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Study identifier: NCT05606133 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Cervical Dysplasia · Cervical Cancer  ·  Sponsor: Northwell Health

PhaseNA
Planned participants100
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this 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.

This description comes directly from the study's public registry record.

Talk to the study team

Elena Pereira, MD  ·  2124343770  ·  epereira2@northwell.edu

Jeannine Villella, MD  ·  2124343770  ·  jvillella@northwell.edu

Always discuss trial participation with your own doctor first.

Locations (1)

Lenox Hill HospitalNew York, New York, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05606133