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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
Who can join
Ages 18 and older · Women
Full eligibility 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.
About the study
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.
What is being tested
- NavDx(R) (diagnostic test)
Sponsor: Northwell Health · Participants: 100 · Started: Aug 10, 2022
Contact the study team
- Elena Pereira, MD · Phone: 2124343770
- Jeannine Villella, MD · Phone: 2124343770
Official record on ClinicalTrials.gov — NCT05606133
Locations in the U.S.
| New York | Lenox Hill Hospital, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.