The Early Registry
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Study Overview
Study Title: Evaluation of Upper Gastrointestinal Tract Surveillance in Individuals with Lynch Syndrome (EARLY)
DRKS-ID: DRKS00031932
Trial Short Title: EARLY
Trial Population:
This study includes male and female patients with a confirmed (likely-) pathogenic germline variant in MLH1, MHS2, MSH6, PMS2, or EPCAM.
Study Design:
- Multicenter, prospective, non-intervention, open cohort, registry
Endpoints:
- Primary Endpoint: 10-year cumulative incidence of upper GI tract neoplasms
- Secondary Endpoints: detailed analysis of adenomas, autoimmune gastritis, cancer stages, mortality rates, and synchronous cancers.
Participation
Subject Number:
The study expects to screen around 10,000 patients, with approximately 5,000 assigned to the trial and 4,000 analyzed upon completion.
Inclusion Criteria:
- Age 18 or older
- Signed informed consent
- Confirmed diagnosis of a pathogenic germline variant in MLH1, MHS2, MSH6, PMS2, or EPCAM
Exclusion Criteria:
- Lack of legal capacity to understand the trial
- History of duodenal or gastric surgery.
Study Steps:
- Screening: Obtain informed consent from participants and verify eligibility based on inclusion/exclusion criteria
- Follow-Up: Collect comprehensive health data, including medical history, family history, results from upper endoscopies (EGDs), and relevant medication records.
Time Schedule:
- Planned Start Date: September 1, 2024
- Planned End Date: August 31, 2034
For more information about the EARLY study, please contact:
National Center for Hereditary Tumor Diseases (NZeT)
University Hospital Bonn
Venusberg-Campus 1, 53127 Bonn
Email: nzet@ukbonn.de