A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening
- Study type
- Observational study
- Study name
- ECLIPSE
- Design
- Clinical validation (cohort) study assessing the performance of a cfDNA blood test in a population eligible for colorectal cancer screening, compared with screening colonoscopy
- Sample size
- 10,258 people were enrolled in the clinical validation cohort; 7861 met the eligibility criteria and were evaluable
- Source
- N Engl J Med · 2024
- Trial registration
- NCT04136002
In plain words
In this study, a blood test that looks at free DNA fragments in the blood was tested for bowel (colorectal) cancer screening in people at average risk and compared with colonoscopy. The test detected about 83% of bowel cancers but found only about 13% of advanced precancerous growths. The test was also positive in about 10% of people who did not have an advanced growth. So this test is not a full replacement for colonoscopy, and you should decide on the screening method with your doctor.
Key results
Treatment arms and regimens
The performance of a blood test based on circulating cell-free DNA (cfDNA) was measured against screening colonoscopy as the reference. (There is no drug intervention.)
Source of the regimen details: Abstract of the paper (diagnostic study; no drug or dose involved)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
People eligible for colorectal cancer screening (average-risk screening population). Of the 10,258 people in the clinical validation cohort, 7861 met the eligibility criteria and were evaluable. Details of inclusion and exclusion criteria are in the full text.
Endpoints
Co-primary endpoints: sensitivity for colorectal cancer and specificity for advanced neoplasia (colorectal cancer or advanced precancerous lesions), relative to screening colonoscopy.
Secondary endpoint: sensitivity for detecting advanced precancerous lesions.
Safety and side effects
The abstract reports no safety or adverse event data.
Clinical significance and place in guidelines
This study shows that a cfDNA blood test in an average-risk screening population can detect most colorectal cancers, but its sensitivity for advanced precancerous lesions is low (13.2%); its ability to prevent cancer through removal of polyps is therefore limited. According to the abstract, the place of this test in clinical guidelines and its regulatory approval status are unclear and should be checked in current guidelines. The results are relevant to decisions about its use in people who do not undergo screening or are not up to date, but the abstract provides no data on its effect on screening adherence or mortality.
Limitations
According to the abstract: the test's sensitivity for advanced precancerous lesions was low (13.2%), and about 10.4% of people without advanced neoplasia had a positive test. The abstract did not assess the test's effect on screening adherence, early detection in practice or mortality. The study was funded by Guardant Health, and several authors are affiliated with the company. Other limitations should be checked in the full text.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.