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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• All patients above age 18, with biopsy proven HPV-related high-grade cervical dysplasia or invasive cervical cancer will be included.

Locations
United States
New York
Lenox Hill Hospital
RECRUITING
New York
Contact Information
Primary
Elena Pereira, MD
epereira2@northwell.edu
2124343770
Backup
Jeannine Villella, MD
jvillella@northwell.edu
2124343770
Time Frame
Start Date: 2022-08-10
Estimated Completion Date: 2026-08-10
Participants
Target number of participants: 100
Treatments
Experimental: Circulating HPV DNA
Sponsors
Collaborators: Naveris
Leads: Northwell Health

This content was sourced from clinicaltrials.gov