Clinical trial NCT00339950: Colorectal Neoplasia Screening w Colonoscopy in Asymptomatic Women at Regional Navy/Army Medical Ctrs: The CONCeRN Trial
Official title: Diet, Other Risk Factors, Genetics and the Risk of Colorectal Neoplasia in a Screening Trial of Asymptomatic Women: A Sub-Study of the CONCeRN Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Adenoma
Keywords: Colorectal adenoma
Screening
Diet
Risk Factors
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-06-21
Enrollment: 937
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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@@@

Brief 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.

Eligibility criteria: * INCLUSION CRITERIA:

50-79, asymptomatic women of average risk referred for colorectal screening.

40-79 year-old asymptomatic women referred for colorectal screening with a history of colorectal cancer in a first degree relative.

EXCLUSION CRITERIA:

History of positive stool guiaic within six months of referral.

History of iron deficiency anemia within six months of referral (Note: if patients have not had stool guiacs, complete blood cell count or ferritin performed within the last six months, then these tests will be performed at time of study enrollment).

History of normal colonoscopy or barium enema within past ten years or history of normal flexible sigmoidoscopy within past 5 years.

History of adenomatous polyps, colorectal cancer, inflammatory bowel disease, HNPCC, or familial adenomatous polyposis.

History of rectal bleeding or hematochezia within the past 12 months.

Unintentional weight loss greater than 10 pounds within previous six months.

Pregnant women.

Subjects under 18 years of age.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center, San Diego
state: California
city: Bethesda
country: United States
facility: National Naval Medical Center
state: Maryland
city: Portsmouth
country: United States
facility: Naval Medical Center, Portsmouth
state: Virginia
Study officials:
affiliation: National Cancer Institute (NCI)
name: Rashmi Sinha, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bosron WF, Li TK. Genetic polymorphism of human liver alcohol and aldehyde dehydrogenases, and their relationship to alcohol metabolism and alcoholism. Hepatology. 1986 May-Jun;6(3):502-10. doi: 10.1002/hep.1840060330.
citation: Boutron MC, Faivre J, Marteau P, Couillault C, Senesse P, Quipourt V. Calcium, phosphorus, vitamin D, dairy products and colorectal carcinogenesis: a French case--control study. Br J Cancer. 1996 Jul;74(1):145-51. doi: 10.1038/bjc.1996.330.