NavDx(R) Blood Test for Gynecologic Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new blood test, NavDx(R), designed to detect DNA from HPV-related cancer cells in the blood. The goal is to simplify the diagnosis and monitoring of cervical cancers without invasive procedures. The test will identify whether someone has a pre-cancerous condition or invasive cervical cancer. Women diagnosed with high-grade cervical dysplasia or invasive cervical cancer, both linked to HPV, are ideal candidates for this study. As an unphased trial, participants can contribute to groundbreaking research that could simplify cancer diagnosis and monitoring.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this blood test is safe for detecting gynecologic cancers?
Research shows that the NavDx blood test is safe for people. This test detects and measures specific DNA from HPV-related cancers in the blood. It is non-invasive, requiring only a simple blood draw, which is much easier and safer than more invasive procedures like biopsies.
The test has been clinically validated, meaning it has been tested in real-world settings and proven effective in detecting HPV-driven cancers. While sources do not specifically mention any side effects, blood tests generally carry very low risk. The most common issues might be minor, such as slight bruising or discomfort at the needle site.
Overall, available information suggests that the NavDx blood test is well-tolerated and safe for use.12345Why are researchers excited about this trial?
Researchers are excited about the NavDx(R) blood test for gynecologic cancers because it offers a non-invasive way to detect circulating HPV DNA, which is linked to these cancers. Unlike traditional methods that often rely on tissue biopsies, which can be invasive and uncomfortable, this blood test allows for simpler and more frequent monitoring. This approach could lead to earlier detection and treatment, potentially improving outcomes for patients.
What evidence suggests that the NavDx(R) blood test is effective for detecting gynecologic cancers?
Research has shown that the NavDx blood test, provided to participants in this trial, offers a promising method for detecting and monitoring HPV-related gynecologic cancers. This test accurately identifies fourteen types of high-risk HPV linked to these cancers. Studies have found that HPV DNA in the blood strongly indicates early cancer detection and aids in tracking cancer progression and treatment response. The NavDx test is the first blood test proven in clinical settings to detect and monitor HPV-driven cancers, offering a potentially effective and less invasive option for patients.678910
Are You a Good Fit for This Trial?
This trial is for individuals over 18 years old who have been diagnosed with high-grade cervical dysplasia or invasive cervical cancer related to HPV. It's not open to those who don't meet these specific conditions.Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Treatment
Quantification of plasma cell-free HPV DNA to distinguish pre-invasive from invasive cervical cancers
On-Treatment
Monitoring of circulating HPV DNA during treatment
Post-Treatment
Assessment of circulating HPV DNA after treatment completion
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NavDx(R)
Trial Overview
The study is testing NavDx(R), a blood test designed to detect fragments of tumor-specific DNA from HPV-associated cancers using advanced PCR techniques, aiming to distinguish between pre-invasive and invasive cervical cancers.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwell Health
Lead Sponsor
Naveris
Collaborator
Citations
Analytical Validation of NavDx+Gyn, a cfDNA-Based ...
Conclusions: These results demonstrate that NavDx+Gyn accurately and reproducibly detects fourteen types of high-risk HPV, which aids in the ...
Prognostic value of HPV DNA in cervical cancer: liquid biopsy
Recent studies have identified circulating cell-free HPV (ccfHPV) DNA as a promising biomarker for the early detection and prognosis of cervical ...
Monitoring circulating cell-free HPV DNA in metastatic or ...
HPV cfDNA is a highly effective tumor marker for monitoring disease progression and treatment response in HPV-positive cervical cancer, ...
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researchgate.net
researchgate.net/publication/390189353_Analytical_Validation_of_NavDxGyn_a_cfDNA-Based_Fragmentomic_Profiling_Assay_for_HPV-Driven_Gynecologic_Cancers(PDF) Analytical Validation of NavDx+Gyn, a cfDNA-Based ...
Conclusions: These results demonstrate that NavDx+Gyn accurately and reproducibly detects fourteen types of high-risk HPV, which aids in the ...
Use in HPV+ Cancers
The NavDx test is the first and only clinically validated circulating TTMV-HPV DNA blood test that can aid in the detection and monitoring of HPV-driven cancer.
Analytical Validation of NavDx+Gyn, a cfDNA-Based ...
The NavDx+Gyn blood test detects and quantifies fourteen HPV types in various sample types to provide a reliable means of detecting and monitoring HPV-driven ...
NavDx: Home
Optimize the management of HPV-positive cancer with NavDx—an innovative TTMV-HPV DNA blood test that helps physicians personalize every phase of treatment.
WHAT IS NavDx
NavDx is the first and only clinically validated circulating tumor-tissue–modified HPV (TTMV®) DNA blood test that aids in the detection of HPV-driven cancer.
News - NavDx
'....This new data further reinforces the clinical value of TTMV-HPV DNA testing in HPV-positive cancers, as supported by more than 30 peer reviewed ...
Analytical Validation of NavDx, a cfDNA-Based ...
The NavDx blood test analyzes tumor tissue modified viral (TTMV)-HPV DNA to provide a reliable means of detecting and monitoring HPV-driven cancers.
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