Primary Objective of this study: To investigate the correlation between longitudinal quantitative dynamics of circulating tumor DNA (ctDNA) and HPV-derived cell-free DNA (HPV cfDNA) in peripheral blood and clinical prognosis among patients with recurrent and metastatic cervical cancer who achieved complete response following standard first-line systemic therapy.
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.
Study Type
OBSERVATIONAL
Enrollment
60
Longitudinal collection of peripheral blood plasma at scheduled time points and collection of archived paraffin-embedded recurrent tumor tissue sections for ctDNA and HPV cfDNA quantitative detection, HPV genotyping and gene variation analysis.
Disease-free survival (DFS)
Time from enrollment to confirmation of disease recurrence or death from any cause, whichever occurs first, assessed over a 3-year follow-up period.
Time frame: Up to 3 years after patient enrollment.
Dynamic changes of tumor ctDNA and HPV cfDNA to predict residual disease and tumor recurrence
To evaluate the capacity of dynamic changes of tumor ctDNA and HPV cfDNA to predict residual disease and tumor recurrence in patients.
Time frame: Up to 3 years after enrollment
Overall Survival (OS)
The proportion of patients surviving for 3 years from enrollment, defined as the time from study entry to death from any cause.
Time frame: Up to 3 years after enrollment
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