Screening and Risk Factors of Colon Neoplasia
| Status: | Recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 30 - 80 |
| Updated: | 3/2/2019 |
| Start Date: | April 1, 2012 |
| End Date: | March 2019 |
| Contact: | Ashutosh Sheth |
| Email: | colonpolypstudy@case.edu |
| Phone: | 216-286-5005 |
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.
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.
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).
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).
Inclusion Criteria:
- patients undergoing routine colonoscopy at University Hospitals, Cleveland Ohio
Exclusion Criteria:
- Unable to give written consents
- Unable to fill the questionnaires
- A history of polyps within the past 10 years (except hyperplastic polyps)
- Family history of Familial Adenomatous Polyposis (FAP) or Hereditary Non-Polyposis
Colorectal Cancer (HNPCC)
- Personal history of inflammatory bowel disease
- Personal diagnosis of any cancer, with the exception of non-melanoma skin cancer
- Any major colon surgeries (e.g. resectioning)
We found this trial at
1
site
Cleveland, Ohio 44106
Phone: 216-844-8292
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