Cervical Cancer, Metastatic Cervical Cancer, Recurrent Cervical Cancer
Conditions
Keywords
Cervical cancer, ctDNA, HPV cfDNA, Complete response, Prognosis
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTBiospecimen collection (peripheral blood and paraffin tumor tissue)
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.
Sponsors
Zhejiang Cancer Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histopathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; 2. Patients with first recurrent or metastatic cervical cancer (including primary stage IVB disease); 3. Received standard first-line therapy (TP/TC regimen plus immunotherapy ± bevacizumab); 4. Achieved complete response (CR) following standard first-line treatment; 5. Archived pathological biopsy specimens of recurrent/metastatic lesions prior to treatment available in our hospital; 6. Participated in clinical trials of pharmaceutical therapy for first-line recurrent/metastatic cervical cancer conducted at our institution; 7. Voluntarily participates in this study and provides written informed consent; 8. Agrees to serial peripheral blood collection at scheduled time points; 9. Willing to complete scheduled follow-up visits; 10. Aged ≥ 18 years old.
Exclusion criteria
1. History of other malignant tumors within the past 2 years; 2. Pregnant or breastfeeding women; 3. 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.); 4. Refusal to sign informed consent; 5. Refusal to undergo serial blood collection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival (DFS) | Up to 3 years after patient enrollment. | Time from enrollment to confirmation of disease recurrence or death from any cause, whichever occurs first, assessed over a 3-year follow-up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic changes of tumor ctDNA and HPV cfDNA to predict residual disease and tumor recurrence | Up to 3 years after enrollment | To evaluate the capacity of dynamic changes of tumor ctDNA and HPV cfDNA to predict residual disease and tumor recurrence in patients. |
| Overall Survival (OS) | Up to 3 years after enrollment | The proportion of patients surviving for 3 years from enrollment, defined as the time from study entry to death from any cause. |
Outcome results
None listed