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

Sponsor
Northwell Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT05606133
Collaborator
Naveris (Other)
100
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: NavDx(R)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Implementation of Circulating HPV DNA for the Screening and Surveillance of HPV-related Gynecologic Cancers
Actual Study Start Date :
Aug 10, 2022
Anticipated Primary Completion Date :
Aug 10, 2024
Anticipated Study Completion Date :
Aug 10, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Circulating HPV DNA

Diagnostic Test: NavDx(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.

Outcome Measures

Primary Outcome Measures

  1. Pre-Treatment Circulating HPV DNA [Week 0]

    The presence or absence of ct-HPV DNA

  2. On-Treatment Circulating HPV DNA [Up to 8 weeks]

    The presence or absence of ct-HPV DNA

  3. Post-Treatment Circulating HPV DNA [8-12 weeks]

    The presence or absence of ct-HPV DNA

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lenox Hill Hospital New York New York United States 10075

Sponsors and Collaborators

  • Northwell Health
  • Naveris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Elena Pereira, Assistant Professor, Northwell Health
ClinicalTrials.gov Identifier:
NCT05606133
Other Study ID Numbers:
  • 22-0247
First Posted:
Nov 4, 2022
Last Update Posted:
Nov 4, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia

Study Results

No Results Posted as of Nov 4, 2022