Colorectal Neoplasia Screening w Colonoscopy in Asymptomatic Women at Regional Navy/Army Medical Ctrs: The CONCeRN Trial
Condition: Colorectal Adenoma
MeSH terms: Adenoma
Study type: Observational

Summary: 
      The CONCeRN Trial is a multi-center study of asymptomatic women between the ages of 40 and 75
      referred to regional military medical centers for routine colorectal screening. The primary
      purpose of the main study is to determine the extent to which advanced neoplastic lesions
      will be missed if clinicians only perform sigmoidoscopies rather than full colonoscopies as a
      screening procedure and to resolve current debate about the significance of sigmoidoscopic
      detection of single, small, tubular adenomas (i.e., do they imply greater risk for large
      adenomatous polyps or colorectal cancer at other sites beyond the reach of the sigmoidoscope,
      or is there no increased risk?). Women enrolled in the trial receive colonoscopy during which
      all identified polyps are removed and also during which two pinch biopsies of
      apparently-normal tissue are taken. In addition, before the colonoscopy is performed,
      patients wil have blood drawn and answer a brief questionnaire on risk factors for colorectal
      cancer. The sub-study proposes to add on a more extensive questionnaire to assess dietary and
      other lifesyle factors potentially related to colorectal cancer, and to draw additional blood
      for assessment of nutritional status and for analysis of genetic polymorphisms related to
      colorectal cancer. With the additional information available from these questionnaires and
      blood samples, it will be possible to explore the extent to which various dietary and genetic
      risk factors are related to colorectal polyps in asymptomatic women of average risk for
      disease.
    

Detailed description: 
      The CONCeRN Trial is a multi-center study of asymptomatic women between the ages of 40 and 75
      referred to regional military medical centers for routine colorectal screening. The primary
      purpose of the main study is to determine the extent to which advanced neoplastic lesions
      will be missed if clinicians only perform sigmoidoscopies rather than full colonoscopies as a
      screening procedure and to resolve current debate about the significance of sigmoidoscopic
      detection of single, small, tubular adenomas (i.e., do they imply greater risk for large
      adenomatous polyps or colorectal cancer at other sites beyond the reach of the sigmoidoscope,
      or is there no increased risk?). Women enrolled in the trial receive colonoscopy during which
      all identified polyps are removed and also during which two pinch biopsies of
      apparently-normal tissue are taken. In addition, before the colonoscopy is performed,
      patients will have blood drawn and answer a brief questionnaire on risk factors for
      colorectal cancer. The NCI-led sub-study added a more extensive questionnaire to assess
      dietary and other lifestyle factors potentially related to colorectal cancer, and obtained
      additional blood for assessment of nutritional status and for analysis of genetic
      polymorphisms related to colorectal cancer. With the additional information available from
      these questionnaires and blood samples, it will be possible to explore the extent to which
      various dietary and genetic risk factors are related to colorectal polyps in asymptomatic
      women of average risk for disease. Recruitment is now complete at all sites. A total of 937
      women were recruited. Of these, about one-quarter of the women with one or more adenomas had
      an advanced adenoma, defined as being greater than or equal to 1 cm in diameter, or having
      high grade dysplasia or villous elements). These neoplasia prevalence figures are in line
      with initial projections. Active contact with participants is concluded. We have now entered
      into a data analysis phase.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Asymptomatic women between the ages of 40 and 75 referred to regional military medical
        centers for routine colorectal screening@@@
      
Biospecimen description: 
      blood, colon tissue
    
Keywords: Colorectal adenoma; Screening; Diet; Risk Factors