NavDx for Oropharyngeal Cancer

Not currently recruiting at 6 trial locations
NL
VH
Overseen ByVaios Hatzoglou, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.16789

Who Is on the Research Team?

NL

Nancy Lee, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Ages 45 and older
Self-reported history of four or more lifetime sexual partners
Self-reported history of one or more lifetime oral sexual partner
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 5 years

Testing

Participants undergo blood testing using NavDx® to detect circulating HPV DNA

Follow-up

Participants are monitored for safety and effectiveness after testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NavDx
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: No previous history of diagnosed HPV-related head and neck cancerExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

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+ CancersEven 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 ...
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: SurveillanceTumor 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 ...
Novel test detects cancer DNA in bloodstreamThe 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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