Trial document




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  DRKS00003095

Trial Description

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Title

Evaluation of novel serological markers for early diagnosis of colorectal neoplasia

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

With approximately 70,000 new cases per year, colorectal cancer (bowel cancer) is the most common type of cancer in Germany. Per year, almost 30,000 people in Germany die from this disease. Most of these deaths could, in theory, be prevented by early detection and removal of adenomas (benign tumors that may become malignant over time) and early stages of cancer by colonoscopy, a procedure during which the inside of the bowel is examined. This procedure is offered as primary screening examination in Germany since October 2002. However, many people choose not to take part in this screening examination, because the procedure is invasive and is often experienced as unpleasant. Therefore, additional, less invasive approaches to early detection are needed. There are some alternatives, such as tests for blood in stool, but they do not perform well in early detection, especially when it comes to detecting adenomas. Recently, three proteins that can be measured in blood, called colon cancer specific antigen (CCSA)-2, -3, and -4, have been identified. These proteins are reported to be promising in early detection of adenomas and bowel cancer in small-scale studies mostly conducted in hospitals. In this project, we will evaluate the performance of these three markers (individually and in combination) for early detection of adenomas and bowel cancer among 2,000 participants of the German colonoscopy screening program. We will compare these blood tests to the results of the colonoscopy in order to determine how well the blood tests perform in detection of adenomas and bowel cancer.

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Brief Summary in Scientific Language

With approximately 70,000 new cases per year, colorectal cancer (CRC) is the most common cancer in Germany. Most of the almost 30,000 CRC deaths per year could, in theory, be prevented by early detection and removal of adenomas and early cancer stages via colonoscopy which is offered as primary screening examination in Germany since October 2002. However, due to its invasiveness and discomfort, participation rates in screening colonoscopy remain low, and complementary, less invasive approaches to early detection are needed. Existing alternatives, such as fecal occult blood testing,suffer from poor sensitivity, especially with respect to adenomas. Recently, several colon cancer-specific serological markers, denoted colon cancer specific antigen (CCSA)-2, -3, and -4, have been identified and reported to have promising sensitivity and specificity in preliminary small-scale studies mostly conducted in clinical settings. In this multi-center project, performance of the three markers (individually and in combination) for early detection of CRC and advanced adenomas will be evaluated among 2,000 participants of the German colonoscopy screening program. Using findings at colonoscopy as gold standard, sensitivity and specificity will be determined at predefined cutpoints. Key secondary endpoints include positive and negative predictive values, ROC curves, likelihood ratios and numbers needed to screen.

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Organizational Data

  •   DRKS00003095
  •   2011/08/24
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  •   yes
  •   Approved
  •   S-178/2005, 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
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
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Interventions/Observational Groups

  •   Observational study: Participants in the colorectal cancer screening program, who undergo colonoscopy and a serological examination.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
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Primary Outcome

sensitivity and specificity of the three serological tests at predefined cutpoints with colonoscopy as gold standard for ascertainment of colorectal neoplasia

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Secondary Outcome

positive and negative predictive values, ROC curve and its area under the curve (AUC), likelihood ratios, number needed to screen

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2012/01/19
  •   2000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   55   Years
  •   75   Years
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Additional Inclusion Criteria

participants in screening colonoscopy, age 55-75, women, men, informed consent

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Exclusion Criteria

colonoscopy due to symptoms or a preceding positive colorectal cancer screening test, endoscopic examination of large bowel (colonoscopy, sigmoidoscopy) within the preceding 5 years, incomplete screening colonoscopy

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Addresses

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    • Deutsches Krebsforschungszentrum Heidelberg
    • Im Neuenheimer Feld 280
    • 69120  Heidelberg
    • Germany
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    • Deutsches Krebsforschungszentrum Heidelberg
    • Mr.  Professor Dr. med.  Hermann  Brenner 
    • Im Neuenheimer Feld 280
    • 69120  Heidelberg
    • Germany
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    • Deutsches Krebsforschungszentrum Heidelberg
    • Mr.  Jason  Hochhaus 
    • Im Neuenheimer Feld 280
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/09/09
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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.