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Implementation of Circulating HPV DNA for the Screening and Surveillance of HPV-related Gynecologic Cancers
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Lenox Hill Hospital
New York, New York, United States
Start Date
August 10, 2022
Primary Completion Date
August 10, 2026
Completion Date
August 10, 2026
Last Updated
September 23, 2025
100
ESTIMATED participants
NavDx(R)
DIAGNOSTIC_TEST
Lead Sponsor
Northwell Health
Collaborators
NCT06349642
NCT05639972
Data Source & Attribution
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