Precancerous conditions and carcinomas of the upper gastrointestinal tract (in particular, but not exclusively: intestinal metaplasia, atrophic gastritis, Helicobacter pylori infection, Barrett epithelium, dysplasia, carcinomas)
Conditions
Interventions
Group 1: 1. High risk score 1 (RS1) leads to inclusion in the main study: epidemiological data collection, sampling of biomarkers and esophagogastroduodenoscopy (EGD)
2. Additional study: Collection
Sponsors
Lehrstuhl für Epidemiologie der Universität Augsburg am Universitätsklinikum Augsburg
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: - People from the general population: participants in organised colorectal cancer screening, patients in general practices, patients in gastroenterological practices who would not undergo an EGD for medical reasons. - Signed informed consent form - Presence of a high RS1
Exclusion criteria
Exclusion criteria: - Subjects unable to give consent - Presence of a non-high RS1 - Age 75 years - EGD within the past 3 years - Diseases that warrant an endoscopic examination or follow-up of the upper gastrointestinal tract - Known, active or past tumour diseases of the upper GIT - Presence of polyposis or Lynch syndrome - Acute GI haemorrhage (varicose or non-varicose) in the upper GIT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of the validation study is to prove that a preventive EGD with an appropriate risk profile (determined using RS1 and subsequently determined RS2) is effective and acceptable, so that many premalignant/malignant changes in the upper digestive tract can be diagnosed at an early stage and thus treated well, thereby significantly improving the prognosis of patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Development of an AI algorithm for analysing the quality and detection of precancerous lesions in OGD procedures using video recordings. 2. Analysis of stored biosamples of biomarkers necessary for the calculation of RS2 to validate RS2 3. Additional study to test the sensitivity of RS1 using data from routine patients with EGDs. The aim is to determine the number of patients with non-high RS1 but positive findings (with regard to premalignant/malignant lesions) in the EGD. | — |
Countries
Germany
Contacts
Public ContactJakob Linseisen
Lehrstuhl für Epidemiologie der Universität Augsburg am Universitätsklinikum Augsburg
Outcome results
None listed