TEST:

CELLSEARCH®

P1/2, N=37, Active, not recruiting, Weill Medical College of Cornell University | Recruiting --> Active, not recruiting | N=76 --> 37

CTC-negative status predicted longer OS and PFS, while CAM-L positivity at T1 was associated with improved outcomes, particularly in ICI-treated patients. Combined assessment of both biomarkers may directly inform therapeutic decision-making, through early detection of outcomes.

P=N/A, N=27, Completed, Institut Claudius Regaud | Active, not recruiting --> Completed | Trial completion date: Sep 2025 --> Jan 2026 | Trial primary completion date: Sep 2025 --> Jan 2026

These findings support the hypothesis that volatile anesthetics may reduce short-term recurrence risk and warrant larger, longer-term trials to validate oncological outcomes.

These results support the clinical utility of HER2 assessment on CTCs with both workflows and highlight the potential diagnostic value of label-free CTC enrichment combined with HER2 quantification. Further studies in larger cohorts should be conducted to validate our findings and investigate the clinical relevance of HER2-positive CTCs detected with the developed pipeline, particularly in the context of anti-HER2 therapies.

Our study shows that CTCs provide key information that would have been missed by ctDNA monitoring alone and extends CTC and cfDNA genomic profiling to patients with a broad range of CTC counts for blood-based monitoring of HER2 status and other clinically actionable targets for informing treatment decisions in metastatic disease.

Simulations predict transitioning high-risk patients (CTC/tdEV score >1.75) to second-line FOLFIRI at week 4 or 10 improves median survival from 15.1 months (12.8-18.4 CI) to 22.7 months (17.1-35.8 CI), and from 13.3 months (10.5-21.7 CI) to 23.3 months (17.8-31.2 CI), respectively...These findings suggest that tdEVs, alone or in combination with CTCs, may help optimize treatment timing and outcomes in mCRC. The integration of CTCs and tdEVs into clinical practice could offer a personalized, cost-effective, and more sustainable alternative to routine imaging in managing advanced colorectal cancer.

Notably, the brightfield imaging strategy eliminates the need for fluorescence microscopy, enabling cost-effective and rapid CTC detection. Together, these results validate the platform's clinical applicability for low-abundance CTC detection and highlight its potential for real-world liquid biopsy-based cancer monitoring.

This consensus offers practical guidance for clinical integration of CTCs and outlines strategic research priorities to unlock their full potential in precision oncology.

Importantly, we also demonstrated the feasibility of processing blood samples of up to 40 mL or 2 × 108 nucleated blood cells in 2.5 min. Overall, our new system provides the advantage of performing ultra-rapid enrichment of CTCs and upscaling the volume of blood that can be analyzed, which opens a new avenue for studies on CTC biology.

Peripheral CTCs isolated from patients with HGSC were predictors of a poor prognosis. The ovarian vein was found to be a rich source of disseminating CTC clusters in HGSC. Further studies are warranted to investigate the utility of CTCs as markers of neoadjuvant chemotherapy response as well as for longitudinal monitoring. Molecular analysis of CTCs in HGSCs reveals a potential role of the immune system in CTC-mediated haematogenous metastasis.

ILC shed more CTCs than NST, likely due to biological differences. While the ≥5 CTC/7.5mL threshold remained a valid prognostic marker for both, it was predictive of chemotherapy benefit in NST, but not ILC. These findings highlight differences in biomarker utility between ILC and NST, affecting both threshold relevance and treatment response.