Evidence map›Paper›PMID 36948424›Full record

Trial reportGastroenterology2023

Randomized Trial of Facilitated Adherence to Screening Colonoscopy vs Sequential Fecal-Based Blood Test.

Ann G Zauber, Sidney J Winawer, Michael J O'Brien, Glenn M Mills, John I Allen, Andrew D Feld, Paul A Jordan, Martin Fleisher, Irene Orlow, Reinier G S Meester and 17 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Gastroenterology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00102011 (Colonoscopy Screening Trial), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
3.9field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00102011 phase3completednot on this map

Colonoscopy Screening Trial

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2000 to 2026Enrolled4,952ConditionsColorectal CancerArmsannual screening, fecal occult blood test, screening colonoscopy, standard follow-up care
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. DDS Profile: Sidney J. Winawer.Digestive diseases and sciences · 2025
    Article
  5. Review
  6. Optimal Approach to Colorectal Cancer Screening.Gastroenterology & hepatology · 2025
    Article
  7. [New methods for colorectal cancer screening].Innere Medizin (Heidelberg, Germany) · 2024
    Article
  8. Article
  9. Screening of colorectal cancer: Methods and strategies.World journal of clinical oncology · 2024
    Article
  10. Commentary: Liquid Biopsy for Average-Risk Colorectal Cancer Screening.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2024
    Article
  11. Thoughts during my last colonoscopy.iGIE : innovation, investigation and insights · 2024
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 14 institutions in 2 countries.

Ann G ZauberDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York. Electronic address: zaubera@mskcc.org.
Sidney J WinawerGastroenterology, Hepatology, and Nutrition Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
Michael J O'BrienDepartment of Pathology and Laboratory Medicine, Boston University Medical Center, Boston, Massachusetts.
Glenn M MillsFeist-Weiller Cancer Center, Shreveport, Louisiana.
John I AllenDivision of Gastroenterology and Hepatology, Department of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan.
Andrew D FeldDepartment of Gastroenterology, Kaiser Permanente Washington, Seattle, Washington.
Paul A JordanDepartment of Medicine, Louisiana State University Health, Shreveport, Louisiana.
Martin FleisherDepartment of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
Irene OrlowDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
Reinier G S MeesterDepartment of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands.
Iris Lansdorp-VogelaarDepartment of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands.
Carolyn M RutterBiostatistics Program, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Hutchinson Institute for Cancer Outcomes Research, Seattle, Washington.
Amy B KnudsenInstitute for Technology Assessment, Massachusetts General Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.
Margaret MandelsonCancer Institute Virginia Mason Medical Center, Seattle, Washington.
Aasma ShaukatDivision of Gastroenterology, Department of Medicine Environmental Health Sciences, University of Minnesota School of Public Health, Minneapolis, Minnesota; Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota; Division of Gastroenterology, Department of Medicine, NYU Langone Health, New York, New York.
Robin B MendelsohnGastroenterology, Hepatology, and Nutrition Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
Anne I HahnDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
Stephanie M LobaughDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
Brittany Soto PalmerCVS Health, Woonsocket, Rhode Island.
Victoria SerranoRegeneron Pharmaceuticals, Tarrytown, New York.
Julie R KumarInvestigative Initiative Trials and Compassionate Use Studies, Novartis, East Hanover, New Jersey.
Sara E FischerDepartment of Government, Georgetown University, Washington, District of Columbia.
Jennifer C ChenDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
Sharon Bayuga-MillerDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
Deborah KukFlatiron Health, New York, New York.
Kelli O'ConnellDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
Timothy R ChurchDivision of Gastroenterology, Department of Medicine Environmental Health Sciences, University of Minnesota School of Public Health, Minneapolis, Minnesota; Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota.
Memorial Sloan Kettering Cancer Center · USErasmus MC · NLUniversity of Minnesota · USBoston University · USCVS Health (United States) · USFlatiron Health (United States) · USFred Hutch Cancer Center · USGeorgetown University · USHarvard University · USKaiser Permanente · USLouisiana State University · USRegeneron (United States) · USUniversity of Michigan · USVirginia Mason Medical Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
SCREENING COLONOSCOPY FEASIBILITY TRIALR01CA079572 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI ZAUBER, ANN GRAHAM · 1999 to 2011
$9.9M
Comparative Modeling of Effective Policies for Colorectal Cancer ControlU01CA253913 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI RUTTER, CAROLYN M, ZAUBER, ANN GRAHAM · 2020 to 2025
$6.5M
Comparative Modeling of Colorectal Cancer: Informing Health Policies and Prioritizing Future ResearchU01CA199335 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI KUNTZ, KAREN M, LANSDORP-VOGELAAR, IRIS · 2015 to 2019
$5.5M
NCI NIH HHS P30 CA008748NCI NIH HHS R01 CA079572NCI NIH HHS U01 CA199335NCI NIH HHS U01 CA253913
6 · The paper itself

