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Grant Details

Grant Number: 5R01CA213645-06 Interpret this number
Primary Investigator: Doubeni, Chyke
Organization: Mayo Clinic Rochester
Project Title: Effectiveness of Screening for Colorectal Cancer in Average Risk Adults: Colonoscopy Vs Fit
Fiscal Year: 2021


PROJECT SUMMARY: Cancers of the colon and rectum are the second leading cause of cancer deaths in the United States, but are potentially preventable through early detection of invasive or precancerous lesions. Of the currently recommended tests for screening average risk people, colonoscopy is the most commonly used in the United States, but stool-based tests such as fecal immunochemical tests (FIT), are the most commonly used globally. However, there is currently no strong evidence to inform highly consequential decisions on these competing screening strategies, which contributes to conflicting recommendations from policy groups including a Canadian task force recommendation against using colonoscopy for routine screening. Microsimulation studies report that FIT and colonoscopy can achieve similar overall lifetime effectiveness, but are based on assumptions of efficacy and adherence to regular screening that are not attainable in real practice. An added challenge is the paucity of well-developed statistical approaches that can account for varying levels of adherence, patterns of use such as cross-overs, and time-dependent confounding when estimating the effectiveness of colorectal cancer (CRC) screening tests. Our proposed series of studies aim to: 1) estimate the effectiveness of FIT in reducing the risk of dying from CRC when compared with no screening, and 2) compare the effectiveness of FIT in reducing the risk of dying from CRC relative to screening colonoscopy. We will also assess for potential effect modification by race/ethnicity, sex, and socioeconomic status. We will use a nested case-control design with about 2000 cases and 8000 controls between 2014 and 2018 in a historical cohort of about 2 million screening-eligible people receiving care at Kaiser Permanente Northern and Southern California. Cases for the study will be men and women who were 52-89 years old at the date of death from CRC, each matched within health plan to four randomly selected controls based on age, sex, enrollment history, and geographic region. As secondary methodological aims, we will: 1) apply novel statistical methods to estimate FIT-colonoscopy comparative effectiveness in varying real-life screening patterns including imperfect adherence and crossover from FIT to colonoscopy; and 2) assess the use of a case-cohort design to inform future studies. As an exploratory aim, we will characterize the resources required to screen with FIT or colonoscopy as inputs for future microsimulation studies. Our study sites provide the full continuum of cancer care ranging from screening through end of life, and provide access to information on CRC screening that can be linked to diagnosis and cause-specific mortality data on large numbers of people. We will identify receipt of screening colonoscopy and screening FIT in the 10-year window prior to the reference date, differentiating screening from diagnostic procedures with selected chart audits to confirm colonoscopy screening indications. This will be the first observational study to address these critical scientific, clinical, and policy questions. The project will be implemented by an experienced team of high-impact scientists.


