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NCT06275997Not yet recruiting

GAIN Project: Gastric Cancer and Artificial Intelligence

Gastric Cancer and Artificial Intelligence: a National-level Project

Source: ClinicalTrials.gov · Last updated 4 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Our GAIN project comprises four core work packages (WPs): WP1. Nation-level randomized controlled trial; WP2. Development of an innovative AI tool; WP3. Novel microsimulation modelling; WP4. Patient inclusion. The nation-level multi-center tandem randomized controlled trial (WP1) will contribute to a better understanding of how the real-time AI algorithm can reduce miss rate of early gastric cancer and dysplasia during gastroscopy. Moreover, the innovation project will contribute to development of a novel AI tool (WP2) that can stratify the risk of gastric cancer by identifying in vivo precancerous conditions. Furthermore, a microsimulation modelling will allow us to predict how the use of AI can prevent gastric cancer and affect cost and patients' burdens. The assessment of the balance between benefits and harms is quite crucial especially for this type of medical device because the value of innovative tools is sometimes overestimated due to stakeholders' enthusiasm (WP3). Finally, we will take care of patients' perspective throughout the study project by including patient organization in both WP1, 2, and 3 (WP4).

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
6600 (estimated)
First submitted
2 Feb 2024
Start date
10 Jun 2024
Primary completion date
Jun 2026
Lead sponsor
Istituto Clinico Humanitas
NCT number
NCT06275997

What you commit to

  • Study type: Interventional
  • Planned participants: 6600
  • From 10 Jun 2024 to the primary completion date, Jun 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • patients with previous upper-GI surgery involving the stomach.

Other illness

  • active upper-GI bleeding or urgent upper-GI endoscopy.

Other

  • contraindications to upper-GI endoscopy.
  • contraindications to biopsy.
  • patients who were not able or refused to give informed written consent.

Who the study is looking for

  • All \>60 years-old patients undergoing upper-gastrointestinal (GI) endoscopy for selected indications in Italian areas at high-risk of gastric cancer (Lombardia, Emilia Romagna, Veneto, Friuli-Venezia Giulia).

Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.