TEST:

CELLSEARCH®

P2, N=97, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2026 --> Mar 2027

P1/2, N=52, Recruiting, Weill Medical College of Cornell University | Active, not recruiting --> Recruiting | N=37 --> 52

P1, N=16, Completed, Weill Medical College of Cornell University | Active, not recruiting --> Completed | Trial completion date: Oct 2026 --> Oct 2025

CTCs represent a powerful liquid biopsy tool with potential to revolutionize cancer diagnostics and precision medicine. Integration of multi-omics profiling, CTC-derived organoids, and AI-driven analytical models may further enhance their clinical utility in guiding personalized treatment strategies for ovarian and lung cancer patients.

This study clarifies the clinical relevance of cytoplasmic AR-V7 in circulating tumor cells from men with metastatic castration-resistant prostate cancer. While nuclear-localized AR-V7 predicts extremely poor response, PFS, and overall survival with AR pathway inhibitors, cytoplasmic AR-V7 expands the definition of AR-V7-positive status and identifies patients with equally poor PFS and intermediate response and overall survival outcomes. Assessing both nuclear and cytoplasmic AR-V7 fractions may thus improve risk stratification heterogeneity and could better guide poor-risk ARPI treatment decisions by avoiding ineffective ARPI treatment, helping personalize therapy, and improving outcomes in men with mCRPC.

P1, N=20, Active, not recruiting, Weill Medical College of Cornell University | Suspended --> Active, not recruiting | Phase classification: P1/2 --> P1 | N=48 --> 20 | Trial completion date: Dec 2027 --> Dec 2029 | Trial primary completion date: Dec 2026 --> Dec 2027

P=N/A, N=60, Recruiting, Heinrich-Heine University, Duesseldorf

P=N/A, N=187, Recruiting, Menarini Silicon Biosystems, INC | Not yet recruiting --> Recruiting | Trial completion date: Mar 2029 --> Oct 2028 | Trial primary completion date: Oct 2027 --> Oct 2028

P=N/A, N=100, Recruiting, IRCCS Azienda Ospedaliero-Universitaria di Bologna

PTEN loss appears to represent an early molecular alteration associated with adverse pathological features. Longer follow-up is needed to determine the predictive value of these biomarkers for recurrence and long-term outcomes.

When integrated with rVAR2-FETCH enrichment, our platform detected CTC in 83.67% (41/49) of non-small cell lung cancer patients, outperforming the complete CellSearch kit. Furthermore, machine learning models integrating CTC counts with hematological biomarkers achieved excellent diagnostic performance for lung cancer, with support vector machine demonstrating the best results (AUC = 0.977).

High CTC counts may potentially predict inferior outcomes after salvage lymph node dissection. As high counts are rare in early oligorecurrent PC, more sensitive CTC technologies and additional biomarkers are needed. The BioPoP study is registered on ClinicalTrials.gov as NCT04324983.