The goal of this study is to test two commercially available technologies for their ability to detect treatment response in patients with cervical cancer following surgery, radiation, and chemotherapy: one based on polymerase chain reaction (PCR; NavDx) and the other on branched DNA (Quantivirus HPV \[DNA\]). A 9-month feasibility study will be performed to examine the side-by-side utility of both NavDx and Quantivirus HPV DNA assays in predicting cervical cancer treatment response.
These tests could prove to be highly sensitive methods for evaluating minimal residual disease and for quantitation of response to surgery, radiation, and chemotherapy in patients with cervical cancer.
Primary Goal:
Feasibility for NavDx HPV DNA assay (Naveris, Inc) to be used for personalized prediction of tumor response before and after treatment.
Secondary Goals:
1. Comparability of the Quantivirus HPV DNA/mRNA assay (DiaCarta, Inc) with the NavDx HPV DNA assay and, 2. Feasibility of the Quantivirus technology for measuring treatment response within the first day to 2 weeks of radiation, surgery, or a new chemotherapy.
18 years and older
HPV-associated squamous cell, adenocarcinoma, or adenosquamous cancers of the uterine cervix with evaluable disease
Diagnosed with American Joint Committee on Cancer (AJCC) stage I or higher, or metastatic disease.
Presence of evaluable disease on pre-treatment standard of care imaging with plans to obtain serial post-treatment standard of care imaging
Unable to consent or refusal to sign a consent form
Not meet any inclusion criteria
Unable to comply with follow up scheduling.
Diagnosed with a synchronous malignancy requiring cancer-directed therapy
Female patients with HPV associated cancers of the uterine cervix with active, evaluable/measurable disease.
Cohort
Prospective
Not listed
Feasibility of Circulating HPV DNA/mRNA Liquid Biopsy for Evaluating Treatment Response in Cervical Cancer
This is a feasibility study to determine the sensitivity of circulating HPV DNA/mRNA, measured by either or both NavDx or Quantivirus as a liquid biopsy, to evaluate treatment response in cervical cancer.
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University of Florida
Lead sponsor
Florida Department of Health
Collaborator
