ArticleGut2023
An efficient strategy for evaluating new non-invasive screening tests for colorectal cancer: the guiding principles.
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Article in Gut, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.
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21citing papers in PubMed, 2 pooled it
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Who cites it
21 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Single-round performance of colorectal cancer screening programs: a network meta-analysis of randomized clinical trials.BMC medicine · 2025Pooled it
- Where do we stand with screening for colorectal cancer and advanced adenoma based on serum protein biomarkers? A systematic review.Molecular oncology · 2024Pooled it
- Discovery and characterization of Christensenella hongkongensis as a novel bacterium in the adenoma-carcinoma progression.Journal of translational medicine · 2026Article
- Quantitative evaluation of China's smart aging healthcare policy under the background of silver economy development: based on PMC model.Frontiers in public health · 2026Article
- Could artificial intelligence-powered colonoscopies change the future of colorectal cancer screening?World journal of gastroenterology · 2025Review
- The burden of colorectal cancer attributable to high body mass index in China: findings from 1990 to 2021 and prediction to 2035.International journal of colorectal disease · 2025Article
- Evaluating New Non-invasive Screening Tests for Colorectal Cancer: An In-Depth International Perspective-Introduction to a Special Issue of Digestive Diseases and Sciences.Digestive diseases and sciences · 2025Article
- An Adjustable Positivity Threshold for Non-invasive Screening Tests for Colorectal Neoplasms Can Improve Screening Program Effectiveness and Feasibility.Digestive diseases and sciences · 2025Review
- FIT as a Comparator for Evaluating the Effectiveness of New Non-invasive CRC Screening Test.Digestive diseases and sciences · 2025Review
- Fecal Immunochemical Test Positivity Thresholds: An International Survey of Population-Based Screening Programs.Digestive diseases and sciences · 2025Review
- Colonoscopy Remains an Important Option for Primary Screening for Colorectal Cancer.Digestive diseases and sciences · 2025Review
- Modeling and the Use of Surrogate Endpoints: Is This a Valid Approach?Digestive diseases and sciences · 2025Article
- Application of the Colorectal Cancer (CRC) Screening Guiding Principles for Non-invasive Testing to Multi-target Stool DNA: A Case Study.Digestive diseases and sciences · 2025Review
- Developing a New Stool Test for Colorectal Cancer Screening, the multitargetFIT (mtFIT).Digestive diseases and sciences · 2025Article
- CD147-expressed small extracellular vesicles enhance the detection of colorectal neoplasia with fecal immunochemical test.ESMO gastrointestinal oncology · 2025Article
- Early Detection, Precision Treatment, Recurrence Monitoring: Liquid Biopsy Transforms Colorectal Cancer Therapy.Current cancer drug targets · 2025Review
- Plasma mutation profile of precursor lesions and colorectal cancer using the Oncomine Colon cfDNA Assay.BMC cancer · 2024Article
- Projected Impact and Cost-Effectiveness of Novel Molecular Blood-Based or Stool-Based Screening Tests for Colorectal Cancer.Annals of internal medicine · 2024Article
- Adenoma location, size, and morphology are risk factors for FOBT false-negative results in inpatients with advanced colorectal adenoma.Scientific reports · 2024Article
- Machine learning-based identification of colorectal advanced adenoma using clinical and laboratory data: a phase I exploratory study in accordance with updated World Endoscopy Organization guidelines for noninvasive colorectal cancer screening tests.Frontiers in oncology · 2024Article
Corrections and comments
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Authors and funding
48 authors.
Robert S Bresalier *Department of Gastroenterology, Hepatology, and Nutrition, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-9740-281X
Carlo Senore *Epidemiology and screening unit, Centro di Riferimento per l'Epidemiologia e la Prevenzione Oncologica in Piemonte, Turin, Italy.ORCID 0000-0003-1023-7477
Graeme P Young *Flinders Centre for Innovation in Cancer, Flinders University, Adelaide, South Australia, Australia graeme.young@flinders.edu.au.ORCID 0000-0001-9458-8383
James AllisonInternal Medicine/Division of Gastroenterology, University of California San Francisco (UCSF), San Francisco, California, USA.
Robert BenamouzigGastroenterology & Digestive Oncology Department, Hôpital Avicenne University Paris Nord La Sorbonne, Bobigny, France.
Sally BentonDepartment of Clinical Biochemistry and NHS Bowel Cancer Screening South of England Hub, Royal Surrey County Hospital, Guildford, Surrey, UK.
Patrick M M BossuytDepartment of Epidemiology & Data Science, Amsterdam Public Health, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.
Luis CaroCarrera de especialista de Endoscopia Digestiva, Institución GEDYT (Gastroenterologia diagnostico y terapéutica), Buenos Aires, Argentina.
Beatriz CarvalhoPathology, Netherlands Cancer Institute, Amsterdam, The Netherlands.ORCID 0000-0003-4903-399X
Han-Mo ChiuDepartment of Internal Medicine, College of Medicine, National Taiwan University Hospital, Taipei, Taiwan.ORCID 0000-0003-2786-8056
Veerle M H CoupéEpidemiology and Data Science, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
Willemijn de KlaverDepartment of Pathology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
Clasine Maria de KlerkDepartment of Gastroenterology and Hepatology C2-310, Amsterdam UMC University of Amsterdam, Amsterdam, The Netherlands.
Evelien DekkerDepartment of Gastroenterology and Hepatology C2-115, Amsterdam University Medical Centres, Duivendrecht, The Netherlands.ORCID 0000-0002-4363-0745
Sunil DolwaniDept of Gastroenterology, Division of Population Medicine, Cardiff University School of Medicine, Cardiff, UK.
