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

Lynch Syndrome Clinical Trial

— Timely  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04909671
• Other study ID #: Timely
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2022
• Source: Hospital Clinic of Barcelona
• Contact: Maria Pellise, Phd
• Phone: +34 932275400
• Email: mpellise[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 404
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Lynch Syndrome
• Syndrome

Intervention

Device:
• Gi Genius, Medtronic
GI geniusTM (Medtronic) is an artificial intelligence device designed and validated on a dataset of white-light endoscopy videos from high-quality randomized controlled trials for the detection of colorectal lesions during colonoscopy. Based on a deep learning system using convolutional neural networks, GI genius works in real-time side-to-side with the gastroenterologist during colonoscopy highlighting the presence of precancerous lesions with a visual marker (green box) in real time and designed to be integrated with the majority of colonoscopies.

Other:
• White light standart colonoscopy
High definition white light endoscopy will be used during the scope withdrawal

Locations

Country	Name	City	State
Spain	María Pellisé. MD. PhD.	Barcelona
Spain	Oswaldo ortiz	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	European Society of Gastrointestinal Endoscopy

Country where clinical trial is conducted

Spain, 

References & Publications (22)

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Haraldsdottir S, Rafnar T, Frankel WL, Einarsdottir S, Sigurdsson A, Hampel H, Snaebjornsson P, Masson G, Weng D, Arngrimsson R, Kehr B, Yilmaz A, Haraldsson S, Sulem P, Stefansson T, Shields PG, Sigurdsson F, Bekaii-Saab T, Moller PH, Steinarsdottir M, Alexiusdottir K, Hitchins M, Pritchard CC, de la Chapelle A, Jonasson JG, Goldberg RM, Stefansson K. Comprehensive population-wide analysis of Lynch syndrome in Iceland reveals founder mutations in MSH6 and PMS2. Nat Commun. 2017 May 3;8:14755. doi: 10.1038/ncomms14755. — View Citation

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, Rösch 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. Review. — View Citation

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Hüneburg R, Lammert F, Rabe C, Rahner N, Kahl P, Büttner R, Propping P, Sauerbruch T, Lamberti C. Chromocolonoscopy detects more adenomas than white light colonoscopy or narrow band imaging colonoscopy in hereditary nonpolyposis colorectal cancer screening. Endoscopy. 2009 Apr;41(4):316-22. doi: 10.1055/s-0028-1119628. Epub 2009 Apr 1. — View Citation

IJspeert JE, Bastiaansen BA, van Leerdam ME, Meijer GA, van Eeden S, Sanduleanu S, Schoon EJ, Bisseling TM, Spaander MC, van Lelyveld N, Bargeman M, Wang J, Dekker E; Dutch Workgroup serrAted polypS & Polyposis (WASP). Development and validation of the WASP classification system for optical diagnosis of adenomas, hyperplastic polyps and sessile serrated adenomas/polyps. Gut. 2016 Jun;65(6):963-70. doi: 10.1136/gutjnl-2014-308411. Epub 2015 Mar 9. — View Citation

Järvinen HJ, Aarnio M, Mustonen H, Aktan-Collan K, Aaltonen LA, Peltomäki P, De La Chapelle A, Mecklin JP. Controlled 15-year trial on screening for colorectal cancer in families with hereditary nonpolyposis colorectal cancer. Gastroenterology. 2000 May;118(5):829-34. — View Citation

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. Endoscopy. 2017 Apr;49(4):378-397. doi: 10.1055/s-0043-103411. Epub 2017 Mar 7. — View Citation

Lynch HT, Snyder CL, Shaw TG, Heinen CD, Hitchins MP. Milestones of Lynch syndrome: 1895-2015. Nat Rev Cancer. 2015 Mar;15(3):181-94. doi: 10.1038/nrc3878. Epub 2015 Feb 12. Review. — View Citation

Nagtegaal ID, Odze RD, Klimstra D, Paradis V, Rugge M, Schirmacher P, Washington KM, Carneiro F, Cree IA; WHO Classification of Tumours Editorial Board. The 2019 WHO classification of tumours of the digestive system. Histopathology. 2020 Jan;76(2):182-188. doi: 10.1111/his.13975. Epub 2019 Nov 13. — View Citation

Rahmi G, Lecomte T, Malka D, Maniere T, Le Rhun M, Guimbaud R, Lapalus MG, Le Sidaner A, Moussata D, Caron O, Barbieux JP, Gaudric M, Coron E, Barange K, Ponchon T, Sautereau D, Samaha E, Saurin JC, Chaussade S, Laurent-Puig P, Chatellier G, Cellier C. Impact of chromoscopy on adenoma detection in patients with Lynch syndrome: a prospective, multicenter, blinded, tandem colonoscopy study. Am J Gastroenterol. 2015 Feb;110(2):288-98. doi: 10.1038/ajg.2014.423. Epub 2015 Jan 20. — View Citation

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. — View Citation

Rijcken FE, Hollema H, Kleibeuker JH. Proximal adenomas in hereditary non-polyposis colorectal cancer are prone to rapid malignant transformation. Gut. 2002 Mar;50(3):382-6. — View Citation

