Blood test for detecting HPV-related gynecologic cancers
Implementation of Circulating HPV DNA for the Screening and Surveillance of HPV-related Gynecologic Cancers
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05606133 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who do not have HPV-related high-grade cervical dysplasia or cervical cancer will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
New York, New York
- Lenox Hill Hospital — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Elena Pereira, MD
- Email: epereira2@northwell.edu
- Phone: 2124343770
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.