Trial document





This trial has been registered retrospectively.
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  DRKS00015097

Trial Description

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Title

Prevention of Familial Risk of Colorectal Carcinoma

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Trial Acronym

FARKOR

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URL of the Trial

https://www.darmkrebs-in-der-familie.de/

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Brief Summary in Lay Language

Colorectal cancer (CRC) is the second most common malignant disease and the second most frequent cause of cancer death in Germany. Official CRC screening starts at age 50. However, about 10% of CRC cases are diagnosed before the age of 55. Moreover, there is evidence that individuals with a family history of CRC have a 2- to 4-fold increased risk of developing colorectal carcinoma. This results in a CRC incidence similar to that of individuals without a family history of CRC who are 10 to 15 years older. Despite recommendations to start CRC screening in this risk group before age 50 years, there are currently no risk-adapted screening programs for individuals with a family history of CRC in Germany and in many other countries. In the FARKOR project, the aim is to identify individuals with a family history of CRC at an earlier age, i.e. between 25 and 50 years. The recruitment of participants is multimodal. Insurance companies contact patients recently diagnosed with CRC to alert them to the potentially increased risk of their relatives as compared to the general population. Moreover, physicians recruit individuals between 25 and 50 years of age to participate in the screening program. Finally, there will be a public campaign for the program. Participants are invited to participate in a short standardized interview regarding family history of CRC which is based on a simplified version of the Amsterdam and Bethesda criteria. Potential risk carriers are informed in a counseling session about the risks of CRC as well as the risks and benefits of various screening examinations. In a shared decision making session, the participants can decide on screening options which consist of an iFOBT, a screening colonoscopy or deferring further actions to a later point in life. Additionally, potential risk carriers have the opportunity to participate in an in-depth questionnaire on family history of CRC and all participants are invited to fill out an online questionnaire on their lifestyle. The aim of the project is to offer a risk-adapted colorectal cancer screening in individuals between 25 and 50 years of age. A health-economic analysis in Germany will evaluate the long term benefits, harms and cost-effectiveness of the risk-adapted CRC screening program.

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Brief Summary in Scientific Language

In Germany, more than 60,000 are diagnosed with colorectal carcinoma (CRC) each year, and about 25,000 people die from this disease. It is the second most malignant disease and the second most common cause of cancer death in Germany. As a high proportion of CRC develops from benign precancerous leasions for which efficient medical therapeutically options exist, screening can be efficient in the prevention of CRC. Both randomized and observational studies show that the early detection of carcinomas and their precursors of carcinomas can favorably influence cancer incidence and mortality. Since 2002, statuary health insured individuals in Germany are entitled to a stool test (FOB) starting at the age of 50 and to a colonoscopy starting at the age of 55, as a cancer screening procedure. The right to colorectal screening is exclusively linked to the age group (from the age of 50). This, however, ignores major risk factors in the genesis of colon cancer and its resulting mortality. About 10% of the new cases of CRC are being detected in persons under the age of 50 and in particular in individuals with a family history of CRC, who have an increased risk of developing CRC before the age of 50. In this age group, persons with a family history have a 2- to 4-fold increased risk of developing colorectal carcinoma and the morbidity rate in this risk group is similar to that of person 10 to 15 years older without a family history of CRC. The data that will be collected in the study will allow to evaluate the acceptance of the screening program, its positive effects in the sense of an early detection of prevalent cases of CRC and precancerous lesions as well as its negative effects.