Callum G FraserCentre for Research into Cancer Prevention and Screening, University of Dundee School of Medicine, Dundee, UK.ORCID 0000-0002-1333-7994
William GradyDivision of Translational Science and Therapeutics, Fred Hutchinson Cancer Center, Seattle, Washington, USA.ORCID 0000-0002-0129-7809
Lydia GuittetERI3 Cancers & Populations, Normandie University, UNICAEN, Caen, France.
Samir GuptaDepartment of Medicine, University of California San Diego, La Jolla, CA, USA.
Stephen P HalloranClinical Biochemistry, University of Surrey, Guildford, UK.
Ulrike HaugDivision of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology, Bremen, Germany.
Geir HoffDepartment of Research, Telemark Hospital, Skien, Norway.
Steven ItzkowitzDivision of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Tim KortleverGastroenterology and Hepatology, Amsterdam University Medical Centres, Duivendrecht, The Netherlands.ORCID 0000-0001-5416-9571
Anastasios KoulaouzidisDepartment of Clinical Research, University of Southern Denmark, Odense, Denmark.ORCID 0000-0002-2248-489X
Uri LadabaumDivision of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, California, USA.
Beatrice Lauby-SecretanSection of Evidence Synthesis and Classification, International Agency for Research on Cancer, Lyon, France.
Mārcis LejaInstitute of Clinical and Preventive Medicine, Faculty of Medicine, University of Latvia, Riga, Latvia.ORCID 0000-0002-0319-8855
Bernard LevinDivision of Cancer Prevention and Population Sciences, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Theodore Robert LevinGastroenterology, Kaiser Permanente Division of Research, Oakland, California, USA.ORCID 0000-0002-0842-2377
Finlay MacraeColorectal Medicine and Genetics, The University of Melbourne Department of Medicine Royal Melbourne Hospital, Parkville, Victoria, Australia.
Gerrit A MeijerPathology, Netherlands Cancer Institute, Amsterdam, The Netherlands.ORCID 0000-0003-0330-3130
Joshua MelsonHigh-Risk Clinic for Gastrointestinal Cancers, University of Arizona Cancer Center Division of Gastroenterology, Banner University, Tucson, Arizona, USA.
Colm O'MorainGastroenterology, Trinity College Dublin Faculty of Health Sciences, Dublin, Ireland.
Susan ParryNational Bowel Screening Programme, National Screening Unit, Te Whatu Ora Health New Zealand, Auckland, New Zealand.
Linda RabeneckDepartment of Medicine, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada.
David F RansohoffDepartment of Medicine, University of North Carolina, Chapel Hill, NC, USA.
Roque SáenzClínica Alemana de Santiago, Universidad del Desarrollo, Santiago de Chile, Chile.
Hiroshi SaitoDepartment of Gastroenterology, Aomori Prefectural Central Hospital, Aomori, Japan.
Silvia Sanduleanu-DascalescuGROW School for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands.
Robert E SchoenDepartments of Medicine and Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.ORCID 0000-0001-7153-2766
Kevin SelbyDepartment of ambulatory Care, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.
Harminder SinghInternal Medicine, University of Manitoba Max Rady College of Medicine, Winnipeg, Manitoba, Canada.ORCID 0000-0002-9354-2356
Robert J C SteeleSurgery and Oncology, University of Dundee, Dundee, UK.ORCID 0000-0003-4248-6785
Joseph J Y SungLee Kong Chian School of Medicine, Nanyang Technological University, Singapore.ORCID 0000-0003-3125-5199
Erin Leigh SymondsDepartment of Gastroenterology, Flinders Medical Centre, Adelaide, South Australia, Australia.ORCID 0000-0003-2451-0358
Sidney J WinawerDepartment of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
Members of the World Endoscopy Colorectal Cancer Screening New Test Evaluation Expert Working Group
Funding
X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4MGreat Lakes/New England Clinical Validation CenterU01CA086400 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI RICCIARDIELLO, LUIGI, SYNGAL, SAPNA · 2000 to 2025
$26.0MMulti-cancer early detection using cell-free DNA methylome analysisU01CA285010 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ROBERT S BRESALIER, Wenyuan Li · 2023 to 2026
$3.3MNCI NIH HHS P30 CA008748NCI NIH HHS U01 CA086400NCI NIH HHS U01 CA285010World Health Organization 001
Abstract
objectiveNew screening tests for colorectal cancer (CRC) are rapidly emerging. Conducting trials with mortality reduction as the end point supporting their adoption is challenging. We re-examined the principles underlying evaluation of new non-invasive tests in view of technological developments and identification of new biomarkers.
designA formal consensus approach involving a multidisciplinary expert panel revised eight previously established principles.
resultsTwelve newly stated principles emerged. Effectiveness of a new test can be evaluated by comparison with a proven comparator non-invasive test. The faecal immunochemical test is now considered the appropriate comparator, while colonoscopy remains the diagnostic standard. For a new test to be able to meet differing screening goals and regulatory requirements, flexibility to adjust its positivity threshold is desirable. A rigorous and efficient four-phased approach is proposed, commencing with small studies assessing the test's ability to discriminate between CRC and non-cancer states (
conclusionNew non-invasive tests can be efficiently evaluated by a rigorous phased comparative approach, generating data from unbiased populations that inform predictions of their health impact.
Indexed as
Colorectal NeoplasmsMass ScreeningColonoscopyEarly Detection of CancerFecesHumansOccult BloodProspective Studiescolorectal adenomascolorectal cancercolorectal cancer screening
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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.