Circulating cfDNA and HPV as Prognostic Biomarkers for First-Line Recurrent Metastatic Cervical Cancer

This study plans to enroll patients with recurrent and metastatic cervical cancer who attain complete response after standard first-line systemic therapy. A total of 20 mL peripheral blood will be collected from each subject every 3 months over a planned one-year period (5 sampling time points in total). Plasma separated from blood samples will be subjected to quantitative detection and comparative analysis of circulating tumor DNA (ctDNA) and HPV-derived cell-free DNA (HPV cfDNA). Tumor tissue specimens (5-10 unstained paraffin sections) will also be collected from patients at the time of recurrent disease confirmation. It is estimated that 60 patients will be recruited and followed up dynamically for 3 years to observe clinical prognosis. This is a prospective, observational single-center cohort study. Peripheral blood samples will only be collected at scheduled time points to explore novel biomarkers associated with disease recurrence.

Inclusion criteria

• Histopathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
• Patients with first recurrent or metastatic cervical cancer (including primary stage IVB disease);
• Received standard first-line therapy (TP/TC regimen plus immunotherapy ± bevacizumab);
• Achieved complete response (CR) following standard first-line treatment;
• Archived pathological biopsy specimens of recurrent/metastatic lesions prior to treatment available in our hospital;
• Participated in clinical trials of pharmaceutical therapy for first-line recurrent/metastatic cervical cancer conducted at our institution;
• Voluntarily participates in this study and provides written informed consent;
• Agrees to serial peripheral blood collection at scheduled time points;
• Willing to complete scheduled follow-up visits;
• Aged ≥ 18 years old.

Exclusion criteria

• History of other malignant tumors within the past 2 years;
• Pregnant or breastfeeding women;
• Severe concomitant diseases, including: cardiovascular diseases (e.g., uncontrolled heart failure, unstable angina, etc.); pulmonary diseases (e.g., severe chronic obstructive pulmonary disease, interstitial pneumonia and other conditions impairing respiratory function); hepatic and renal dysfunction (e.g., decompensated liver cirrhosis, severe renal failure requiring dialysis, etc.);
• Refusal to sign informed consent;
• Refusal to undergo serial blood collection.