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Organizational Data

  •   DRKS00015097
  •   2019/01/15
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  •   yes
  •   Approved
  •   18-545 , Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   C18 -  Malignant neoplasm of colon
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
  •   D12 -  Benign neoplasm of colon, rectum, anus and anal canal
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Interventions/Observational Groups

  •   Members of statutory health insurance between 25 and 50 years living in Bavaria are invited to participate in the study.
    Based on a short questionnaire on their family history of colorectal cancer (CRC), which is a simplified version of the Amsterdam and Bethesda criteria, participants are classified as potential risk carrier or as risk free.
    Participants with a family history of CRC can decide to undergo an iFOBT (fecal immunochemical test), a screening colonoscopy, or deferring further actions to a later point in life.
    Participants in arm 1 are study participants with a family history of CRC who decide for one of the proposed screening measures.
  •   Participants between 25 and 50 years living in Bavaria without family history of CRC
  •   In arm 3, the incidence of CRC in members of statutory health insurance companies between 25 and 50 years of age living in Bavaria who do not participate in the study will be monitored through health administrative databases.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Screening
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

The incidence of adenoma and of CRC in study participants who undergo one of the proposed screening options will be measured in the context of this screening option.
The incidence of adenoma and of CRC in study participants who do not participate in any screening measures and in those who do not participate in the program will be estimated based on administrative health records during the project period. The statistical analysis will take the difference in detection probabilities of adenoma and of CRC in the different groups in account.

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Secondary Outcome

- participation rate
- number of complications arising in the screening colonoscopies in the program
- positive predictive value of iFOBT (immunological fecal occult blood test): frequency of true and false positive findings

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2018/10/01
  •   90000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   25   Years
  •   50   Years
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Additional Inclusion Criteria

25 -> 50 year-old persons of both genders, with and without family history of CRC, who gave their written consent to participate in the project

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Exclusion Criteria

Individuals for whom adequate CRC related screening measures already exist are excluded from the study. In particular, patients with an increased risk of CRC due to a known disease (family history of adenomatous polyposis, chronic inflammatory bowel diseases (ulcerative colitis, Chron's disease)) or with a previous diagnosis of CRC will be excluded, as well as patients over 50 years of age for whom CRC screening already exists.

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Addresses

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    • Kassenärztliche Vereinigung Bayerns
    • Ms.  Patrizia   Ungar 
    • Elsenheimerstr. 39
    • 80687  München
    • Germany
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    • AOK Bayern - Die Gesundheitskasse
    • Carl-Wery-Str. 28
    • 81739  München
    • Germany
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    • Verband der Ersatzkassen e. V.
    • Arnulfstr. 201 a
    • 80634  München
    • Germany
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    • Techniker Krankenkasse
    • Rosenheimer Str. 141
    • 81671  München
    • Germany
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    • BARMER
    • Landsberger Str. 187
    • 80687  München
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    • DAK-Gesundheit
    • Haidenauplatz 3
    • 81667  München
    • Germany
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    • BKK Landesverband Bayern
    • Züricher Str. 25
    • 81476  München
    • Germany
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    • KNAPPSCHAFT, Regionaldirektion München
    • Putzbrunner Str. 73
    • 81739  München
    • Germany
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    • Ludwig-Maximilians-Universität München
    • Geschwister-Scholl-Platz 1
    • 80539  München
    • Germany
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    • UMIT – Private Universität für Gesundheitswissenschaften, Medizinische Informatik und Technik GmbH
    • Eduard Wallnöfer-Zentrum 1
    • 6060  Hall in Tirol
    • Austria
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    • Hubert Burda Stiftung
    • Hauptstraße 130
    • 77652  Offenburg
    • Germany
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    • Institut für Medizinische Informationsverarbeitung Biometrie und Epidemiologie
    • Mr.  Prof. Dr.  Ulrich  Mansmann 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • Kassenärztliche Vereinigung Bayerns (KVB) FARKOR Koordinationsstelle
    • Ms.  Patrizia  Ungar 
    • Elsenheimerstr. 39
    • 80687  München
    • Germany
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    •   0049 89 5 70 93 0
    •   0049 89 5 70 93 64 981
    •   FARKOR at KVB.de
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Sources of Monetary or Material Support

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    • Gemeinsamer Bundesausschuss
    • Gutenbergstraße 13
    • 10587  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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