Using Plasma HPV related DNA and RNA to Follow Response of Cervical Cancer to Surgery, Radiation, and Chemotherapy
-
StatusAccepting Candidates
-
Age18 Years - 89 Years
-
SexesFemale
-
Healthy Volunteers
Description
The vast majority of cervical cancer is caused by the human papillomavirus (HPV). Oncogenesis occurs through incorporation of viral DNA into nuclear DNA. We postulate that tumor cell death leads to circulating HPV DNA. We expect its level at a steady state to represent the patient’s tumor burden. Similarly, acute spikes in HPV DNA in the first days after radiation indicate tumor response to effective treatment. If this simple approach proves true, timely information on tumor response could revolutionize the therapy of cervical cancer. We will test two methods, the standard polymerase chain reaction (PCR)-based assay and the commercially available branched DNA (Quantivirus HPV [DNA]) for their ability to detect tumor response following surgery, radiation, and chemotherapy. PCR is a laboratory technique used to rapidly amplify and detect specific segments of DNA, allowing precise identification and quantification of genetic material. The branched DNA Quantivirus assay was developed by 蹤獲扦 scientists and has the advantage of international utility, greater deploy-ability, lower cost, and quantitative accuracy. A potential advantage of the Quantivirus assay is allowance for more frequent testing and, therefore, more timely outcome information to aid physician decision making and evaluate treatment progress. As a weakness, it has a higher limit of detection. We will perform a 9 month feasibility study to examine the side by side utility of both the PCR and Quantivirus HPV DNA assays in predicting treatment response.
Neither test will be used as a form of therapy (and will not guide or alter standard of care therapy), nor does the study provide any additional interventional therapy to participants - the study is strictly observational.
Details
| Protocol number | 202501136 |
Eligibility
inclusion:
1:18 yrs and older patients who have been diagnosed HPV associated squamous cancer of uterine cervix with active, measurable /evaluable disease.
2: Agreeable to multiple blood samples and a cervical swab.
Exclusion:
Diagnosed with other malignancies requiring cancer directed therapy.
Lead researcher
-
Karina E Hew, MDGynecologic Oncologist
Participate in a study
Here are some general steps to consider when participating in a research study:
-
Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
-
Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
-
Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
-
Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.