RecruitingNCT06420427

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

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


Sponsor

The Third Affiliated Hospital of Guangzhou Medical University

Enrollment

150 participants

Start Date

Jan 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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.

Interventions

DIAGNOSTIC_TESTAssess the risk of recurrence and the efficacy of medication

Evaluation of recurrence risk and medication efficacy through liquid biopsy


Locations(1)

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

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NCT06420427