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Trial Title:
Circulating Human Papilloma Virus (HPV) DNA for the Screening and Surveillance of Gynecologic Cancers
NCT ID:
NCT05606133
Condition:
Cervical Dysplasia
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Dysplasia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
NavDx(R)
Description:
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.
Arm group label:
Circulating HPV DNA
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Lenox Hill Hospital
Address:
City:
New York
Zip:
10075
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elena Pereira, MD
Phone:
212-434-3770
Email:
epereira2@northwell.edu
Contact backup:
Last name:
Jeannine Villella, MD
Phone:
2124343770
Email:
jvillella@northwell.edu
Start date:
August 10, 2022
Completion date:
August 10, 2024
Lead sponsor:
Agency:
Northwell Health
Agency class:
Other
Collaborator:
Agency:
Naveris
Agency class:
Other
Source:
Northwell Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05606133
