Dynamic Monitoring of Circulating Tumor DNA (ctDNA) and HPV DNA in Plasma for the Early Prediction of Recurrence After Cervical Cancer Surgery/Treatment

The Third Affiliated Hospital of Guangzhou Medical University1 site in 1 country150 target enrollmentJanuary 1, 2024

ConditionscfHPV DNA in Plasma of Cervical Cancer Patients

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: cfHPV DNA in Plasma of Cervical Cancer Patients
Sponsor: The Third Affiliated Hospital of Guangzhou Medical University
Enrollment: 150
Locations: 1
Primary Endpoint: sensitivity
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2024

End Date

January 30, 2027

Last Updated

last year

Study Type

Observational

Sex

Female

Investigators

Sponsor

The Third Affiliated Hospital of Guangzhou Medical University

Responsible Party

Principal Investigator

Sheng Xiujie

Professor

The Third Affiliated Hospital of Guangzhou Medical University

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.