Study on the efficacy and prognostic value of minimal residual disease in locally advanced cervical cancer based on plasma HPV-ctDNA protocol

Abstract

Background The recurrence and/or distant metastasis rate of locally advanced cervical cancer is still high after treatment. Current methods commonly used in clinical follow-up surveillance of cervical cancer still have some limitations. Important advances have been made in liquid biopsy-based circulating tumor DNA (ctDNA) for the assessment of microscopic residual disease (MRD) (ctNDA/MRD), and recent studies have found that human papillomavirus (HPV)-ctDNA-based assessment of MRD status is perhaps even more advantageous (HPV/MRD). However, it remains uncertain whether plasma HPV-ctDNA-based assessment of locally advanced cervical cancer efficacy and monitoring of prognosis is accurate and effective. Methods This study was a prospective, observational, single-center study to explore the predictive significance of monitoring HPV/MRD and ctDNA/MRD status on the efficacy and recurrence risk of cervical cancer after concurrent chemoradiotherapy. Patients with locally advanced cervical cancer who were treated in Guizhou Provincial People's Hospital were collected for tissue and blood samples for HPV testing and liquid biopsy HPV-ctDNA. The primary study endpoint is to detect the changes in MRD expression level before and after simultaneous radiotherapy for cervical cancer and to evaluate the efficacy and recurrence risk after simultaneous radiotherapy for cervical cancer. The secondary study endpoint is to analyze the role of MRD detection and imaging in predicting tumor recurrence and metastasis. The target sample size was 30 patients. Discussion This is a prospective study to explore the role of MRD based on HPV-ctDNA assessment in the efficacy and prognosis monitoring of concurrent chemoradiotherapy for locally advanced cervical cancer. It aims to provide important theoretical and practical significance for the evaluation of the efficacy and prognosis of locally advanced cervical cancer after concurrent chemoradiotherapy and to provide new methods for intervention in the recurrence of potential cervical cancer after treatment. Trial registration This trial is registered at the ClinicalTrials.gov (NCT05950087) on 18th July 2023, https://www.clinicaltrials.gov/ct2/show/NCT05950087.