Trial document




drksid header

  DRKS00019010

Trial Description

start of 1:1-Block title

Title

Sigmoidoscopy as an evidence-based colorectal cancer screening – a possible option?

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

SIGMO

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

https://www.mh-hannover.de/38345.html

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

In Germany, people can choose between a test that checks for hidden blood in the stool (stool test) or the examination of the inside of the colon using a thin, tube-like instrument inserted into the rectum (colonoscopy). It is recommended that persons, who reject the colonoscopy, should use the sigmoidoscopy, an examination of the lower colon, instead. However, to date, the sigmoidoscopy is unavailable. The objective is to analyse, 1. which of these three colorectal cancer screening methods (stool test, colonoscopy, sigmoidoscopy) is preferred and 2. what costs and benefits would be associated with the additional offer of the sigmoidoscopy. Therefore, we 1. analyse the preferences of 50 to 60 years old statutory insured persons by using a written survey. The 2. effects of the additional offer of the sigmoidoscopy for colorectal cancer screening on costs and benefits will be assessed with a decision model.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In Germany, people can choose between the immunologic fecal occult blood test and the colonoscopy for colorectal cancer screening. The Evidenced-based Guideline for Colorectal Cancer recommends the sigmoidoscopy for persons who reject the colonoscopy. However, the sigmoidoscopy is not covered by the statutory health insurance funds and therefore unavailable. The objective of this study is 1. to analyse the preferences of 50 to 60 years old statutory insured persons for colorectal cancer screening tests using a discrete-choice experiment. Furthermore, 2. decision analytic modelling (decision tree and Markov model) comparing the current colorectal cancer screening program (iFOBT, colonoscopy) with an extended screening strategy (iFOBT, colonoscopy, sigmoidoscopy) will be performed.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00019010
  •   2019/11/18
  •   [---]*
  •   yes
  •   Approved
  •   8671_BO_K_2019, Ethikkommission der Medizinischen Hochschule Hannover
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C18 -  Malignant neoplasm of colon
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   One-time survey in April/May 2020 of 50- to 60 years old statutory insured persons with a written, self administered questionnaire consisting of a) sociodemographic and health-related items, b) the discrete choice experiment and c) items asking for the intention to participate and the preferred colorectal cancer screening test.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Health economics
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Primary outcome (first project phase - discrete-choice experiment):
Estimating the contribution of attributes and levels to overall utility (part-worth utilities).

Primary outcome (second project phase - decision analytic modelling):
Cost-effectiveness of an extended screening strategy (iFOBT, colonoscopy, sigmoidoscopy) compared to the current colorectal cancer screening program (iFOBT, colonoscopy).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Secondary outcomes (first project phase - discrete-choice experiment):
1. The (hypothetical) colorectal cancer screening method that is preferred by statutory insured persons.
2. Estimation of the relevance of different attributes of colorectal cancer screening methods to overall utility.

Secondary outcomes (second project phase - decision analytic modelling):
1. Effects (e.g. detection rate of colorectal cancer and adenomas, colorectal cancer incidence and mortality, life years gained (LYG), quality adjusted life years (QALY)).
2. Determination of costs that are associated with the extended screening program.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2020/04/15
  •   940
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   60   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

50- to 60 years old statutory insured persons

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Statutory insured persons with diagnosed colorectal cancer, statutory insured persons with a diagnosed bowel disease that is associated with an increased risk for colorectal cancer (e.g. ulcerative colitis or Crohn's disease)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Medizinische Hochschule Hannover (MHH) Institut für Epidemiologie, Sozialmedizin und Gesundheitssystemforschung
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • AOK - Die Gesundheitskasse für Niedersachsen
    • Mr.  Dr.  Jona Theodor  Stahmeyer 
    • Hildesheimer Straße 273
    • 30519  Hannover
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Zentrum für Krebsregisterdaten (ZfKD) im Robert Koch-Institut in Berlin
    • Mr.  Dr.  Klaus  Kraywinkel 
    • Nordufer 20
    • 13353  Berlin
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Medizinische Hochschule Hannover (MHH) Zentrum für Innere Medizin
    • Ms.  Prof. Dr. med.  Ursula  Seidler 
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Medizinische Hochschule Hannover (MHH) Institut für Epidemiologie, Sozialmedizin und Gesundheitssystemforschung
    • Ms.  Dr.  Gabriele  Seidel 
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Medizinische Hochschule Hannover (MHH) Institut für Epidemiologie, Sozialmedizin und Gesundheitssystemforschung
    • Ms.  Dr. med.  Maren  Dreier, MPH 
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address scientific-contact
    • Medizinische Hochschule Hannover (MHH) Institut für Epidemiologie, Sozialmedizin und Gesundheitssystemforschung
    • Mr.  Prof. Dr.  Christian  Krauth 
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Medizinische Hochschule Hannover (MHH) Institut für Epidemiologie, Sozialmedizin und Gesundheitssystemforschung
    • Ms.  Melanie  Brinkmann 
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Innovationsfonds des Innovationsausschusses beim Gemeinsamen Bundesausschuss (G-BA)
    • Postfach 12 06 06
    • 10623  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.