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VA Cooperative Studies Program (CSP)

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CSP #380 Main study & Follow-up studies (2)

Main study: 
CSP #380: Prospective Evaluation of Risk Factors for Large (≥ 1cm) Colonic Adenomas in Asymptomatic Subjects

Follow-up studies:
CSP #380-Sub-study: Longitudinal Analysis of VA CSP #380 Screening Colonoscopy
CSP #380-B: Genetic and Genomic Analysis of CSP#380 Tissues 

Data Sharing Statement 

What's available

  • Research data:  Individual participant data collected at baseline, 5-years, and 10-years, after deidentification. (SAS and text file formats)
  • Biospecimens: Coded DNA collected from 815 participants  

Available Documentation

Dates Data are Available 

Currently available, no end date 

Access Criteria

Investigators associated with VA or non-VA nonprofit, academic, or research institutions are invited to submit data and specimen requests to Kellie.Sims@va.gov.

Requests with IRB-approved protocols will be reviewed for scientific anad ethical merit. Requestor's must be fully compliant with VA data security, privacy, and human subjects requirements. This may involve implementation of access agreements (e.g., data use agreements). Allowable analyses include those designed to achieve the aims in the approved proposal submitted to the review committee.

Interested investigators are encouraged to contact Kellie.Sims@va.gov to arrange a consultation during study planning to discuss the proposed study and data/biospecimen access requirements. 

Study Characteristics 

Objectives

CSP #380 (Baseline): To determine risk factors for and the prevalence of advanced neoplasia and 10-year colorectal cancer outcomes among asymptomatic Veterans

CSP #380-Sub-study (5-year follow-up): To collect longitudinal data and specimens from the CSP #380 participants to understand the progression to colorectal cancer and determine the risk of advanced neoplasia and colorectal cancer at 10 years by baseline risk group

CSP #380-B (Biospecimens): To generate feasibility and pilot data regarding the use of colonic tissues and blood to create genomic profiles supportive of risk stratification

Era of Service

All

Population

Asymptomatic male and female Veterans ages 50-75 years who had screening colonoscopies at 13 VA medical centers between Feb 1994 and Jan 1997

Study Design

Prospective cohort

Time Period 

1994-1997 with 5-year and 10-year follow-up

Setting 

National

N

CSP #380 (Baseline): 3,121

CSP #380-Sub-study (5-year follow-up): 1,371

10-year follow-up: 3,121

CSP #380-B (Biospecimens):  815

Response Rate

17,732 patients were screened for enrollment. Among patients who met the eligibility criteria, 1,463 (31.4%) declined to participate, 3,196 (68.6%) eligible patients were enrolled, and of those enrolled, 3,121 (97.7%) had complete colonoscopy examinations to the cecum.

Recruitment Method

Patients from 13 VA medical centers were recruited; completed a clinic survey to determine eligibility; all participants provided written informed consent

Compensation

None

Data Collected

CSP #380 (Baseline): Colonoscopy results, including histology of all polyps removed, family history, medical history, lifestyle factors; blood and tissue samples from patients with large polyps and age-matched controls

CSP #380-Sub-study (5-year follow-up): Colonoscopy outcomes to determine recurrence rates and compare surveillance strategies

10-year follow-up: Medical outcomes including colorectal cancer, advanced neoplasia, and mortality. Colonoscopy outcomes stratified by baseline risk group to determine long term risk

CSP #380-B (Biospecimens): Genetic and genomic data from blood and tissue samples

Data Collection Methods

1) Colonoscopy and study questionnaires completed in-person

2) Retrieval of blood and tissue samples from VA Pathology labs; VA medical record abstractions and administrative datasets

Funding Source

VA Cooperative Studies Program (CSP)

Contact 

Kellie.Sims@va.gov

Selected Publications 

Lieberman DA, Weiss DG, Bond JH, Ahnen DJ, Garewal H, Harford WV, Provenzale D, Sontag S, Schnell T, Durbin TE, Nelson DB, Ewing SL, Triadafilopoulos G, Ramirez FC, Lee JG, Collins JF, Fennerty MB, Johnston TK, Corless CL, McQuaid KR, Sampliner RE, Morales TG, Fass R, Smith R, Maheshwari Y, Chejfec G. Use of colonoscopy to screen asymptomatic adults for colorectal cancer. NEJM. 2000 July 20;343(3):162-168.

Lieberman DA, Weiss DG, Harford WV, Ahnen DJ, Provenzale D, Sontag SJ, Schnell TG, Chejfec G, Campbell DR, Kidao J, Bond JH, Nelson DB, Triadafilopoulos G, Ramirez FC, Collins JF, Johnston TK, McQuaid KR, Garewal H, Robertson D.  Five-year colon surveillance after screening colonoscopy. Gastroenterology. 2007 Oct;133(4):1077-85.

Schreiner MA, Weiss DG, Lieberman DA. Proximal and large hyperplastic and nondysplastic serrated polyps detected by colonoscopy are associated with neoplasia. Gastroenterology. 2010 Nov;139(5):1497-502. Epub 2010 Jul 13.

Gellad ZF, Weiss DG, Ahnen DJ, Lieberman DA, Jackson GL, Provenzale D. Colonoscopy withdrawal time and risk of neoplasia at 5 years: Results from VA Cooperative Studies Program 380. Am J Gastroenterol. 2010 Aug;105(8):1746-52. Epub 2010 Mar 16. PMCID: PMC3729935

More Information 

Main study and follow-up studies website
Main study ClinicalTrials.gov site 
ClinicalTrials.gov Identifier: NCT00032344