Circulating Human Papilloma Virus (HPV) DNA for the Screening and Surveillance of Gynecologic Cancers
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Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Jeannine Villella, MD; Elena Pereira, MD
Data sourced from clinicaltrials.gov
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