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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05606133

Enrollment

100

Registered

2022-11-04

Start date

2022-08-10

Completion date

2026-08-10

Last updated

2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Cervical Dysplasia

Brief 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.

Interventions

DIAGNOSTIC_TESTNavDx(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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Pre-Treatment Circulating HPV DNA	Week 0	The presence or absence of ct-HPV DNA
On-Treatment Circulating HPV DNA	Up to 8 weeks	The presence or absence of ct-HPV DNA
Post-Treatment Circulating HPV DNA	8-12 weeks	The presence or absence of ct-HPV DNA

Countries

United States

Contacts

Primary ContactElena Pereira, MD

epereira2@northwell.edu2124343770

Backup ContactJeannine Villella, MD

jvillella@northwell.edu2124343770

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026