Lynch Syndrome
Conditions
Interventions
Group 1: Prospective observation of Lynch syndrome patients who receive endoscopic screening of the upper gastrointestinal tract by means of OGD (oesophagogastroduodenoscopy) based on national recomme
Sponsors
Nationales Zentrum für erbliche Tumorerkrankungen, Universitätsklinikum Bonn
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Signed informed consent - Patient must be able to follow study instructions and expected to attend and complete all required study visits. - Confirmed diagnosis of a (likely-) pathogenic germline variant in MLH1, MHS2, MSH6, PMS2 or EPCAM (Lynch Syndrome)
Exclusion criteria
Exclusion criteria: - Subjects without legal capacity who are unable to understand the nature, scope, significance and consequences of this clinical trial - Patients with a physical or mental condition that, in the judgment of the investigator, could pose a risk to the patient, confound the study results, or interfere with participation in the clinical study - Personal history of duodenal or gastric surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative 10-year incidence of neoplasia in the upper GI tract (esophageal, gastric, duodenal and jejunum carcinomas) in patients with Lynch syndrome. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Total number, size and histopathology (tubular/villous/tubulovillous and grade of dysplasia) of gastric/duodenal/jejunal adenomas - 10-year cumulative incidence of gastric, duodenal or jejunal adenomas - 10-year incidence of autoimmune gastritis and subsequently intestinal metaplasia (+/- dysplasia) - 10-year incidence of Barrett’s metaplasia +/-dysplasia - Gastric/duodenal/jejunal cancer stage - Gastric/duodenal/jejunal cancer-related mortality - Costs of intervention/non-intervention - 10-year cumulative incidence of (pre-) neoplastic lesions of the upper GI tract in regard of different pathogenic variants (MLH1, MSH2, MSH6, PMS2, EPCAM) - 10-year cumulative incidence of (pre-) neoplastic lesions of the upper GI tract in patients with and without positive family history (1st or 2nd degree relatives) - synchronous occurrence of upper GI (pre-)neoplastic lesions and other synchronous cancers (defined as 6 months prior or post documentation of cancer) - observation period: 01.09.2024- 31.08.2034. - Examination and patient data obtained through regular patient care will be collected. No additional study visits or interventions are planned | — |
Countries
Denmark, Germany, Italy, Singapore, United Kingdom, United States
Contacts
Public ContactRobert Hüneburg
Nationales Zentrum für erbliche Tumorerkrankungen, Universitätsklinikum Bonn
Outcome results
None listed