Cervical Cancer, Human Papilloma Virus (HPV)
Conditions
Keywords
HPV, HPV Positive Cervical Cancer, Cervical Cancer, Recurrent Cervical Cancer
Brief summary
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.
Interventions
None listed
Sponsors
University of Florida
Florida Department of Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Agree to perform the required research-related blood tests and cervical mucous testing.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Circulating HPV DNA/mRNA Liquid Biopsy for Evaluating Treatment Response in Cervical Cancer | From enrollment to the end of the first surveillance visit, which occurs at 3-4 months post op or post-chemo, or at the patient's 3-4 month follow-up radiation therapy visit. | 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. |
Countries
United States
Contacts
CONTACTKari S Bastow, BS
CONTACTAmy Carrao-Tackett, MPH
Outcome results
None listed