Study protocol of the RaPS study: novel risk adapted prevention strategies for people with a family history of colorectal cancer

Kaja Tikk,Stefanie J. Klug,Ulrich Mansmann,Hermann Brenner,Jochen Hampe,Matthias Schwab,Michael Hoffmeister,Svitlana Igel,Frank Kolligs,Korbinian Weigl

doi:10.1186/s12885-018-4646-5

Abstract

BackgroundPeople aged 40–60 years with a family history (FH) of colorectal cancer (CRC) in 1st degree relatives (FDRs) have a 2- to 4-fold increased risk of CRC compared to the average risk population. Therefore, experts recommend starting CRC screening earlier for this high-risk group. However, information on prevalence of relevant colonoscopic findings in this group is sparse, and no risk adapted screening offers are implemented in the German health care system. For example, screening colonoscopy is uniformly offered from age 55 on, regardless of family history. Thus, we initiated a multicenter epidemiological study - the RaPS study (Risk adapted prevention strategies for colorectal cancer) – with the following aims: to determine the prevalence of having a FH of CRC in FDR in the German population aged 40–54 years; to investigate the prevalence of colorectal neoplasms among people with a FDR; and to develop risk-adapted prevention strategies for this high-risk group based on the collected information.Methods/DesignA random sample of 160.000 persons from the general population aged 40–54 years from the catchment areas of three study centers in Germany (Dresden, Munich and Stuttgart) are contacted to assess FH of CRC by an online-questionnaire. Those with a FH of CRC in FDRs are invited to the study centers for individual consultation regarding CRC prevention. Participants are asked to donate blood and stool samples and medical records of colonoscopies will be obtained. Prevalence of CRC and its precursors will be evaluated. Furthermore, genetic, epigenetic and proteomic biomarkers in blood and microbiomic biomarkers in stool will be investigated. Risk markers and their eligibility for risk adapted screening offers will be examined.DiscussionThis study will provide data on the prevalence of colorectal neoplasms among persons with a FH of CRC in the age group 40–54 years, which will enable us to derive evidence based screening strategies for this high-risk group.Trial registrationThis trial was registered retrospectively in the German Clinical Trials Register (DRKS) on 29th of December 2016: German Clinical Trials Register DRKS-ID: DRKS00007842.

Highlights

People aged 40–60 years with a family history (FH) of colorectal cancer (CRC) in 1st degree relatives (FDRs) have a 2- to 4-fold increased risk of CRC compared to the average risk population
It is well known that people with a family history (FH) of CRC are at increased risk of the disease [5] and guidelines commonly recommend that first degree relatives of CRC patients should undergo earlier and more intensive screening [6]
Data from large scale population-based studies on the prevalence of FH of CRC according to age, sex and other potential determinants, on the age and sex specific prevalence of colorectal neoplasms according to FH, on the use of CRC screening offers by those with a FH, and on the performance of potential noninvasive screening methods in this high risk group are sparse

Summary

Introduction

People aged 40–60 years with a family history (FH) of colorectal cancer (CRC) in 1st degree relatives (FDRs) have a 2- to 4-fold increased risk of CRC compared to the average risk population. We initiated a multicenter epidemiological study - the RaPS study (Risk adapted prevention strategies for colorectal cancer) – with the following aims: to determine the prevalence of having a FH of CRC in FDR in the German population aged 40–54 years; to investigate the prevalence of colorectal neoplasms among people with a FDR; and to develop risk-adapted prevention strategies for this high-risk group based on the collected information. Data from large scale population-based studies on the prevalence of FH of CRC according to age, sex and other potential determinants, on the age and sex specific prevalence of colorectal neoplasms according to FH, on the use of CRC screening offers by those with a FH, and on the performance of potential noninvasive screening methods in this high risk group are sparse.

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