Circulating tumor DNA in clinical trials for solid tumors: Challenges and current applications

Area of Science:

• Oncology
• Molecular Diagnostics
• Biomarker Discovery

Background:

• Liquid biopsy (LB) detects tumor-derived biomarkers like circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs).
• ctDNA analysis via LB is established for monitoring treatment response and identifying resistance mechanisms in advanced cancers.
• Applications span cancer diagnosis, post-curative surveillance (e.g., minimal residual disease), and early-phase clinical trials.

Purpose of the Study:

• To review the primary applications and challenges of ctDNA genotyping within clinical trials.
• To focus on ongoing studies and next-generation academic and industry-sponsored programs.
• To discuss the impact of ctDNA technology on early cancer detection and prevention in high-risk groups.

Main Methods:

• Review of current literature and ongoing clinical studies involving ctDNA analysis.
• Analysis of ctDNA technology's role in clinical trial design, patient selection, and treatment monitoring.
• Examination of emerging academic and industry initiatives for early cancer detection using ctDNA.

Main Results:

• ctDNA analysis is increasingly integrated into clinical trials, influencing patient enrollment and treatment strategies.
• The focus is shifting from technological capability to result interpretation for clinical decision-making.
• Significant academic and industry programs are emerging for early cancer detection and prevention.

Conclusions:

• ctDNA genotyping is a rapidly evolving field with substantial implications for cancer diagnosis, prognosis, and treatment.
• Interpreting ctDNA results and their clinical impact remains a key challenge.
• Future directions include large-scale programs for early cancer detection and prevention in high-risk populations.