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Gastrointestinal (GI) diagnostic studies are pivotal in confirming, ruling out, diagnosing, or staging various diseases, including cancers. Following diagnosis, allocating time for discussions with the patient and providing informational resources is crucial. Diagnostic assessments of the GI tract often occur in outpatient settings like endoscopy suites or GI labs. Preparation for these tests may include dietary restrictions, fasting, liquid bowel preparations, laxatives, enemas, and the...
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Evaluation of Colorectal Cancer Risk and Prevalence by Stool DNA Integrity Detection
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A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening.

Daniel C Chung1, Darrell M Gray1, Harminder Singh1

  • 1From the Division of Gastroenterology and Cancer Center, Massachusetts General Hospital and Harvard Medical School, Boston (D.C.C.); Gray Area Strategies, Owings Mills, MD (D.M.G.); the Association of Black Gastroenterologists and Hepatologists, New York (D.M.G.); the Departments of Internal Medicine and Community Health Sciences, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba and Paul Albrechtsen Research Institute CancerCare Manitoba, Winnipeg, Canada (H.S.); the Divisions of Public Health Sciences (R.B.I., W.M.G.), Clinical Research (R.B.I.), and Translational Science and Therapeutics (W.M.G.), Fred Hutchinson Cancer Center, and the Division of Gastroenterology, University of Washington School of Medicine (R.B.I., W.M.G.) - both in Seattle; Guardant Health, Palo Alto (V.M.R., C.E., S.H., D.I.C., A.T.), and the University of California, San Diego, La Jolla (S.G.) - both in California; the Department of Pathology, Michigan Medicine, Ann Arbor (J.K.G.); and the Divisions of Oncology, Gastroenterology, and Hepatology, Mayo Clinic, Mayo Comprehensive Cancer Center and Mayo Alix School of Medicine, Rochester, MN (F.A.S.).

The New England Journal of Medicine
|March 13, 2024
PubMed
Summary
This summary is machine-generated.

A new blood test shows promise for colorectal cancer screening, detecting 83% of cancers and 90% of advanced neoplasia. This cell-free DNA (cfDNA) test could improve adherence and early detection rates for this common cancer.

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Area of Science:

  • Oncology
  • Molecular Diagnostics
  • Public Health

Background:

  • Colorectal cancer is a leading cause of cancer death in the U.S.
  • Low screening rates persist despite available tests.
  • Blood-based tests offer potential to improve screening adherence and early detection.

Purpose of the Study:

  • To evaluate the performance of a cell-free DNA (cfDNA) blood test for colorectal cancer screening.
  • To determine sensitivity for colorectal cancer and specificity for advanced neoplasia.
  • To assess sensitivity for detecting advanced precancerous lesions.

Main Methods:

  • A clinical validation study involving 10,258 participants eligible for colorectal cancer screening.
  • Comparison of cfDNA blood test results against screening colonoscopy findings.
  • Analysis of coprimary outcomes: sensitivity for colorectal cancer and specificity for advanced neoplasia.

Main Results:

  • The cfDNA test demonstrated 83.1% sensitivity for detecting colorectal cancer.
  • Specificity for advanced neoplasia was 89.6%.
  • Sensitivity for advanced precancerous lesions was 13.2%.

Conclusions:

  • The cfDNA blood test achieved 83% sensitivity for colorectal cancer and 90% specificity for advanced neoplasia in an average-risk population.
  • The test has the potential to enhance colorectal cancer screening adherence and reduce mortality.
  • Further validation supports the role of cfDNA testing in colorectal cancer screening strategies.