Studie zur Vorbeugung von
Darmpolypen mit Grüntee-Extrakt

Data collection and management

Data collection

Information on each patient's age, gender, height, weight, waist-to-hip ratio, ethnicity, regular tea intake, sport and activity level, smoking state, alcohol intake, family history of colon cancer and current disease and medication will be obtained from the initial interview before the run-in phase. From the colonoscopy prior to study entry, data on the number, localization and size of the removed adenoma(s) as well as the histological subtype and history of prior colonoscopies will be assessed. The patients' attitudes towards medicine and herbal supplements will be assessed at the beginning of the study.

At the follow-up visits, data on changes in concurrent disease or drug therapy, data on regular intake of the study medication and green tea beverages, laboratory data on liver enzymes and any adverse events experienced during the study will be recorded.

At the final visit, weight, waist-to-hip ratio, regular tea intake, data on changes in disease and medication will be obtained as well as data from the follow-up colonoscopy on the number, localization and size of the removed adenoma(s) as well as the histological subtype.

Data management

Data management, query management and monitoring of the study will be done by the Coordination Center for Clinical Trials at the Martin Luther University of Halle-Wittenberg (KKSH). Data collection will be done on paper CRFs and will be entered and stored in a validated GCP conform database. Study monitoring will be performed with one on-site visit per study center and regular data-entry checks of the CRFs.

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