Early detection of gastric cancer and its precursor conditions by endoscopic screening
- Conditions
- gastric cancerstomach cancer1001799010017991
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 400
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Patients without any known gastric condition who will undergo a colonoscopy
after positive FIT screening or require a colonoscopy as part of polyp
surveillance;
• Age 50-74;
• Able to undergo a gastroscopy;
• Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the informed consent form (ICF) and in
this protocol.
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Previous esophageal or gastric surgery such as gastric bypass or
esophagectomy.
• Patients with known GA/GIM, gastric cancer or treated in the past for gastric
dysplasia with endoscopic therapy
• Patients with genetic cancer syndromes
• Acute upper GI bleeding within the last 4 weeks
• Patients with coagulation disorders leading to increased bleeding risk
• Pregnancy, breast-feeding women
• Patients with an insurmountable language barrier due to which it is
impossible to perform correct and complete information about the purposes of
the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of the current protocol is to determine the diagnostic<br /><br>yield (in percentage of detected conditions)of an upper endoscopy to detect<br /><br>(pre)malignant gastric lesions in patients who will require a colonoscopy.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• The extra value of endoscopy to serology screening among other approaches.<br /><br>• The prevalence of other upper gastrointestinal conditions in the study<br /><br>population.<br /><br>• The endoscopist*s performance to detect relevant gastric lesions, as well as<br /><br>oesophageal or duodenal conditions.<br /><br>• Safety of the procedure and the participants* satisfaction, including also<br /><br>reasons not to participate.<br /><br>• The diagnostic value of a positive FIT in detecting upper gastrointestinal<br /><br>lesions.</p><br>