Studie zur Vorbeugung von
Darmpolypen mit Grüntee-Extrakt

Study outcomes

Primary outcome

The primary outcome parameter will be the incidence of any (n equal to or larger than 1) metachronous colorectal adenomas (tubulovillous, tubular, villous and serrated lesions) at the 3 year follow-up colonoscopy in both groups.

Secondary outcomes

The occurrences, number, localization, size and histological subtypes of adenomas or mucosal lesions and invasive growth, as well as the time to detection of new colorectal carcinoma (assuming that in several patients more than one colonoscopy will be performed within 3 years) and the frequency of carcinoma, will be assessed as secondary outcome parameters in both groups. In addition, genetic and biochemical biomarkers for the recurrence of adenoma or the development of dysplasia and carcinoma will be analyzed in the blood samples entered into the biobanking subproject. Paraffin-embedded tissue samples will be collected in participants who show a high grade dysplastic adenoma or serrated adenoma at the follow-up colonoscopy. In these samples, besides the histological analyses the possibly therapeutically relevant tumor-genetical alterations including K-ras mutation, B-raf mutation or specific microRNA will be analyzed.

In an independent project, the nutrikinetics and nutrigenetics of EGCG and other green tea catechins will be assessed in healthy volunteers with the capsules used in this study.

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