Rivero-Sánchez L, Arnau-Collell C, Herrero J, Remedios D, Cubiella J, García-Cougil M, Alvarez V, Albéniz E, Calvo P, Gordillo J, Puig I, López-Vicente J, Huerta A, López-Cerón M, Salces I, Peñas B, Parejo S, Rodriguez de Santiago E, Herraiz M, Carretero C, Gimeno-Garcia AZ, Saperas E, Alvarez-Urturi C, Moreira R, Rodriguez de Miguel C, Ocaña T, Moreira L, Carballal S, Sánchez A, Jung G, Castells A, Llach J, Balaguer F, Pellisé M; EndoCAR group from Spanish Gastroenterology Association (AEG) and Spanish Society of Digestive Endoscopy (SEED). White-Light Endoscopy Is Adequate for Lynch Syndrome Surveillance in a Randomized and Noninferiority Study. Gastroenterology. 2020 Mar;158(4):895-904.e1. doi: 10.1053/j.gastro.2019.09.003. Epub 2019 Sep 12. — View Citation

Rondagh EJ, Gulikers S, Gómez-García EB, Vanlingen Y, Detisch Y, Winkens B, Vasen HF, Masclee AA, Sanduleanu S. Nonpolypoid colorectal neoplasms: a challenge in endoscopic surveillance of patients with Lynch syndrome. Endoscopy. 2013;45(4):257-64. doi: 10.1055/s-0032-1326195. Epub 2013 Feb 25. — View Citation

Sánchez A, Roos VH, Navarro M, Pineda M, Caballol B, Moreno L, Carballal S, Rodríguez-Alonso L, Ramon Y Cajal T, Llort G, Piñol V, López-Fernández A, Salces I, Picó MD, Rivas L, Bujanda L, Garzon M, Pizarro A, Martinez de Castro E, López-Arias MJ, Poves C, Garau C, Rodriguez-Alcalde D, Herraiz M, Alvarez-Urrutia C, Dacal A, Carrillo-Palau M, Cid L, Ponce M, Barreiro-Alonso E, Saperas E, Aguirre E, Romero C, Bastiaansen B, Gonzalez-Acosta M, Morales-Romero B, Ocaña T, Rivero-Sánchez L, Jung G, Bessa X, Cubiella J, Jover R, Rodríguez-Moranta F, Balmaña J, Brunet J, Castells A, Dekker E, Capella G, Serra-Burriel M, Moreira L, Pellise M, Balaguer F. Quality of Colonoscopy Is Associated With Adenoma Detection and Postcolonoscopy Colorectal Cancer Prevention in Lynch Syndrome. Clin Gastroenterol Hepatol. 2022 Mar;20(3):611-621.e9. doi: 10.1016/j.cgh.2020.11.002. Epub 2020 Nov 3. — View Citation

Sano Y, Tanaka S, Kudo SE, Saito S, Matsuda T, Wada Y, Fujii T, Ikematsu H, Uraoka T, Kobayashi N, Nakamura H, Hotta K, Horimatsu T, Sakamoto N, Fu KI, Tsuruta O, Kawano H, Kashida H, Takeuchi Y, Machida H, Kusaka T, Yoshida N, Hirata I, Terai T, Yamano HO, Kaneko K, Nakajima T, Sakamoto T, Yamaguchi Y, Tamai N, Nakano N, Hayashi N, Oka S, Iwatate M, Ishikawa H, Murakami Y, Yoshida S, Saito Y. Narrow-band imaging (NBI) magnifying endoscopic classification of colorectal tumors proposed by the Japan NBI Expert Team. Dig Endosc. 2016 Jul;28(5):526-33. doi: 10.1111/den.12644. Epub 2016 Apr 20. Review. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean number of adenomas per colonoscopy	Compare mean number of adenomas in both arms calculated by dividing the total number of adenomas detected by the total number of colonoscopies in each arm	18 months
Secondary	Withdrawal time	time spent on inspection, from the cecum to endoscope extraction through the anus, excluding the time needed for therapeutic measures (including polypectomy).	18 months
Secondary	Mean number of polyps per colonoscopy	Compare mean number of polyps in both arms calculated by dividing the total number of polyps (including serrated lesions and adenomas) detected by the total number of colonoscopies in each arm	18 months
Secondary	Adenoma detection rate	proportion of individuals undergoing a complete colonoscopy who had at least one adenoma detected between two arms.	18 months
Secondary	Polyp detection rate	proportion of individuals undergoing a complete colonoscopy who had at least one polyp detected between two arms.	18 months
Secondary	False positives in CAD arm	Combination of: Lesions detected by CAD (>2s green box) after an adequate inspection with a high confidence optical diagnosis negative for neoplasia made by the endoscopist.; Lesions detected by CAD (>2s green box) after an adequate inspection resected by the endoscopist and with a clinically non-significant histology.	18 months
Secondary	Mean number of non-clinically significant removed lesions	Lesions removed and with a histology of normal or inflammatory mucosa or removed diminutive recto-sigmoid polyps with a histology of hyperplastic	18 months
Secondary	Subjective endoscopist measures	Questionary addresing the easiness and satisfaction of the procedure, detection of lesions and performance of artificial intelligence will be filled in by each endoscopist	18 months