Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

Colorectal cancer (CRC) is currently the second most common cause of cancer death in the United States, and one of the most preventable cancers. It has been shown in several randomized controlled trials that screening using fecal occult blood testing (FOBT) reduces CRC mortality by 13-33%. While there is strong consensus amongst experts regarding the value of CRC screening, the best approach to screening is not clear. Of the widely recommended modalities, FOBT and colonoscopy are the most commonly used within the United States. FOBT is inexpensive, non-invasive, and its use as a screening tool is supported by the highest quality evidence (i.e. randomized controlled trials). Moreover, newer FOBT, such as fecal immunochemical tests or FITs, have advantages over conventional FOBT in terms of both test characteristics and ease of use that make them quite attractive as a population-based screening tool.

While colonoscopy is invasive and has higher up-front risks and costs than FOBT, it does afford the opportunity to directly assess the colonic mucosa and is widely believed to be the best test to detect colorectal cancer. In addition, colonoscopy allows for the detection and removal of colorectal adenomas -a well recognized colorectal cancer precursor. There is indirect evidence that suggests colonoscopy is effective in reducing colorectal cancer mortality, but to date, no large clinical trials have been completed to support this assumption. While colonoscopy use is increasing, data is emerging that colonoscopy may not be as effective as previously believed. Prior support for colonoscopy as a screening test relied upon effectiveness estimates that now appear to be overly optimistic. Given the invasive nature of colonoscopy, the associated small, but real risk of complications, and dramatically higher costs than other screening tests, it is especially important to determine the true comparative effectiveness of colonoscopy relative to other proven non-invasive options.

The investigators propose to perform a, large, simple, multicenter, randomized, parallel group trial directly comparing screening colonoscopy with annual FIT screening in average risk individuals. Our hypothesis is that colonoscopy will be superior to FIT in the prevention of colorectal cancer mortality measured over 10 years. Individuals will be enrolled if they are currently eligible for CRC screening (e.g. no colonoscopy in the past 10 years and no FOBT in the past 1 year) and are between 50 and 75 years of age. The investigators will exclude individuals for whom colonoscopy is indicated (e.g. signs or symptoms of CRC, first degree family member with CRC, personal history of colorectal neoplasia or inflammatory bowel disease).

All participants will complete baseline demographic, medication, and lifestyle questionnaires (e.g. diet, non-steroidal anti-inflammatory use, frequency of exercise) prior to randomization in a 1:1 ratio to either screening colonoscopy or annual FIT screening (Figure 1). Those testing positive by FIT will undergo evaluation to determine appropriateness for colonoscopy. Screening will be performed in a manner consistent with the currently accepted standard of care in order to determine the comparative effectiveness of the two screening strategies. Participants will be surveyed annually to determine if they have undergone colonoscopy or been diagnosed with CRC.

The primary study endpoint will be CRC mortality within 10 years of enrollment. The secondary endpoints are (1) the incidence of CRC within 10 years of enrollment and (2) major complications of colonoscopy. Mortality will be determined through queries of the VA Vital Status File. Cause of death will be determined primarily using death certificates from the National Death Index-Plus database, augmented by adjudication of medical records for known CRC cases where CRC is not listed as a cause of death on the death certificate. We postulate that screening colonoscopy will result in a 40% reduction in CRC mortality over 10 years relative to annual FIT screening. Using a log-rank test with a 2-sided test of significance, =0.05, a sample size of 50,000 participants will be required to test the primary hypothesis with 82% power, assuming a 1% annual rate of crossover from FIT to colonoscopy and a 0.5% annual rate of loss to follow-up. The planned study duration is 12.5 years with 2.5 years of recruitment and 10 years of follow-up for all enrolled participants.

Eligibility Criteria

Inclusion Criteria:

• Male and female adults aged 50-75 years of age:

• Able to provide informed consent

• Veteran eligible for VA care

Exclusion Criteria:

• Symptoms of lower gastrointestinal tract disease warranting colonoscopic evaluation, including:

• More than one episode of rectal bleeding within the past 6 months

• Documented iron deficiency anemia

• Significant documented unintentional weight loss (>10% of baseline weight) over 6 months

• Family history of CRC in a first degree relative at any age

• Prior history of colonic disease including:

• Inflammatory bowel disease (e.g. ulcerative colitis or Crohn's disease)

• One or more colorectal neoplastic polyps (i.e. adenomas)

• Colorectal cancer

• Prior history of colonic resection

• Prior colonic examination, including:

• Colonoscopy within the past 10 years

• Sigmoidoscopy within the past 5 years

• Barium enema within the past 5 years

• CT colonography within the past 5 years

• gFOBT or FIT in the past 12 months

• Pregnancy

• Prisoner

• Significant comorbidity that would preclude benefit from screening or pose significant risk for the performance of colonoscopy (e.g. severe lung disease, end-stage renal disease, end-stage liver disease, severe heart failure, cancer)

• Participation in a concurrent interventional study

• Likely inability to track the individual over time (e.g. no permanent address at the time of screening for study entry)

Trial Contact Information

Trial Lead Organizations/Sponsors

Department of Veterans Affairs - Central Office

Jason A. Dominitz

Study Chair

Douglas J. Robertson, MD MPH

Study Chair

Robert F Wallace, ScD		Ph: (203) 932-5711 Ext.3776
		Email: robert.wallace3@va.gov

U.S.A.
Arizona
	Phoenix
	Veterans Affairs Medical Center - Phoenix
		Charles H Beymer, MD	Ph: 602-277-5551 Ext.7795
			Email: charles.beymer@va.gov
California
	Loma Linda
	Veterans Affairs Medical Center - Loma Linda (Pettis)
		Christian S Jackson, MD	Ph: 909-825-7084 Ext.1184
			Email: christian.jackson@va.gov
	Long Beach
	Veterans Affairs Medical Center - Long Beach
		Mazen Jamal, MD	Ph: 562-826-5628
			Email: mazen.jamal@va.gov
	San Diego
	Veterans Affairs Medical Center - San Diego
		Samuel B Ho, MD	Ph: 858-642-3280
			Email: samuel.ho2@va.gov
Colorado
	Denver
	Veterans Affairs Medical Center - Denver
		Dennis J Ahnen, MD	Ph: 303-399-8020 Ext.3127
			Email: dennis.ahnen@va.gov
Florida
	Gainesville
	Veterans Affairs Medical Center - Gainesville
		Shahnaz Sultan, MD	Ph: 352-376-1611 Ext.6574
			Email: shahnaz.sultan@va.gov
	Miami
	Veterans Affairs Medical Center - Miami
		Paul A Feldman, MD	Ph: 305-575-7000 Ext.3162
			Email: paul.feldman@va.gov
Hawaii
	Honolulu
	VA Pacific Islands Health Care System, Honolulu, HI
		Fernando V Ona, MD	Ph: 808-433-0078
			Email: fernando.ona@va.gov
Illinois
	Chicago
	Veterans Affairs Medical Center - Chicago Westside Hospital
		Lyn Sue Kahng, MD	Ph: 312-569-6193
			Email: lynsue.kahng@va.gov
Indiana
	Indianapolis
	Veterans Affairs Medical Center - Indianapolis
		Thomas F Imperiale, MD	Ph: 317-988-2223
			Email: thomas.imperiale@va.gov
Maryland
	Baltimore
	Veterans Affairs Medical Center - Baltimore
		Erik von Rosenvinge, MD	Ph: 410-605-7000 Ext.5260
			Email: erik.vonrosenvinge@va.gov
Michigan
	Ann Arbor
	Veterans Affairs Medical Center - Ann Arbor
		Philip Schoenfeld, MD	Ph: 734-845-5795
			Email: philip.schoenfeld@va.gov
	Detroit
	Veterans Affairs Medical Center - Detroit
		Fadi Antaki, MD	Ph: 313-576-3389
			Email: fadi.antaki@va.gov
Minnesota
	Minneapolis
	Veterans Affairs Medical Center - Minneapolis
		Aasma Shaukat, MD	Ph: 612-467-4100
			Email: aasma.shaukat@va.gov
Missouri
	Kansas City
	Veterans Affairs Medical Center - Kansas City
		Sharma Prateek, MD	Ph: 818-861-4711 Ext.56737
			Email: prateek.sharma@va.gov
	St Louis
	St. Louis VA Medical Center John Cochran Division, St. Louis, MO
		Jill E Elwing, MD	Ph: 314-289-6434
			Email: jill.elwing@va.gov
New Jersey
	East Orange
	Veterans Affairs Medical Center - East Orange
		Isabel Rellosa, MD	Ph: 973-676-1000 Ext.2085
			Email: isabel.rellosa@va.gov
New York
	Northport
	Veterans Affairs Medical Center - Northport
		Robert D Shaw, MD	Ph: 631-261-4400 Ext.2832
			Email: robert.shaw3@va.gov
North Carolina
	Durham
	Veterans Affairs Medical Center - Durham
		Deborah A Fisher, MD	Ph: 919-286-2287
			Email: deborah.fisher3@va.gov
Ohio
	Cleveland
	Veterans Affairs Medical Center - Cleveland
		Katarina B Greer, MD	Ph: 216-791-3800 Ext.4057
			Email: katarina.greer@va.gov
Oklahoma
	Oklahoma City
	Oklahoma City VA Medical Center, Oklahoma City, OK
		William M Tierney, MD	Ph: 405-456-1000
			Email: william.tierney@va.gov
Texas
	Dallas
	Veterans Affairs Medical Center - Dallas
		William V Harford, MD	Ph: 214-857-4132
			Email: william.harford@va.gov
	Houston
	Veterans Affairs Medical Center - Houston
		Rhonda A Cole, MD	Ph: 713-794-7274
			Email: rhonda.cole@va.gov
Utah
	Salt Lake City
	Veterans Affairs Medical Center - Salt Lake City
		Mae F Go, MD	Ph: 801-582-1565 Ext.44833
			Email: mae.go@va.gov
Vermont
	White River Junction
	White River Junction VA Medical Center and Regional Office, White River Junction, VT
		Heiko Pohl, MD	Ph: 802-295-9363 Ext.5595
			Email: Heiko.Pohl@va.gov
Virginia
	Richmond
	Hunter Holmes McGuire VA Medical Center, Richmond, VA
		Juan Diego Baltodano, MD	Ph: 804-675-5021
			Email: juan.baltodano@va.gov
Washington
	Seattle
	Veterans Affairs Medical Center - Seattle
		Jason A Dominitz, MD MHS	Ph: 206-764-2285
			Email: jason.dominitz@va.gov
		Andrew Kaz, MD	Ph: (206) 764-2285
			Email: andrew.kaz@va.gov
		Jason A. Dominitz, MD MHS	Study Chair
West Virginia
	Clarksburg
	Veterans Affairs Medical Center - Clarksburg
		Riaz Cassim, MD	Ph: 304-623-7617
			Email: riaz.cassim@va.gov
Wisconsin
	Madison
	Veterans Affairs Medical Center - Madison
		Adnan Said, MD	Ph: 608-213-4070 Ext.17002
			Email: adnan.said@va.gov

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01239082
Information obtained from ClinicalTrials.gov on December 30, 2012

Back to Top