patients allocated to CAD arm will receive during colonoscopy withdrawal high definition white light endoscopy aided with artificial intelligence device (Gi Genius, Medtronic)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

404

Start Date

February 1, 2022

Completion Date

December 1, 2023

Primary Completion Date

December 1, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥18 years with a proven pathogenic germline variant in one of the MMR genes (MLH1,
             MSH2, MSH6) or Epcam deletion who are under surveillance colonoscopy.

        Exclusion Criteria:

          -  Previous history of total colectomy,

          -  Concomitant inflammatory bowel disease,

          -  Inability or refuse to sign the informed consent,

          -  Previous colonoscopy < 12 months.

          -  Inadequate bowel preparation.

          -  Incomplete procedure.

          -  PMS2 mutation carriers
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, +34 932275400, [email protected]

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT04909671

Organization ID

Timely


Responsible Party

Principal Investigator

Study Sponsor

Hospital Clinic of Barcelona

Collaborators

 European Society of Gastrointestinal Endoscopy

Study Sponsor

, , 


Verification Date

January 2022