Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Evaluation of the Clinical Utility of Circulating Tumor DNA in the Management of Patients with Non-Metastatic Head and Neck Cancer: Protocol for a Prospective Bicentric Study (CIRVAD)
ABSTRACT
Background:
HPV-negative head and neck cancers, often linked to tobacco and alcohol, have poor prognosis and high recurrence rates. Circulating tumor DNA (ctDNA) is a promising biomarker for detecting minimal residual disease and monitoring treatment response. Recent studies show ctDNA can detect recurrence earlier than clinical or radiological methods. Prospective trials are needed to validate its clinical utility.
Objective:
The primary objective is to assess postoperative circulating tumor DNA as a predictor of 28-month progression-free survival. Secondary objectives include evaluating ctDNA levels before and after treatment as predictors of recurrence, studying ctDNA dynamics during follow-up in relation to survival, and exploring their association with tumor characteristics and surgical outcomes.
Methods:
This prospective, bicentric study evaluates circulating tumor DNA in patients undergoing surgery for head and neck squamous cell carcinoma. Plasma ctDNA concentrations will be measured quantitatively in ng/mL before and one to two weeks after surgery, with or without adjuvant radiotherapy or chemotherapy. Progression-free survival is defined as the time from surgery to disease progression or death, and recurrence-free survival as the time to clinically confirmed recurrence. Overall and disease-specific survival will also be assessed. Changes in ctDNA levels over follow-up and clinical characteristics will be compared between patients with and without progression at 28 months. Absolute and relative variations in ctDNA pre- and postoperatively will be described, and surgical quality evaluated according to resection margins (R0, R1, R2).
Results:
No results are available yet as the study is in the planning phase
Conclusions:
This study aims to provide key data on the potential of circulating tumor DNA to detect early recurrence in HPV-negative cancers and could inform personalized patient monitoring and management. Clinical Trial: Trial registration: Not applicable International registered report identifier (IRRID): Not applicable
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.