Trial document





This trial has been registered retrospectively.
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  DRKS00007842

Trial Description

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Title

Risk adapted prevention strategies for colorectal cancer

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Trial Acronym

RaPS

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URL of the Trial

http://www.rapsstudie.de/raps/

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Brief Summary in Lay Language

People aged 40-60 years with a history of colorectal cancer (CRC) in a 1st degree relative (parents, siblings) have a 2-to 4-fold increased risk of CRC compared to the average risk population. Therefore, German guidelines recommend starting CRC screening earlier in this high risk group (e.g., offering a first screening colonoscopy at age 40). However, information on prevalence of relevant colonoscopic findings in this group is sparse, and no risk adapted screening offers are made in the German health care system (i.e., screening colonoscopy is uniformly offered from age 55 on).
The RaPS study (Risk-adapted Prevention Strategies for colorectal cancer) is a multicentral epidemiological study which is carried out by the German Cancer Research Center in Heidelberg in cooperation with German Cancer Consortium partner sites in Dresden, Munich and Stuttgart. The RaPS study consists of two phases. In phase 1, random samples of the general population aged 40-54 from the catchment areas of the participating centers in Dresden, Munich and Stuttgart (around 160,000 persons) will be screened for increased CRC risk due to family history by online questionnaire. The main aim of this phase is to examine the prevalence of a history of CRC in 1st and 2nd degree relatives among men and women in the German population aged 40-54 years. In phase 2, those participants with a history of CRC in at least one 1st degree relative will be invited to individual consultation regarding CRC prevention, followed by a colonoscopy at the participating centers (if suggested by the gastroenterologist and agreed to by the participant). This phase aims to answer following research questions: What are the prevalences of colorectal neoplasms (CRC, adenomas) among people with a 1st degree relative with CRC? To what extent can biomarkers in blood predict the presence of colorectal neoplasms among people with a family history of CRC? To what extent can this information be used for effective risk stratification and personalized, targeted screening?
The proposed project provides the necessary empirical evidence for more effective, risk adapted CRC prevention among those at highest risk, i.e., people with a family history of CRC.

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Brief Summary in Scientific Language

People aged 40-60 years with a history of colorectal cancer (CRC) in a 1st degree relative have a 2-to 4-fold increased risk of CRC compared to the average risk population. Therefore, expert panels recommend starting CRC screening earlier for this high risk group (e.g., offering a first screening colonoscopy at age 40). However, information on prevalence of relevant colonoscopic findings and their variation in this group is sparse, and no risk adapted screening offers are made in the German health care system (i.e., screening colonoscopy is uniformly offered from age 55 on).
The RaPS study (Risk-adapted Prevention Strategies for colorectal cancer) is a multicentral epidemiological study which is carried out by the German Cancer Research Center in Heidelberg in cooperation with German Cancer Consortium (DKTK) partner sites in Dresden, Munich and Stuttgart. The aims of the RaPS study are:
1. To provide the necessary empirical evidence for the design and implementation of efficient risk adapted CRC screening strategies among the high risk group of people with family history of CRC.
2. To identify and evaluate novel biomarkers for noninvasive risk stratification and early detection of CRC and its precursors among people with family history of CRC.
In phase 1, random samples of the general population aged 40-54 from the catchment areas of the participating centers in Dresden, Munich and Stuttgart will be screened for increased CRC risk due to family history by an online questionnaire. All respondents will receive feedback and recommendations concerning their individual risks factors. In phase 2, those participants with a history of CRC in a 1st degree relative will be invited to individual consultation regarding CRC prevention, followed by a colonoscopy at the participating centers (if suggested by the gastroenterologist and agreed to by the participant). Prevalence of CRC and its precursors (in particular advanced adenomas) will be evaluated according to age and sex of the participants, number, type and age at diagnosis of affected 1st degree relatives, additional risk factors, genetic, epigenetic, proteomic and microbiomic risk markers. Implications for risk adapted screening offers (including effectiveness and cost-effectiveness) will be derived. A biorepository (blood, stool) for interdisciplinary translational research within DKTK will be set up.
This project provides a comprehensive approach to CRC prevention among high-risk individuals with family history of CRC. The study will, for the first time, obtain the necessary data for deriving evidence based screening guidelines for the high risk group of people with a family history of CRC in Germany.

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Organizational Data

  •   DRKS00007842
  •   2016/12/29
  •   [---]*
  •   yes
  •   Approved
  •   S-550/2014, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C18 -  Malignant neoplasm of colon
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Interventions/Observational Groups

  •   Persons without family history of colorectal cancer: to fill out online-questionnaire
  •   Persons with family history of colorectal cancer: to fill out online-questionnaire, take part in consultation regarding colorectal cancer prevention and donate the biosamples
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The aims of the RaPS study are:
1. To provide the necessary empirical evidence for the design and implementation of efficient risk adapted CRC (colorectal cancer) screening strategies among the high risk group of people with family history of CRC.
2. To identify and evaluate novel biomarkers for noninvasive risk stratification and early detection of CRC and its precursors among people with family history of CRC.

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2015/06/01
  •   30000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   54   Years
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Additional Inclusion Criteria

Being part of drawn random samples of the general population aged 40-54 from the catchment areas of the participating centers in Dresden, Munich and Stuttgart (around 160,000 persons); sufficient German

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Exclusion Criteria

Not in random samples or insufficient German

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Addresses

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    • Deutsches Krebsforschungszentrum, Deutsches Konsortium für Translationale Krebsforschung
    • Im Neuenheimer Feld 280
    • 69120  Heidelberg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Deutsches Krebsforschungszentrum
    • Mr.  Prof  Hermann  Brenner 
    • Im Neuenheimer Feld 581
    • 69120  Heidelberg
    • Germany
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    • Deutsches Krebsforschungszentrum
    • Ms.  Dr  Kaja  Tikk 
    • Im Neuenheimer Feld 581
    • 69120  Heidelberg
    • Germany
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    •   +496221421301
    •   +49 6221421302
    •   raps at dkfz.de
    •   [---]*
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.