Screening and Risk Factors of Colon Neoplasia
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms; Neoplasms
Study type: Observational

Summary: 
      The investigators propose a screening population-based study to systematically evaluate the
      accuracy and clinical relevance of sDNA testing as a potential alternative to colonoscopy
      screening. In addition, the investigators propose a genetic epidemiologic study of the
      relation between colon polyps, an established precursor of colon cancer, and two factors that
      may influence risk for colon cancer: candidate genes and diet.
    

Detailed description: 
      Colorectal carcinoma is currently the second most common fatal cancer in the United States,
      and is largely preventable through the use of screening in the asymptomatic population.
      Although colonoscopy is considered to be the most accurate 'gold standard' screening test,
      there are a significant proportion of eligible patients who decline colonoscopy or in whom
      colonoscopy is not readily available. More recently, testing for aberrant molecular/genetic
      markers in stool DNA (sDNA) is emerging as a promising alternative to colonoscopy, and some
      professional society guidelines have endorsed the use of sDNA testing in the early detection
      of colorectal cancer. However, despite some guidelines that endorse sDNA testing primarily
      for the detection of colorectal cancer, data on the efficacy of sDNA testing for advanced
      adenomas, and hence prevention of colorectal cancer, are limited.

      Colon carcinogenesis is a multifactorial and multistep process that involves both genetic and
      environmental influences. Diet clearly plays an important role. However, despite extensive
      research, there has been limited success in identifying such specific dietary and nutritional
      factors. In particular, a number of within-population studies, including several randomized
      trials, have yielded conflicting results and cast serious doubt on the hypothesized central
      role of dietary fat and fiber in colon carcinogenesis. In contrast, there is increasing
      evidence relating colon neoplasia to obesity, type 2 diabetes and related metabolic
      abnormalities. These results, together with the marked and consistent similarities in the
      dietary and lifestyle risk factors for type 2 diabetes and colon neoplasia have led to the
      notion that insulin resistance resulting from energy imbalance (excess energy intake,
      physical inactivity, and obesity) may be the underlying link between these two entities.
      Indeed, the insulin resistance-colon neoplasia hypothesis could account for many of the
      dietary and lifestyle risk factors of colon neoplasia and for its high incidence in Western
      countries. The fact that the incidences of obesity, insulin resistance syndrome, and type 2
      diabetes are escalating at epidemic pace in the Western societies makes the exploration of
      the insulin resistance-colon neoplasia hypothesis a subject of pressing priority.

      A Food Frequency Questionnaire (FFQ), a Meat Preparation Questionnaire (MPQ), and a Physical
      Activity Questionnaire (PAQ), all developed at the University of Arizona Cancer Center will
      be used to collect dietary and physical activity data.The FFQ, MPQ and PAQ questionnaires
      will be self-administered by each subject according to detailed written instructions, and
      they are mailed to the participant with the consent forms. Subjects will be asked to donate
      whole blood and urine samples on the day of routine colonoscopy exams. These samples will be
      looked at for disease markers. Stool samples will be collected to evaluate its use at
      detecting colon polyps using the sDNA Test and 2 FIT tests (fecal immunochemical test).
    

Intervention name(s): Stool DNA Test; biopsies of rectal and colon mucosa; Questionnaires
Intervention type(s): Other; Procedure; Other
Intervention description(s): Stool DNA test is done prior to the colonoscopy.; During the standard of care colonoscopy biopsies of rectal and colon mucosa will be taken for analysis of 15-PGDH pathway factors [levels of prostaglandin E2 (PG E2), and mRNA for 15-PGDH, COX-1 and COX-2 expression] as markers of risk of developing adenoma.; A Food Frequency Questionnaire (FFQ), a Meat Preparation Questionnaire (MPQ), and a Physical Activity Questionnaire (PAQ), all developed at the University of Arizona Cancer Center will be used to collect dietary and physical activity data. Risk Factor Questionnaire (RFQ) developed by the University of Southern California will be used to collect general risk information. Stool (sDNA) test patient satisfaction survey.
Other intervention name(s): sDNA; Food Frequency Questionnaire (FFQ); Meat Preparation Questionnaire (MPQ); Physical Activity Questionnaire (PAQ); Risk Factor Questionnaire (RFQ)
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Average-risk patients undergoing colonoscopy at screening endoscopy centers in the
        University Hospitals of Cleveland system.
      
Biospecimen description: 
      Whole Blood, Urine, Stool samples, Colon polyps
    
Keywords: Colon Neoplasia; Colorectal carcinoma; colon cancer; colon polyp; colonoscopy; sDNA test; FIT tests (fecal immunochemical test); relating colon neoplasia to obesity, type 2 diabetes; colonoscopy and pathology confirmed advanced adenomas