Using Plasma Human Papillomavirus (HPV)-Related Deoxyribonucleic Acid (DNA) and Ribonucleic Acid … (NCT07214584) | Clinical Trial Compass
RecruitingNot Applicable
Using Plasma Human Papillomavirus (HPV)-Related Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA) to Follow Response of Cervical Cancer to Surgery, Radiation, and Chemotherapy
United States55 participantsStarted 2025-12-15
Plain-language 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.
Who can participate
Age range
18 Years – 89 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of Circulating HPV DNA/mRNA Liquid Biopsy for Evaluating Treatment Response in Cervical Cancer
Timeframe: 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.