Research Article: Plasma HPV ctDNA as a dynamic biomarker for treatment response and prognosis in locally advanced cervical cancer: protocol for a prospective cohort study
Abstract:
Locally advanced cervical cancer (LACC) remains a major global health burden, and current imaging-based assessment after standard concurrent chemoradiotherapy (CCRT) is limited by delayed detection of treatment failure and poor sensitivity for microscopic residual disease. Circulating human papillomavirus DNA (HPV ctDNA) represents a tumor-specific biomarker with potential for real-time treatment monitoring. This prospective cohort study aims to evaluate whether dynamic monitoring of plasma HPV ctDNA can predict treatment response and prognosis in patients with LACC receiving CCRT.
This single-center, observational cohort study will enroll 57 patients with histologically confirmed LACC (FIGO 2018 stage IB2–IVA) and baseline high-risk HPV infection. All patients will receive standard CCRT including external beam radiotherapy (45–50.4 Gy), concurrent weekly cisplatin (40 mg/m²), and intracavitary brachytherapy. Peripheral blood samples (10 mL) will be collected at five predefined time points: baseline (T0), mid-treatment (T1), end of CCRT (T2), 3 months post-CCRT (T3), and every 6 months thereafter for 24 months. Plasma HPV ctDNA will be quantified using droplet digital PCR targeting HPV16/18 E6/E7 genes. The primary endpoint is progression-free survival (PFS), comparing patients with detectable versus undetectable ctDNA at 3 months post-CCRT.
This study will provide prospective evidence for HPV ctDNA as a minimally invasive biomarker for treatment monitoring and prognostic stratification in LACC, potentially informing future risk-adapted therapeutic strategies.
Introduction:
Locally advanced cervical cancer (LACC) remains a major global health burden, and current imaging-based assessment after standard concurrent chemoradiotherapy (CCRT) is limited by delayed detection of treatment failure and poor sensitivity for microscopic residual disease. Circulating human papillomavirus DNA (HPV ctDNA) represents a tumor-specific biomarker with potential for real-time treatment monitoring. This prospective cohort study aims to evaluate whether dynamic monitoring of plasma HPV ctDNA can predict…
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