Status:

COMPLETED

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

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Colorectal Adenoma

Eligibility:

FEMALE

40-79 years

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...

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...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    February 14 2000

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    July 16 2020

    Estimated Enrollment :

    937 Patients enrolled

    Trial Details

    Trial ID

    NCT00339950

    Start Date

    February 14 2000

    End Date

    July 16 2020

    Last Update

    July 17 2020

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    Naval Medical Center, San Diego

    San Diego, California, United States, 92134-5000

    2

    National Naval Medical Center

    Bethesda, Maryland, United States, 20889

    3

    Naval Medical Center, Portsmouth

    Portsmouth, Virginia, United States, 23708