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NCT Number: NCT05606133

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

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Key information

Conditions

Cervical Dysplasia Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Precancerous Conditions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NavDx(R)

Diagnostic Test

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.

Primary outcomes

  1. Pre-Treatment Circulating HPV DNA

    Time frame: Week 0

    The presence or absence of ct-HPV DNA

  2. On-Treatment Circulating HPV DNA

    Time frame: Up to 8 weeks

    The presence or absence of ct-HPV DNA

  3. Post-Treatment Circulating HPV DNA

    Time frame: 8-12 weeks

    The presence or absence of ct-HPV DNA

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Pereira, MD

CONTACT

[email protected]

2124343770

Jeannine Villella, MD

CONTACT

[email protected]

2124343770

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Naveris

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 4, 2022
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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