ECLIPSE
ECLIPSE: Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode
Phase observationalN = 7,861NCT04136002
- Population
- Persons eligible for colorectal cancer screening (clinical validation cohort of 10,258; 7,861 evaluable). Funded by Guardant Health.
- Design
- Clinical validation of a cell-free DNA blood-based test for colorectal cancer screening, with screening colonoscopy as the reference. The FDA summary of the pivotal study describes a multi-site, prospective, non-randomized, observational study in adults aged 45 to 84 at average risk who intended to undergo colonoscopy. Coprimary outcomes: sensitivity for colorectal cancer and specificity for advanced neoplasia; secondary outcome: sensitivity for advanced precancerous lesions. The validation cohort included 10,258 persons, of whom 7,861 met eligibility criteria and were evaluable.
- Primary endpoint
- Sensitivity for colorectal cancer, Specificity for advanced neoplasia
- Arms
- cfDNA blood-based test (experimental, n = 7,861): Blood draw tested for colorectal cancer-derived alterations in cell-free DNA; each result compared with screening colonoscopy and histopathology
- People
- Chung DC
Show the numbers
| Endpoint | Analysis | cfDNA blood-based test | Control | Effect |
|---|---|---|---|---|
| Sensitivity for colorectal cancerEvaluable cohort (7,861 participants)Proportion of participants with colorectal cancer on colonoscopy whose cfDNA test was positive | primaryChung 2024 | 83.1% (72.2–90.3%) | — | Diagnostic accuracy against colonoscopy; not an incidence or mortality outcome. The FDA summary of the pivotal study reports 54 of 65 cancers detected. |
| Sensitivity for stage I, II or III colorectal cancerEvaluable cohort (7,861 participants)Proportion of participants with stage I, II or III colorectal cancer on colonoscopy whose cfDNA test was positive | exploratoryChung 2024 | 87.5% (75.3–94.1%) | — | Stage I alone is not reported in the abstract. |
| Sensitivity for advanced precancerous lesionsEvaluable cohort (7,861 participants)Proportion of participants with an advanced precancerous lesion on colonoscopy whose cfDNA test was positive | primaryChung 2024 | 13.2% (11.3–15.3%) | — | — |
| Specificity for advanced neoplasiaEvaluable cohort (7,861 participants)Proportion of participants without colorectal cancer or advanced precancerous lesions on colonoscopy whose cfDNA test was negative | primaryChung 2024 | 89.6% (88.8–90.3%) | — | — |
| Specificity for negative colonoscopyEvaluable cohort (7,861 participants)Proportion of participants with no colorectal cancer, advanced precancerous lesion or nonadvanced precancerous lesion on colonoscopy whose cfDNA test was negative | exploratoryChung 2024 | 89.9% (89.0–90.7%) | — | — |
| Endpoint | Analysis | cfDNA blood-based test | Control | Effect |
|---|---|---|---|---|
| Sensitivity for colorectal cancerEvaluable cohort (7,861 participants)Proportion of participants with colorectal cancer on colonoscopy whose cfDNA test was positive | primaryChung 2024 | 83.1% (72.2–90.3%) | — | Diagnostic accuracy against colonoscopy; not an incidence or mortality outcome. The FDA summary of the pivotal study reports 54 of 65 cancers detected. |
| Sensitivity for stage I, II or III colorectal cancerEvaluable cohort (7,861 participants)Proportion of participants with stage I, II or III colorectal cancer on colonoscopy whose cfDNA test was positive | exploratoryChung 2024 | 87.5% (75.3–94.1%) | — | Stage I alone is not reported in the abstract. |
| Sensitivity for advanced precancerous lesionsEvaluable cohort (7,861 participants)Proportion of participants with an advanced precancerous lesion on colonoscopy whose cfDNA test was positive | primaryChung 2024 | 13.2% (11.3–15.3%) | — | — |
| Specificity for advanced neoplasiaEvaluable cohort (7,861 participants)Proportion of participants without colorectal cancer or advanced precancerous lesions on colonoscopy whose cfDNA test was negative | primaryChung 2024 | 89.6% (88.8–90.3%) | — | — |
| Specificity for negative colonoscopyEvaluable cohort (7,861 participants)Proportion of participants with no colorectal cancer, advanced precancerous lesion or nonadvanced precancerous lesion on colonoscopy whose cfDNA test was negative | exploratoryChung 2024 | 89.9% (89.0–90.7%) | — | — |