Dynamic Monitoring of ctDNA and HPV DNA in Plasma for the Early Prediction of Recurrence After Cervical Cancer Surgery

Recruiting

• Conditions: cfHPV DNA in Plasma of Cervical Cancer Patients

• Registration Number: NCT06420427
• Lead Sponsor: The Third Affiliated Hospital of Guangzhou Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Last Update Submitted: 2024-05-14
• Study First Posted: 2024-05-20
• Last Update Posted: 2024-05-20
• Primary Completion: 2025-12-31
• Study Completion: 2027-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sensitivity	2 year	true positive rate

Trial Locations

Locations (1)

The Third Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China