Circulating cfDNA and HPV as Prognostic Biomarkers for First-Line Recurrent Metastatic Cervical Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorZhejiang Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
Patients with recurrent and metastatic cervical cancer who achieved complete response after first-line systematic treatment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Biospecimen collection (peripheral blood and paraffin tumor tissue)
Diagnostic testLongitudinal 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Recurrent metastatic cervical cancer with complete response1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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 enrollment2
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 enrollmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: