NavDx for Oropharyngeal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a blood test called NavDx® can help detect HPV-related oropharyngeal cancer early by identifying HPV DNA in the bloodstream. HPV, a common virus, can sometimes lead to cancer in the throat area. The trial seeks participants who have had four or more lifetime sexual partners and at least one lifetime oral sexual partner, and who have not been diagnosed with HPV-related head and neck cancer before. Those who meet these criteria might find this trial suitable. As a Phase 2 trial, the research focuses on measuring the blood test's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in early detection.
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.
What prior data suggests that this blood test is safe for detecting HPV-related Oropharyngeal Cancer?
Research has shown that the NavDx blood test detects small pieces of DNA from the Human Papillomavirus (HPV) in the bloodstream. This test reliably detects HPV-related cancers, such as those in the head and neck. While specific safety data for humans is not available, the test has been used effectively to monitor these cancers, suggesting its safety. The NavDx test is already in use in medical settings, indicating a good safety record. However, joining a clinical trial is a personal choice, and discussing any concerns with a healthcare provider is advisable.12345
Why are researchers excited about this trial?
Researchers are excited about using NavDx for detecting HPV-related oropharyngeal cancer because it utilizes HPV DNA testing, a non-invasive method that can potentially identify cancer earlier than traditional methods, like biopsies or imaging. Unlike standard treatments that focus on treating cancer after it is diagnosed, NavDx aims to improve early detection, which could lead to timely and more effective interventions. This approach could revolutionize how we monitor and manage HPV-related oropharyngeal cancer, offering a more proactive strategy in cancer care.
What evidence suggests that the NavDx blood test is effective for detecting HPV-related Oropharyngeal Cancer?
Research has shown that the NavDx blood test can successfully detect HPV-related throat cancer by identifying specific DNA in the blood. This test searches for changes in viral DNA linked to tumors, which strongly indicate these cancers. Studies have demonstrated that NavDx has 100% specificity, correctly identifying individuals with the disease without false positives. This makes it a reliable tool for early detection, which is crucial for improving treatment outcomes.
In this trial, researchers will assess participants with no previous history of diagnosed HPV-related head and neck cancer using the NavDx test to evaluate its effectiveness in early detection.16789Who Is on the Research Team?
Nancy Lee, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Testing
Participants undergo blood testing using NavDx® to detect circulating HPV DNA
Follow-up
Participants are monitored for safety and effectiveness after testing
What Are the Treatments Tested in This Trial?
Interventions
- NavDx
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants have no previous history of diagnosed HPV-related head and neck cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Citations
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.
Use in HPV+ Cancers
Even with successful treatment, 13%-25% of patients with HPV-driven head and neck cancer will experience a recurrence within 5-years.14,17,18 Thirty-three to 52 ...
Performance of Liquid Biopsy for Diagnosis and ...
This cohort study aims to establish the clinical efficacy of plasma tumor tissue–modified human papillomavirus DNA testing in the diagnosis ...
4.
naveris.com
naveris.com/press-release/naveris-announces-launch-of-phase-ii-clinical-study-in-mrd-head-and-neck-cancer/Naveris Launches Phase II MRD+ Cancer Study with ...
Naveris launches a Phase II clinical study exploring MRD detection, precision treatment approaches and improving outcomes for HPV-driven ...
Clinical validity of TTMV-HPV DNA liquid biopsies for the ...
The commercially available NavDx TTMV-HPV DNA assay demonstrated 100% specificity, and therefore excellent positive predictive value, in both diagnosis and ...
The NavDx®Test Result: Surveillance
Tumor tissue modified viral (TTMV®)-HPV DNA is a unique blood-based biomarker that aids in detecting. HPV-driven cancers, such as head and neck cancers.
New NavDx® Data Shared at 2024 AAO-HNS Annual ...
This systematic review assesses the diagnostic accuracy and clinical utility of circulating tumor DNA (ctDNA) technologies in HPV-associated ...
Circulating tumor tissue modified viral (TTMV)-HPV DNA in ...
Circulating Tumor Tissue Modified Viral (TTMV)-HPV DNA (NavDx®) is a clinically available test that has demonstrated favorable accuracy metrics when monitoring ...
9.
wexnermedical.osu.edu
wexnermedical.osu.edu/departments/innovations/ent/novel-test-detects-cancer-dna-in-bloodstreamNovel test detects cancer DNA in bloodstream
The NavDx test takes a patient blood sample, spins it down and then examines the plasma for HPV-related DNA from oropharyngeal cancer cells. The test can ...
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