Blood test for detecting HPV-related gynecologic cancers
Official title: Implementation of Circulating HPV DNA for the Screening and Surveillance of HPV-related Gynecologic Cancers
Run by Northwell Health · NCT05606133 · Data updated 2026-11-12
This study is testing a blood test that looks for HPV-related cancer DNA in women with serious cervical issues to see if it can help detect and monitor these cancers without needing invasive procedures.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | August 10, 2022 |
| Main results expected | August 10, 2026 |
| Study ends | August 10, 2026 |
| Registry record updated | September 23, 2025 |
| Trial ID | NCT05606133 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women over the age of 18 with biopsy-proven HPV-related high-grade cervical dysplasia or invasive cervical cancer.
✕Probably not a fit
Patients who do not have HPV-related high-grade cervical dysplasia or cervical cancer 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 a blood test designed to detect circulating tumor-specific HPV DNA in women diagnosed with high-grade cervical dysplasia or cervical cancer. By utilizing digital droplet polymerase chain reactions (PCR), the test seeks to quantify fragments of tumor-specific DNA shed by HPV-associated cancer cells. The goal is to provide a non-invasive method for screening and monitoring these conditions, potentially reducing the need for invasive procedures. The collaboration with Naveris, a molecular diagnostics company, enhances the study's approach to improving gynecologic cancer care.
Why it matters
Potential benefit: If successful, this blood test could significantly improve the early detection and monitoring of HPV-related gynecologic cancers, leading to better patient outcomes.
How similar studies have gone: While there is ongoing research in non-invasive cancer detection methods, this specific approach using circulating HPV DNA is novel and has not been widely tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: All patients above age 18, with biopsy proven HPV-related high-grade cervical dysplasia or invasive cervical cancer will be included. Exclusion Criteria: Persons who do not meet the above inclusion criteria.
Where it's running
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Lenox Hill Hospital
New York, New York, United States Recruiting
Study contacts
- Study coordinator: Elena Pereira, MD
- Email: epereira2@northwell.edu
- Phone: 2124343770
Similar studies
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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.