Clinical trial NCT04909671: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lynch Syndrome
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: European Society of Gastrointestinal Endoscopy
First posted: 2021-06-02
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

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

Primary outcomes:
measure: Mean number of adenomas per colonoscopy
timeFrame: 18 months
Secondary outcomes:
measure: Withdrawal time
timeFrame: 18 months
measure: Mean number of polyps per colonoscopy
timeFrame: 18 months
measure: Adenoma detection rate
timeFrame: 18 months
measure: Polyp detection rate
timeFrame: 18 months
measure: False positives in CAD arm
timeFrame: 18 months
measure: Mean number of non-clinically significant removed lesions
timeFrame: 18 months
measure: Subjective endoscopist measures
timeFrame: 18 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: María Pellisé. MD. PhD.
city: Barcelona
country: Spain
facility: Oswaldo ortiz
Study officials:
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