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

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.

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Key information

Conditions

cfHPV DNA in Plasma of Cervical Cancer Patients Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510150, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Assess the risk of recurrence and the efficacy of medication

Diagnostic Test

Evaluation of recurrence risk and medication efficacy through liquid biopsy

Primary outcomes

sensitivity

Time frame: 2 year

true positive rate

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

The Third Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2027
First posted: May 20, 2024
Registry last updated: May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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