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Association between Improved Colorectal Screening and Racial Disparities.
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Development and evaluation of safety and effectiveness of novel cancer screening tests for routine clinical use with applications to multicancer detection technologies.
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Rising Early-onset Colorectal Cancer Incidence Is Not an Artifact of Increased Screening Colonoscopy Use in a Large, Diverse Healthcare System.
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Program Components and Results From an Organized Colorectal Cancer Screening Program Using Annual Fecal Immunochemical Testing.
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The effect of using fecal testing after a negative sigmoidoscopy on the risk of death from colorectal cancer.
Authors: Doubeni C.A. , Corley D.A. , Jensen C.D. , Schottinger J.E. , Lee J.K. , Ghai N.R. , Levin T.R. , Zhao W.K. , Saia C.A. , Wainwright J.V. , et al. .
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Cancer Screening During the Coronavirus Disease-2019 Pandemic: A Perspective From the National Cancer Institute's PROSPR Consortium.
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Framework and Strategies to Eliminate Disparities in Colorectal Cancer Screening Outcomes.
Authors: Doubeni C.A. , Selby K. , Gupta S. .
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PMID: 33208026
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An RCT of Fecal Immunochemical Test Colorectal Cancer Screening in Veterans Without Recent Primary Care.
Authors: Goldshore M.A. , Mehta S.J. , Fletcher W. , Tzanis G. , Doubeni C.A. , Paulson E.C. .
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Lung Cancer Screening Guidelines Implementation in Primary Care: A Call to Action.
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Long-term Risk of Colorectal Cancer and Related Death After Adenoma Removal in a Large, Community-based Population.
Authors: Lee J.K. , Jensen C.D. , Levin T.R. , Doubeni C.A. , Zauber A.G. , Chubak J. , Kamineni A.S. , Schottinger J.E. , Ghai N.R. , Udaltsova N. , et al. .
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PMID: 31589872
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Causes of Socioeconomic Disparities in Colorectal Cancer and Intervention Framework and Strategies.
Authors: Carethers J.M. , Doubeni C.A. .
Source: Gastroenterology, 2020 Jan; 158(2), p. 354-367.
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Effect of Sex, Age, and Positivity Threshold on Fecal Immunochemical Test Accuracy: A Systematic Review and Meta-analysis.
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Early-onset colorectal cancer: What reported statistics can and cannot tell us and their implications.
Authors: Doubeni C.A. .
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Effect of Sequential or Active Choice for Colorectal Cancer Screening Outreach: A Randomized Clinical Trial.
Authors: Mehta S.J. , Induru V. , Santos D. , Reitz C. , McAuliffe T. , Orellana C. , Volpp K.G. , Asch D.A. , Doubeni C.A. .
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PMID: 31469393
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Screening flexible sigmoidoscopy versus colonoscopy for reduction of colorectal cancer mortality.
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PMID: 31152198
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Effect of Financial Incentives on Patient Use of Mailed Colorectal Cancer Screening Tests: A Randomized Clinical Trial.
Authors: Mehta S.J. , Pepe R.S. , Gabler N.B. , Kanneganti M. , Reitz C. , Saia C. , Teel J. , Asch D.A. , Volpp K.G. , Doubeni C.A. .
Source: JAMA network open, 2019-03-01; 2(3), p. e191156.
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PMID: 30901053
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Modifiable Failures in the Colorectal Cancer Screening Process and Their Association With Risk of Death.
Authors: Doubeni C.A. , Fedewa S.A. , Levin T.R. , Jensen C.D. , Saia C. , Zebrowski A.M. , Quinn V.P. , Rendle K.A. , Zauber A.G. , Becerra-Culqui T.A. , et al. .
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PMID: 30268788
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Accurate Identification of Colonoscopy Quality and Polyp Findings Using Natural Language Processing.
Authors: Lee J.K. , Jensen C.D. , Levin T.R. , Zauber A.G. , Doubeni C.A. , Zhao W.K. , Corley D.A. .
Source: Journal of clinical gastroenterology, 2019 Jan; 53(1), p. e25-e30.
PMID: 28906424
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A Randomized Controlled Trial of Opt-in Versus Opt-Out Colorectal Cancer Screening Outreach.
Authors: Mehta S.J. , Khan T. , Guerra C. , Reitz C. , McAuliffe T. , Volpp K.G. , Asch D.A. , Doubeni C.A. .
Source: The American journal of gastroenterology, 2018 Dec; 113(12), p. 1848-1854.
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In Screening for Colorectal Cancer, Is the FIT Right for the Right Side of the Colon?
Authors: Doubeni C.A. , Levin T.R. .
Source: Annals of internal medicine, 2018-11-06; 169(9), p. 650-651.
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PMID: 30285038
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Effects of Organized Colorectal Cancer Screening on Cancer Incidence and Mortality in a Large Community-Based Population.
Authors: Levin T.R. , Corley D.A. , Jensen C.D. , Schottinger J.E. , Quinn V.P. , Zauber A.G. , Lee J.K. , Zhao W.K. , Udaltsova N. , Ghai N.R. , et al. .
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PMID: 30031768
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When Should Guidelines Change? A Clarion Call for Evidence Regarding the Benefits and Risks of Screening for Colorectal Cancer at Earlier Ages.
Authors: Corley D.A. , Peek R.M. .
Source: Gastroenterology, 2018 Oct; 155(4), p. 947-949.
EPub date: 2018-09-04.
PMID: 30193780
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Colorectal Cancer Screening Participation Among Asian Americans Overall and Subgroups in an Integrated Health Care Setting with Organized Screening.
Authors: Ghai N.R. , Jensen C.D. , Corley D.A. , Doubeni C.A. , Schottinger J.E. , Zauber A.G. , Lee A.T. , Contreras R. , Levin T.R. , Lee J.K. , et al. .
Source: Clinical and translational gastroenterology, 2018-09-21; 9(9), p. 186.
EPub date: 2018-09-21.
PMID: 30242160
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Timely follow-up of positive cancer screening results: A systematic review and recommendations from the PROSPR Consortium.
Authors: Doubeni C.A. , Gabler N.B. , Wheeler C.M. , McCarthy A.M. , Castle P.E. , Halm E.A. , Schnall M.D. , Skinner C.S. , Tosteson A.N.A. , Weaver D.L. , et al. .
Source: CA: a cancer journal for clinicians, 2018 May; 68(3), p. 199-216.
EPub date: 2018-03-30.
PMID: 29603147
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Effectiveness of screening colonoscopy in reducing the risk of death from right and left colon cancer: a large community-based study.
Authors: Doubeni C.A. , Corley D.A. , Quinn V.P. , Jensen C.D. , Zauber A.G. , Goodman M. , Johnson J.R. , Mehta S.J. , Becerra T.A. , Zhao W.K. , et al. .
Source: Gut, 2018 Feb; 67(2), p. 291-298.
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PMID: 27733426
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Colorectal Cancer Screening Initiation After Age 50 Years in an Organized Program.
Authors: Fedewa S.A. , Corley D.A. , Jensen C.D. , Zhao W. , Goodman M. , Jemal A. , Ward K.C. , Levin T.R. , Doubeni C.A. .
Source: American journal of preventive medicine, 2017 Sep; 53(3), p. 335-344.
EPub date: 2017-04-17.
PMID: 28427954
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Racial and Ethnic Disparities in Interval Colorectal Cancer Incidence: A Population-Based Cohort Study.
Authors: Fedewa S.A. , Flanders W.D. , Ward K.C. , Lin C.C. , Jemal A. , Goding Sauer A. , Doubeni C.A. , Goodman M. .
Source: Annals of internal medicine, 2017-06-20; 166(12), p. 857-866.
EPub date: 2017-05-23.
PMID: 28531909
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Colorectal Cancer Screening Comparative Effectiveness-Clinical Trials Are Not Always the Answer.
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Source: JAMA internal medicine, 2017-01-01; 177(1), p. 143-144.
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