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

Not Applicable

Recruiting

• Conditions: Cervical Cancer; Cervical Dysplasia
• Interventions: Diagnostic Test: NavDx(R)

• Registration Number: NCT05606133
• Lead Sponsor: Northwell Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-10
• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-10-31
• Study First Posted: 2022-11-04
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-02
• Primary Completion: 2024-08-10
• Study Completion: 2024-08-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Circulating HPV DNA	NavDx(R)	-

Primary Outcome Measures

Name	Time	Method
Pre-Treatment Circulating HPV DNA	Week 0	The presence or absence of ct-HPV DNA
Post-Treatment Circulating HPV DNA	8-12 weeks	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

Trial Locations

Locations (1)

Lenox Hill Hospital; 🇺🇸 New York, New York, United States