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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Screening Study of Colonoscopy Versus Annual Fecal Occult Blood Test in Healthy Participants at Average Risk for Colorectal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Screening Active 50 to 69 (40 to 69 at LSU site) NCI MSKCC-00046A NCT00102011, UMN-2003NT062

Trial Description

Purpose:

Screening tests, such as colonoscopy and fecal occult blood test, may help doctors find tumor cells early and plan better treatment for colorectal cancer.

This randomized phase III trial is studying colonoscopy to see how well it works compared to fecal occult blood test in screening healthy participants for colorectal cancer.

Eligibility:

Eligibility criteria include the following:

• 40-69 years old
• No previous colorectal cancer
• No previous familial polyposis
• More than 5 years since sigmoidoscopy
• No previous colonoscopy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Participants will be randomly assigned (have an equal chance of being placed in one of two screening groups).

Participants in group one will undergo colonoscopy. They will receive recommendations for further screening based on the results of the colonoscopy.

Participants in group two will undergo fecal occult blood test. They will receive recommendations for further screening based on the results of the fecal occult blood test. Some participants will undergo additional fecal occult blood tests once a year for up to 4 years.

Participants will be evaluated once a year for up to 4 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Sidney Winawer, MD, Protocol chair		Ph: 212-639-7675; 800-525-2225 Email: winawers@mskcc.org

U.S.A.
Louisiana
	Shreveport
	Feist-Weiller Cancer Center at Louisiana State University Health Sciences
		Clinical Trials Office - Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Ph:  318-813-1412
Minnesota
	Minneapolis
	Masonic Cancer Center at University of Minnesota
		Clinical Trials Office - Masonic Cancer Center at University of Minnesota	Ph:  612-624-2620
Washington
	Seattle
	Group Health Central Hospital
		Clinical Trials Office - Group Health Central Hospital	Ph:  206-287-2900

Registry Information
Official Title		Colonoscopy Screening Trial
Trial Start Date		2000-05-01
Trial Completion Date		2010-05-03 (estimated)
Registered in ClinicalTrials.gov		NCT00102011
Date Submitted to PDQ		2004-12-29
Information Last Verified		2008-12-14
NCI Grant/Contract Number		P30-CA08748