Study of a Blood Test Detecting HPV DNA for Screening and Monitoring HPV-Related Cervical Dysplasia and Cancer in Women

What this Trial Is About

Human papilloma virus HPV-related gynecologic cancers impact over 20,000 women annually in the United States and more than half a million women worldwide. High-grade cervical dysplasia, a pre-cancerous condition, affects about 200,000 women each year. Currently, there is no serum biomarker available for these tumors, and diagnosis often requires invasive testing. This research aims to evaluate a new blood test that detects circulating tumor-specific HPV DNA to help distinguish pre-invasive from invasive cervical cancers. The study will use a blood test called NavDx4, developed by the molecular diagnostics company Naveris. This test uses digital droplet polymerase chain reaction PCR to measure fragments of tumor-specific DNA shed by HPV-related cancer cells in the blood. The study involves measuring circulating HPV DNA before treatment, during treatment up to 8 weeks, and after treatment at 8 to 12 weeks. Participants will have blood drawn at these time points to measure plasma cell-free HPV DNA. The researchers will monitor how well the levels of circulating HPV DNA correlate with the presence and progression of cervical dysplasia or invasive cervical cancer. The study is sponsored by Northwell Health and aims to assess if this blood test could provide a less invasive method for cancer screening and surveillance.

Circulating Human Papilloma Virus (HPV) DNA for the Screening and Surveillance of Gynecologic Cancers