Using blood and urine tests to detect cervical cancer
Plasma Circulating Tumor HPVDNA and Transrenal HPVDNA as Minimally Invasive Biomarkers for Cervical Cancer Detection and Surveillance Following Definitive Treatment
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 |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Locations | 2 sites (Chapel Hill, North Carolina and 1 other locations) |
| Trial ID | NCT04743674 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a new diagnosis of cervical cancer.
Not a fit: Women who are pregnant will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Chapel Hill, North Carolina and 1 other locations
- 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
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.