Abstract

BACKGROUND &

aimsColorectal cancer (CRC) screening guidelines include screening colonoscopy and sequential high-sensitivity fecal occult blood testing (HSgFOBT), with expectation of similar effectiveness based on the assumption of similar high adherence. However, adherence to screening colonoscopy compared with sequential HSgFOBT has not been reported. In this randomized clinical trial, we assessed adherence and pathology findings for a single screening colonoscopy vs sequential and nonsequential HSgFOBTs.

methodsParticipants aged 40-69 years were enrolled at 3 centers representing different clinical settings. Participants were randomized into a single screening colonoscopy arm vs sequential HSgFOBT arm composed of 4-7 rounds. Initial adherence to screening colonoscopy and sequential adherence to HSgFOBT, follow-up colonoscopy for positive HSgFOBT tests, crossover to colonoscopy, and detection of advanced neoplasia or large serrated lesions (ADN-SERs) were measured.

resultsThere were 3523 participants included in the trial; 1761 and 1762 participants were randomized to the screening colonoscopy and HSgFOBT arms, respectively. Adherence was 1473 (83.6%) for the screening colonoscopy arm vs 1288 (73.1%) for the HSgFOBT arm after 1 round (relative risk [RR], 1.14; 95% CI, 1.10-1.19; P ≤ .001), but only 674 (38.3%) over 4 sequential HSgFOBT rounds (RR, 2.19; 95% CI, 2.05-2.33). Overall adherence to any screening increased to 1558 (88.5%) in the screening colonoscopy arm during the entire study period and 1493 (84.7%) in the HSgFOBT arm (RR, 1.04; 95% CI, 1.02-1.07). Four hundred thirty-six participants (24.7%) crossed over to screening colonoscopy during the first 4 rounds. ADN-SERs were detected in 121 of the 1473 participants (8.2%) in the colonoscopy arm who were adherent to protocol in the first 12 months of the study, whereas detection of ADN-SERs among those who were not sequentially adherent (n = 709) to HSgFOBT was subpar (0.6%) (RR, 14.72; 95% CI, 5.46-39.67) compared with those who were sequentially adherent (3.3%) (n = 647) (RR, 2.52; 95% CI, 1.61-3.98) to HSgFOBT in the first 4 rounds. When including colonoscopies from HSgFOBT patients who were never positive yet crossed over (n = 1483), 5.5% of ADN-SERs were detected (RR, 1.50; 95% CI, 1.15-1.96) in the first 4 rounds.

conclusionsObserved adherence to sequential rounds of HSgFOBT was suboptimal compared with a single screening colonoscopy. Detection of ADN-SERs was inferior when nonsequential HSgFOBT adherence was compared with sequential adherence. However, the greatest number of ADN-SERs was detected among those who crossed over to colonoscopy and opted to receive a colonoscopy. The effectiveness of an HSgFOBT screening program may be enhanced if crossover to screening colonoscopy is permitted. CLINICALTRIALS: gov, Number: NCT00102011.

Indexed as

Colorectal NeoplasmsOccult BloodColonoscopyEarly Detection of CancerHematologic TestsHumansMass ScreeningColonoscopyColorectal Cancer ScreeningCrossover ColonoscopyFecal Occult Blood TestScreening Guidelines

Identifiers

PMID36948424
PMCPMC10330012
OpenAlexW4328136076

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.