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"CTC of the Unprepped Colon: Optimization & Validation"


N/A
40 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms

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Trial Information

"CTC of the Unprepped Colon: Optimization & Validation"


To improve the diagnostic performance of CTC in the prepared colon using improved spatial
resolution, advanced image displays, and computer-assisted diagnosis, and to optimize
diagnostic performance of CTC in the unprepared colon for colorectal polyp detection using
electronic stool subtraction and computer-aided diagnostic techniques. To estimate the
sensitivity and specificity of CTC in the unprepared colon for clinically important
colorectal neoplasms (large adenomas ≥ 1 cm) and to compare such estimates with colonoscopy.
To survey patient acceptance of CTC in the unprepared colon, and to assess implications
for health care costs and cost-effectiveness of CTC in the unprepared colon in comparison
with other approaches.


Inclusion Criteria:



Average risk or higher for colorectal cancer and scheduled for colonoscopy with any of the
following indications:

- Prior colorectal cancer, prior colorectal adenoma, strong family history of
colorectal neoplasia, iron deficiency.

- Age ≥ 40 -100 years

- Known or highly suspected primary colorectal neoplasms > 10 mm (n = 160)

- Higher than average risk for colorectal cancer and scheduled for colonoscopy with any
of the following indications: prior colorectal cancer, prior colorectal adenoma,
strong family history of colorectal neoplasia, iron deficiency.

Exclusion Criteria:

- Less than 1/2 of colorectum remaining

- Inflammatory bowel disease (Crohns, Chronic Ulcerative Colitis)

- Familial Polyposis

- Melena, hematochezia

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To optimize diagnostic performance of CTC in the unprepared colon for colorectal polyp detection using electronic stool subtraction and computer-aided diagnostic techniques.

Outcome Time Frame:

2000-2009

Safety Issue:

No

Principal Investigator

C. Daniel Johnson, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

1221-00

NCT ID:

NCT00586053

Start Date:

August 2000

Completion Date:

December 2009

Related Keywords:

  • Colorectal Neoplasms
  • Colonic Polyps
  • Colon
  • Large Intestine
  • Cecum
  • Sigmoid
  • Rectum
  • Colonoscopy
  • Virtual Colonoscopy
  • CT Colonography
  • Computed Tomographic Colonography
  • Colonography
  • Neoplasms
  • Colorectal Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905