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๐Ÿ›๏ธ Verified NIH Protocol โ€ข Sourced via U.S. National Library of Medicine (Last Synced: 2026-05-12)

De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA

๐ŸŸข Recruiting Phase 2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Mayo Clinic

๐Ÿฉบ Protocol Summary

This phase II trial examines the use of blood-based biomarkers is to help inform decision making for treatment and radiation therapy for patients with human papillomavirus (HPV) positive oropharyngeal squamous cell cancers. The standard treatments for head and neck cancers are radiation therapy with chemotherapy or surgery potentially followed by radiation therapy with or without chemotherapy. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving chemotherapy along with radiation may kill more tumor cells. However, the cancer can recur or can spread to other parts of the body and all treatments can be associated with side effects. The purpose of this study is to evaluate a blood-based biomarker, using the NavDx testing device, for head and neck cancers in order to see if it can help improve selection of the intensity of treatment in order to best balance the side effects of treatment with the goal of decreasing cancer recurrence. This test could aid in early detection of recurrence and salvage therapy.

Primary Research Facility: Mayo Clinic in Arizona (Scottsdale, Arizona)

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๐Ÿ“ Primary Site Map

Site: Mayo Clinic in Arizona โ€” Scottsdale, Arizona

๐Ÿ“ All Participating Trial Locations (3 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. Mayo Clinic in Arizona โ€” Scottsdale, Arizona โ€ข Contact: (855) 776-0015
2. Mayo Clinic in Florida โ€” Jacksonville, Florida โ€ข Contact: (855) 776-0015
3. Mayo Clinic in Rochester โ€” Rochester, Minnesota โ€ข Contact: (855) 776-0015

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๐Ÿ’ฐ Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act ยง 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

๐Ÿ’ก Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

๐Ÿ›๏ธ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT05541016 โ€ข Last Synced: 2026-05-12
View on ClinicalTrials.gov โ†—
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