S224 Evaluating the Risk of Non-Colorectal Cancers in Individuals With a False Positive Blood-Based Colorectal Cancer Screening Test
Bibliographic record
Abstract
Introduction: Blood-based colorectal cancer screening tests provide a non-invasive colorectal cancer (CRC) screening modality that can be completed at any healthcare encounter. Data have shown that incorporating blood-based testing as a CRC screening option improves overall screening rates. With the introduction of these new tests, it is important to understand the implications of “false positive” result and if additional follow-up, beyond colonoscopy, is necessary to evaluate for non-colorectal cancer malignancies. To address this outstanding question, we report on the 1-year clinical outcomes of individuals enrolled and tested with Shield in the ECLIPSE study. Methods: ECLIPSE is a prospective, observational, multi-center study to evaluate a cfDNA blood-based CRC screening test (Shield) in average risk individuals, age 45-84. Enrolled individuals provided a blood sample prior to colonoscopy, followed by standard of care colonoscopy. Sensitivity and specificity of the blood-based test were determined as compared to the reference colonoscopy. Individuals were followed at 1- and 2-years post study enrollment date to evaluate for interval malignancies, both CRC and non-CRC. Results: ECLIPSE enrolled 22,877 average risk individuals. The final evaluable cohort was 7,861 persons. We previously reported that the study met its co-primary objectives; CRC sensitivity was 83% (95%CI 72 – 90%) and AN specificity was 90% (95%CI 89-90%). Test positivity rate was 11.4%. 698 individuals had a “false positive” cfDNA blood-based test (positive blood-based test and no colonoscopy finding of CRC or advanced precancerous lesion). 640/698 (92%) had 1 year of clinical follow-up and 0.8% (5/640) of them had a diagnosis of a non-colorectal cancer (95%CI 0.3 – 1.8) at 1 year of follow-up. In the 5,982 individuals with a “true negative” Shield result (negative cfDNA blood based test and colonoscopy that was negative for CRC or advanced precancerous lesion), 92% (5,502) had 1 year of clinical follow-up. 0.9% (51/5,502) had a non-colorectal cancer (95%CI 0.7-1.2) within 1 year of enrollment. There were no diagnoses of post-colonoscopy colorectal cancer identified during the 1-year follow-up period. Conclusion: Data from ECLIPSE demonstrate that the rate of non-colorectal malignancies does not differ in those who tested positive with the cfDNA blood-based test as compared to those who tested negative. Clinical follow-up is ongoing and will continue to gather 1- and 2-year cancer diagnosis in enrolled individuals.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.010 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.000 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".