About The ECLIPSE Trial
Trial Name: Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode
ClinicalTrials.gov ID: NCT04136002
Sponsor: Guardant Health Inc
Completion Date (Estimated): January 2024
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Positive Results Show Blood-Based Screening Test Detected Colorectal Cancer
The test’s sensitivity in distinguishing colorectal cancer, in combination with real-world adherence, showed its ability to detect cancer at a curable stage.
Positive results from the ECLIPSE (NCT04136002) study, that evaluated the effectiveness of Shield blood test to detect colorectal cancer (CRC), was published in the March 14 issue of the New England Journal of Medicine, according to Guardant Health.
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“Colorectal cancer is highly treatable if caught in the early stages, yet more than 50 million people in the [United States] are still not completing their recommended screening with the methods available today,” said Chris Evans, BS, president of the Colon Cancer Coalition, in a press release. “This publication gets us one step closer to having an additional option to offer patients—one that is both convenient and accessible—and will help us close the screening gap.”
The American Cancer Society reported that an estimate of 150,000 individuals or more will be diagnosed with CRC this year. The study authors noted that more than 75% of individuals that die from CRC did not receive current recommended screening, which mitigates early detection. If found at an early stage, the 5-year survival rate for CRC is 91%, compared to 13% if the cancer has already spread among the body, according to study authors.
“More than 3 out of 4 Americans who die from colorectal cancer are not up to date with their recommended screening, highlighting the need for a more convenient and less invasive screening method that can overcome barriers associated with traditional options,” said Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and professor of Medicine at Harvard Medical School, in a press release. “The ECLIPSE study results published today support the use of a blood test as a screening option that could help overcome these barriers and improve CRC screening rates."
The ECLIPSE study, standing for Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Episode, was reported to be one of the largest studies in its field, including more than 20,000 individuals. The study authors noted that the registration study aimed to compare the functioning of Shield—a test that detects CRC signals in the bloodstream through the shed of tumors—to a screening colonoscopy, in average-risk individuals aged 45 to 84 years old. The study was reported to include 200 clinical trial sites that were in rural and urban communities in 34 states. The study data included 12% Black, 13% Hispanic and 7% Asian American populations, according to study authors.
The following results were published and highlighted in the New England Journal of Medicine, that displayed an 83% sensitivity in detecting individuals with CRC and 88% sensitivity in detecting pathology confirmed stages I-III. The study authors noted that 100% of sensitivity was demonstrated in stages II, III, and IV, as 65% for pathology-confirmed Stage I and 55% for clinical Stage I.
“The results of the study are a promising step toward developing more convenient tools to detect colorectal cancer early while it is more easily treated,” said William M. Grady, MD, a gastroenterologist at Fred Hutchinson Cancer Center, in a press release. “The test, which has an accuracy rate for colon cancer detection similar to stool tests used for early detection of cancer, could offer an alternative for patients who may otherwise decline current screening options."
Shield was previously submitted for an FDA premarket approval application, which included positive findings from the study. The study authors noted that a recent study revealed that the test’s sensitivity in distinguishing CRC, in combination with real-world adherence, made Shield more beneficial to detect CRCs at a curable stage, compared to other screening methods.
“We believe the publication of the ECLIPSE study in the New England Journal of Medicine, one of the world’s leading medical journals, is an endorsement of the quality of our clinical data and the potential value of the Shield test. We are confident that offering an accurate blood test has the potential to significantly reduce preventable colorectal cancer deaths,” said Talasaz, in a press release.
Reference
Guardant Health ECLIPSE Study Data Demonstrating Efficacy of Shield Blood-based Test for Colorectal Cancer Screening to be Published in The New England Journal of Medicine. Guardant. News release. March 13, 2024. Accessed March 21, 2024. https://investors.guardanthealth.com/press-releases/press-releases/2024/Guardant-Health-ECLIPSE-Study-Data-Demonstrating-Efficacy-of-Shield-Blood-based-Test-for-Colorectal-Cancer-Screening-to-be-Published-in-The-New-England-Journal-of-Medicine/default.aspx.
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