NCT05606133

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

Implementation of Circulating HPV DNA for the Screening and Surveillance of HPV-related Gynecologic Cancers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Human papilloma virus-related gynecologic malignancies affect over 20,000 women in the United States, and over half a million women globally each year. In addition, approximately 200,000 women are diagnosed with high-grade cervical dysplasia, a pre-cancerous tumor. There is no currently available serum biomarker for these tumors, and surveillance and diagnosis in these patients often requires invasive testing and procedures. The ability to diagnose and monitor for these cancers with a simple blood draw would have a significant impact both here in the US and abroad. In order to detect circulating tumor-specific HPV DNA, the investigators will collaborate with the molecular diagnostics company, Naveris. Naveris has designed a blood test that utilizes digital droplet polymerase chain reactions (PCR) in order to quantify fragments of tumor-specific DNA that the investigators believe is shed by HPV-associated cancer cells in the blood. In this pilot study, the investigators will first test whether the quantification of plasma cell-free HPV DNA can distinguish pre-invasive from invasive cervical cancers.

Conditions

• Cervical Dysplasia
• Cervical Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	NavDx(R)	NavDx® is a blood test that utilizes digital droplet PCR in order to quantify fragments of tumor-specific DNA shed by HPV-associated cancer cells in the blood. The technology has the ability to distinguish tumor-tissue modified virus particles present in the plasma cell-free DNA from non-cancer associated sources of HPV DNA.

Timeline

• Start date: 2022-08-10
• Primary completion: 2026-08-10
• Completion: 2026-08-10
• First posted: 2022-11-04
• Last updated: 2025-09-23

Locations

1 site across 1 country: United States