Colorectal Neoplasia Screening w Colonoscopy in Asymptomatic Women at Regional Navy/Army Medical Ctrs: The CONCeRN Trial

NCT00339950 | Completed

• 2 other identifiers: 999900010OH00-C-N010
• Study Type: observational
• Target: 937
• Locations: 1 country
• Sites: 3

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.

Conditions

Colorectal Adenoma

Keywords

Colorectal adenoma; Screening; Diet; Risk Factors

Study Arms (1)

1

Asymptomatic women between the ages of 40 and 75 referred to regional military medical centers for routine colorectal screening

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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@@@

You may qualify if:

• , asymptomatic women of average risk referred for colorectal screening.
• year-old asymptomatic women referred for colorectal screening with a history of colorectal cancer in a first degree relative.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (3)

Naval Medical Center, San Diego

San Diego, California, 92134-5000, United States

Location

National Naval Medical Center

Bethesda, Maryland, 20889, United States

Location

Naval Medical Center, Portsmouth

Portsmouth, Virginia, 23708, United States

Location

Related Publications (3)

• Adamson RH, Thorgeirsson UP, Snyderwine EG, Thorgeirsson SS, Reeves J, Dalgard DW, Takayama S, Sugimura T. Carcinogenicity of 2-amino-3-methylimidazo[4,5-f]quinoline in nonhuman primates: induction of tumors in three macaques. Jpn J Cancer Res. 1990 Jan;81(1):10-4. doi: 10.1111/j.1349-7006.1990.tb02500.x.

  PMID: 1691162 BACKGROUND

• 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.

  PMID: 3519419 BACKGROUND

• 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.

  PMID: 8679449 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood, colon tissue

Study Officials

• Rashmi Sinha, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: February 14, 2000
• Primary Completion: July 16, 2020
• Study Completion: July 16, 2020
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

US (3)