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NCT06088381 · ClinicalTrials.gov registry record · Phase 2
Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)
A Phase 2 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
- 5
- Study locations
NCT06088381 is a Phase 2 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 61 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (77% lower). The trial reports 5 study locations across 1 state.
The verdict
NCT06088381, a Phase 2 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
- 5
- Study locations
Study Summary
Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have favorable outcomes and how well they do depends on the specific details about the patient and their cancer. How well they do isn't as related to the kinds of treatment they get. However, there are significant side effects for the various types of treatments they may get. Because these patients generally have favorable outcomes no matter the kind of treatment, reducing side effects should be a priority when choosing their treatment. The goal of this clinical research study is to evaluate whether a new blood test called a Circulating Tumor DNA test (ctDNA test) can decrease the number of people that require radiation after surgery. This blood test is often elevated in people when they are diagnosed with head and neck cancer. There are studies that show that cancer most often returns when this blood test is positive after treatment. This study will test patients' blood before and after surgery. In cases where the test is negative after surgery, people on the study will not receive radiation unless they are considered high risk based on surgery findings. The hope is that radiation and its potential side effects can be limited to only people that need the treatment.
Conditions Studied
Interventions
- OTHER Experimental Observation
- OTHER Observation per Standard of Care
- RADIATION Adjuvant Treatment per Standard of Care
- DIAGNOSTIC_TEST Circulating Tumor DNA test (ctDNA test)
Study Locations (5)
Maryland
- Maryland Proton Treatment Center - Baltimore
- University of Maryland Greenebaum Cancer Center - Baltimore
- Upper Chesapeake Health - Bel Air
- Central Maryland Radiation Oncology - Columbia
- Baltimore Washington Medical Center - Glen Burnie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2024-03-07 |
| Est. Completion | 2030-12-18 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06088381
The ClinicalTrials.gov registry entry for NCT06088381 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (77% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 4 interventions - of which Experimental Observation is the first listed.
NCT06088381 reports 5 study locations spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06088381 about?
NCT06088381 is a clinical study titled "Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)". Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have favorable outcomes and how well they do depends on the specific details about the patient and their cancer. How well they do isn't as related to the kinds of treatment they get. However, there are significant side e...
What is the current status of trial NCT06088381?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2024-03-07. Estimated completion is 2030-12-18.
What conditions does trial NCT06088381 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Oropharynx Cancer, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Oropharynx Squamous Cell Carcinoma.
What interventions are being tested in trial NCT06088381?
The interventions under investigation include: Experimental Observation (OTHER), Observation per Standard of Care (OTHER), Adjuvant Treatment per Standard of Care (RADIATION), Circulating Tumor DNA test (ctDNA test) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06088381?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06088381 being conducted?
This trial has 5 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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