Using blood and urine tests to detect cervical cancer
Official title: Plasma Circulating Tumor HPVDNA and Transrenal HPVDNA as Minimally Invasive Biomarkers for Cervical Cancer Detection and Surveillance Following Definitive Treatment
Run by UNC Lineberger Comprehensive Cancer Center · NCT04743674 · Data updated 2026-11-12
This study is testing if blood and urine tests can help find and track cervical cancer in patients more easily than current methods.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Locations | 2 sites (Chapel Hill, North Carolina and 1 other locations) |
| Status | Recruiting |
| Started | May 3, 2024 |
| Main results expected | January 15, 2027 |
| Study ends | January 15, 2027 |
| Registry record updated | May 12, 2026 |
| Trial ID | NCT04743674 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older with a new diagnosis of cervical cancer.
✕Probably not a fit
Women who are pregnant will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of circulating tumor HPV DNA (ctHPVDNA) and urine transrenal HPVDNA (TrHPVDNA) as non-invasive biomarkers for diagnosing and monitoring cervical cancer. Patients with newly diagnosed cervical cancer will have blood plasma and urine samples collected before and after treatment to assess the correlation between these biomarkers and the presence of the disease. The goal is to improve post-treatment surveillance and guide personalized treatment decisions by detecting early recurrences more effectively than current methods.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and less invasive monitoring of cervical cancer, improving patient outcomes.
How similar studies have gone: While the use of ctHPVDNA and TrHPVDNA as biomarkers is a novel approach, similar studies have shown promise in other cancer types, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older on day of signing informed consent * New diagnosis of cervical cancer * Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee Exclusion Criteria: * Women who are pregnant
Where it's running
-
Melissa Knutsen
Chapel Hill, North Carolina, United States Recruiting -
Kamuzu Central Hospital
Lilongwe, Malawi Not yet recruiting
Study contacts
- Principal investigator: Shivani Sud, MD — UNC
- Study coordinator: Melissa E Knutsen
- Email: melissa_knutsen@med.unc.edu
- Phone: 919-445-4869
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.