Gastric cancer, Intestinal metaplasia, Gastric Atrophy
Conditions
Interventions
Patients will be asked to undergo an additional gastroscopy during their
standard of care diagnostic endoscopy during which five biopsies will be taken.
In addition, a blood sample (9 ml) will be ta
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the current protocol is to determine the diagnostic yield (in percentage of detected conditions)of an upper endoscopy to detect (pre)malignant gastric lesions in patients who will require a colonoscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| • The extra value of endoscopy to serology screening among other approaches. • The prevalence of other upper gastrointestinal conditions in the study population. • The endoscopist*s performance to detect relevant gastric lesions, as well as oesophageal or duodenal conditions. • Safety of the procedure and the participants* satisfaction, including also reasons not to participate. • The diagnostic value of a positive FIT in detecting upper gastrointestinal lesions. | — |
Countries
France, Germany, Ireland, Lithuania, Netherlands, Portugal
Contacts
Public ContactV. Spaander
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed