VA Cooperative Studies Program (CSP)

Investigator Access

What's Available

Check with the study contact and publications for information on a public dataset, data archive, data enclave, or website where data might be available.

Available Documentation

Dates Data are Available

Access Criteria

Study Characteristics

Objectives

CSP #577 Main study: The primary objective is to determine if a strategy of screening colonoscopy decreases colorectal cancer (CRC) mortality over 10 years in average risk adults as compared to annual Fecal Immunochemical Test (FIT) screening.

CSP #577 Biorepository sub-study: To develop a biorepository of blood and tissue samples from participants of the main study, and to request access to participants’ electronic medical records and survey data. 

Era of Service

All

Population

Veterans aged 50-75 at average risk for CRC

Study Design

Multi-center, prospective, randomized, parallel-group trial

Intervention

• Colonoscopy
• FIT

Time Period

Main study: April 2012 – September 2028
Biorepository sub-study: February 2017 – September 2019

Setting

National

N

Main study: 50,126 participants
Biorepository sub-study: 10,000 participants

Response Rate

Unconfirmed

Recruitment Method

Screening is conducted through medical record review and provider referral for appropriate candidates. Recruitment is conducted in person, by telephone, or by mail after providers refer interested Veterans to the study.

Compensation

None

Data Collected

Main study:                

• Baseline measures (history of colonoscopy, Fecal Occult Blood Testing (FOBT), sigmoidoscopy, barium enema, CT colonography; family history; demographics; health care utilization; medications)
• Lifestyle measures (diet, vitamins, tobacco, alcohol, exercise, hormonal exposures (women))
• Colonoscopy Group:
                o   Colonoscopy quality measures (e.g. depth of insertion, quality of prep)  
                o   Colonoscopy findings 
                o   Colonoscopy complications 
                o   If positive, colonoscopy details and cancer details
• FIT Kit Group:   
               o    FIT sample  
               o    FIT results                                                                  
  
  

Biorepository sub-study:

•  Health survey
•  Blood specimens and tissue                                                 

Data Collection Methods

Unconfirmed

Funding Source

VA Cooperative Studies Program (CSP)

Investigators

Study Co-Chair: Jason A. Dominitz, MD, MHS

Study Co-Chair: Douglas J. Robertson, MD, MPH

Co-Investigator: Dawn Provenzale, MD, MS

Contact

Study Coordinator: Meaghan Larson, MPH; Meaghan.Larson@va.gov

Selected Publications

Dominitz JA, Robertson DJ, Ahnen DJ, Allison JE, Antonelli M, Boardman KD, Ciarleglio M, Del Curto BJ, Huang GD, Imperiale TF, Larson MF, Lieberman D, O'Connor T, O'Leary TJ, Peduzzi P, Provenzale D, Shaukat A, Sultan S, Voorhees A, Wallace R, Guarino PD. Colonoscopy vs. Fecal Immunochemical Test in Reducing Mortality from Colorectal Cancer (CONFIRM): Rationale for Study Design. Am J Gastroenterol. 2017 Nov;112(11):1736-1746

Imperiale TF, Ransohoff DF, Itzkowitz SH, Levin TR, Lavin P, Lidgard GP, Ahlquist DA, Berger BM. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014 Apr 3;370(14):1287-97. Doi: 10.1056/NEJMoa1311194. Epub 2014 Mar 9.

May FP, Yano EM, Provenzale D, Neil Steers W, Washington DL. The Association Between Primary Source of Healthcare Coverage and Colorectal Cancer Screening Among US Veterans. Dig Dis Sci. 2017 Aug;62(8):1923-1932. Doi: 10.1007/s10620-017-4607-x. Epub 2017 May 20.

More Information

• Study ClinicalTrials.gov site
• ClinicalTrials.gov identifier: NCT01239082
• Main study and sub-studies website
• Dimensions for VA summary (Requires an account to access outside the VA network. Dimensions for VA is a database that connects publications, grants, patents, clinical trials, and policy documents)