Trial document





This trial has been registered retrospectively.
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  DRKS00003503

Trial Description

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Title

Prevalence of colorectal cancer in symptomatic and asymptomatic patients undergoing total coloscopy

A prospective, multi-center, case-control endoscopy study in a federal state in Germany

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Patients undergoing a colonoscopic workup of symptoms like abdominal pain, bloody stools or colonic obstruction were compared with asymptomatic screening colonoscopy participants with respect to detection of colorectal cancer and its precursor lesions.

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Brief Summary in Scientific Language

This study was undertaken to determine the prevalence of CRC and its precursor lesions in symptomatic patients (age >55 years) undergoing colonoscopy in comparison to an age- and gender-matched asymptomatic control population undergoing screening colonoscopy.

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Organizational Data

  •   DRKS00003503
  •   2013/09/03
  •   [---]*
  •   yes
  •   Approved
  •   126/02, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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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

  •   Symptomatic patients undergoing colonoscopy were investigated with respect to colon cancer and its precursor lesions
  •   Asymptomatic screening participants were matched with patients from arm1 with respect to age and gender.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Screening
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Prevalence of colorectal cancer and its precursor lesions in patients undergoing total colonoscopy in comparison to screening participants.

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Secondary Outcome

n/a

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2009/10/01
  •   1075
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   55   Years
  •   no maximum age
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Additional Inclusion Criteria

patients undergoing colonoscopy under outpatient conditions. Only patients undergoing first colonoscopy in life were evaluated. Symptoms included tumour-suspicious symptoms (altered bowel habits, weight loss, anaemia, anorectal bleeding, positive fecal occult blood tests (FOBT), abdominal pain, constipation or diarrhoea). Eligible patients provided written informed consent. Complete colonoscopy is mandatory.

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Exclusion Criteria

Persons with increased risk for CRC (surveillance after resection of a CRC, surveillance after polypectomy, known inflammatory bowel disease, FAP, HNPCC) and persons with the history of colorectal surgery were excluded in both study groups. The completeness of colonoscopy was a prerequisite for inclusion in both studies as well as for reimbursement by the health insurance

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinik Frankfurt am Main
    • Mr.  Prof. Dr. Dr.  Oliver  Schröder 
    • Theodor-Stern-Kai 07
    • 60590  Frankfurt
    • Germany
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    • Universitätsklinikum Frankfurt am Main
    • Ms.  Dr.  Irina  Blumenstein 
    • Theodor-Stern-Kai 07
    • 60590  Frankfurt am Main
    • Germany
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    • Universitätsklinikum Frankfurt am Main
    • Ms.  Dr.  Irina  Blumenstein 
    • Theodor-Stern-Kai 07
    • 60590  Frankfurt am Main
    • Germany
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Sources of Monetary or Material Support

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    • Taunus BKK
    • Wächtersbacher Str. 89
    • 60386  Frankfurt am Main
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2010/09/30
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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.