Dynamic Monitoring of ctDNA and HPV DNA in Plasma for the Early Prediction of Recurrence After Cervical Cancer Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Assess the risk of recurrence and the efficacy of medication.
- Who it may be relevant to
- Registry conditions: cfHPV DNA in Plasma of Cervical Cancer Patients. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dynamic Monitoring of Circulating Tumor DNA (ctDNA) and HPV DNA in Plasma for the Early Prediction of Recurrence After Cervical Cancer Surgery/Treatment
Overview
Assess the sensitivity, specificity, positive predictive value, and negative predictive value of dynamic monitoring of circulating tumor DNA (ctDNA) combined with circulating HPV DNA (cfHPV DNA) for early prediction of recurrence in cervical cancer post-surgery or post-treatment, and compare its advantages and disadvantages with existing diagnostic methods.
Interventions
- Diagnostic test Assess the risk of recurrence and the efficacy of medication
Evaluation of recurrence risk and medication efficacy through liquid biopsy
Primary outcome measures
- sensitivity [Time frame: 2 year]
Eligibility criteria
Inclusion criteria
- Patients with newly diagnosed HPV-positive cervical malignancy at stages I-IV who have not undergone surgery, radiation therapy, or chemotherapy.
- Patients must be older than 18 years of age.
- Cervical cancer patients who are eligible for surgery and/or chemoradiotherapy.
- Estimated life expectancy of more than three months.
- Understands the study protocol and voluntarily participates in the research by signing the informed consent form.
- Able to provide specimens and corresponding clinical information at each time point.
Exclusion criteria
- Patients who are participating in other clinical trials.
- Pregnant or breastfeeding women.
- Patients with severe mental illness.
- Patients who voluntarily withdraw.
- Patients unable to complete the study protocol.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The Third Affiliated Hospital of Guangzhou Medical University — Guangzhou
Identifiers
NCT: NCT06420427 · CCA2024005