title: Positive family history of colorectal cancer in a general practice setting [FRIDA.Frankfurt]: study protocol of a of a cross-sectional study.
abstract: BACKGROUND
  Although the risk of developing colorectal cancer (CRC) is 2-4 times higher in case of a positive family history, risk-adapted screening programs for family members related to CRC- patients do not exist in the German health care system. CRC screening recommendations for persons under 55 years of age that have a family predisposition have been published in several guidelines. The primary aim of this study is to determine the frequency of positive family history of CRC (1st degree relatives with CRC) among 40-54 year old persons in a general practitioner (GP) setting in Germany. Secondary aims are to detect the frequency of occurrence of colorectal neoplasms (CRC and advanced adenomas) in 1st degree relatives of CRC patients and to identify the variables (e.g. demographic, genetic, epigenetic and proteomic characteristics) that are associated with it. This study also explores whether evidence-based information contributes to informed decisions and how screening participation correlates with anxiety and (anticipated) regret.
  
  
  METHODS
  Prior to the beginning of the study, the GP team (GP and one health care assistant) in around 50 practices will be trained, and about 8,750 persons that are registered with them will be asked to complete the "Network against colorectal cancer" questionnaire. The 10% who are expected to have a positive family history will then be invited to give their informed consent to participate in the study. All individuals with positive family history will be provided with evidence-based information and prevention strategies. We plan to examine each participant's family history of CRC in detail and to collect information on further variables (e.g. demographics) associated with increased risk. Additional stool and blood samples will be collected from study-participants who decide to undergo a colonoscopy (n ~ 350) and then analyzed at the German Cancer Research Center (DKFZ) Heidelberg to see whether further relevant variables are associated with an increased risk of CRC. One screening list and four questionnaires will be used to collect the data, and a detailed statistical analysis plan will be provided before the database is closed (expected to be June 30, 2015).
  
  
  CONCLUSIONS
  It is anticipated that when persons with a family history of colorectal cancer have been provided with professional advice by the practice team, there will be an increase in the availability of valid information on the frequency of affected individuals and an increase in the number of persons making informed decisions. We also expect to identify further variables that are associated with colorectal cancer. This study therefore has translational relevance from lab to practice.
  
  
  BACKGROUND
  German Clinical Trials Register DRKS00006277.
authors: Institute of General Practice, Goethe-University Frankfurt, Frankfurt am Main, Germany. siebenhofer@allgemeinmedizin.uni-frankfurt.de.|German Cancer Research Center (DKFZ), Heidelberg, Germany. siebenhofer@allgemeinmedizin.uni-frankfurt.de.|German Cancer Consortium (DKTK), Heidelberg, Germany. siebenhofer@allgemeinmedizin.uni-frankfurt.de.|Institute of General Practice and Evidence-based Health Services Research, Medical University of Graz, Graz, Austria. siebenhofer@allgemeinmedizin.uni-frankfurt.de.
authors: Andrea
authors: A
authors: Siebenhofer
authors: Institute of General Practice, Goethe-University Frankfurt, Frankfurt am Main, Germany. j.plath@dkfz-heidelberg.de.|German Cancer Research Center (DKFZ), Heidelberg, Germany. j.plath@dkfz-heidelberg.de.|German Cancer Consortium (DKTK), Heidelberg, Germany. j.plath@dkfz-heidelberg.de.
authors: Jasper
authors: J
authors: Plath
authors: Institute of General Practice, Goethe-University Frankfurt, Frankfurt am Main, Germany. taubenroth@allgemeinmedizin.uni-frankfurt.de.
authors: Maja
authors: M
authors: Taubenroth
authors: German Cancer Research Center (DKFZ), Heidelberg, Germany. singers@uni-mainz.de.|German Cancer Consortium (DKTK), Heidelberg, Germany. singers@uni-mainz.de.|Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), Johannes Gutenberg University Mainz, Mainz, Germany. singers@uni-mainz.de.
authors: Susanne
authors: S
authors: Singer
authors: German Cancer Research Center (DKFZ), Heidelberg, Germany. m.hechtner@dkfz-heidelberg.de.|German Cancer Consortium (DKTK), Heidelberg, Germany. m.hechtner@dkfz-heidelberg.de.|Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), Johannes Gutenberg University Mainz, Mainz, Germany. m.hechtner@dkfz-heidelberg.de.
authors: Marlene
authors: M
authors: Hechtner
authors: Institute of General Practice, Goethe-University Frankfurt, Frankfurt am Main, Germany. a.dahlhaus@dkfz-heidelberg.de.|German Cancer Research Center (DKFZ), Heidelberg, Germany. a.dahlhaus@dkfz-heidelberg.de.|German Cancer Consortium (DKTK), Heidelberg, Germany. a.dahlhaus@dkfz-heidelberg.de.
authors: Anne
authors: A
authors: Dahlhaus
authors: Institute of General Practice, Goethe-University Frankfurt, Frankfurt am Main, Germany. rauck@allgemeinmedizin.uni-frankfurt.de.
authors: Sandra
authors: S
authors: Rauck
authors: Institute of General Practice, Goethe-University Frankfurt, Frankfurt am Main, Germany. schulz-rothe@allgemeinmedizin.uni-frankfurt.de.
authors: Sylvia
authors: S
authors: Schulz-Rothe
authors: Institute of General Practice, Goethe-University Frankfurt, Frankfurt am Main, Germany. kone@allgemeinmedizin.uni-frankfurt.de.
authors: Insa
authors: I
authors: Koné
authors: Institute of General Practice, Goethe-University Frankfurt, Frankfurt am Main, Germany. gerlach@allgemeinmedizin.uni-frankfurt.de.
authors: Ferdinand M
authors: FM
authors: Gerlach
mesh_terms: D000236:Adenoma / Q000097:blood / Q000175:diagnosis*; D000328:Adult; D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000097:blood / Q000175:diagnosis*; D003430:Cross-Sectional Studies; D055088:Early Detection of Cancer; D005192:Family Health; D058006:General Practice; D005858:Germany; D006306:Health Surveys; D006801:Humans; D008875:Middle Aged; D009780:Occult Blood; D010817:Physician-Patient Relations; D011315:Preventive Medicine / Q000379:methods; D012107:Research Design; D018570:Risk Assessment