Monitoring blood markers to predict cervical cancer recurrence after surgery
Dynamic Monitoring of Circulating Tumor DNA (ctDNA) and HPV DNA in Plasma for the Early Prediction of Recurrence After Cervical Cancer Surgery/Treatment
This study is testing if checking certain blood markers can help predict if cervical cancer will come back after surgery in patients with HPV-positive cervical cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The Third Affiliated Hospital of Guangzhou Medical University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06420427 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of monitoring circulating tumor DNA (ctDNA) and circulating HPV DNA (cfHPV DNA) in the blood of cervical cancer patients to predict the likelihood of cancer recurrence following surgery. By assessing the sensitivity, specificity, and predictive values of these biomarkers, the study seeks to determine their advantages over existing diagnostic methods. Patients with newly diagnosed HPV-positive cervical cancer who are eligible for surgery will be monitored for changes in these markers to assess their risk of recurrence.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with newly diagnosed HPV-positive cervical cancer at stages I-IV who are eligible for surgery.
Not a fit: Patients who are pregnant, breastfeeding, or have severe mental illness may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of cervical cancer recurrence, allowing for timely intervention.
How similar studies have performed: While similar approaches have been explored, this specific combination of ctDNA and cfHPV DNA monitoring for cervical cancer recurrence prediction is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- The Third Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Xiujie Sheng, Prof
- Email: 2008691150@gzhmu.edu.cn
- Phone: 86-20-81292726
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.