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NCT07513389 · ClinicalTrials.gov registry record · Phase 2
Omission of Postoperative Radiation in HPV-Associated Oropharyngeal Cancer Using ctHPVDNA Surveillance (OPERATION)
A Phase 2 study, sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT07513389 is a Phase 2 study that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 36 participants.
The verdict
NCT07513389, a Phase 2 study, is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
This single-arm Phase II trial evaluates whether omission of postoperative radiotherapy is feasible and oncologically safe in select patients with HPV-associated oropharyngeal squamous cell carcinoma (HPV-OPSCC). Eligible patients undergo transoral robotic surgery (TORS) and are observed without adjuvant radiation if they demonstrate low or intermediate pathological risk features and have negative circulating tumor HPV DNA (ctHPVDNA) two weeks post-operatively. Patients are followed with standard clinical surveillance combined with serial ctHPVDNA testing (NavDx®) to facilitate early detection of recurrence and prompt salvage therapy as needed.
Interventions
- OTHER Active Surveillance With ctHPVDNA (NavDx®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2026-10-01 |
| Est. Completion | 2030-07-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07513389
The ClinicalTrials.gov registry entry for NCT07513389 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Active Surveillance With ctHPVDNA (NavDx®) is the first listed.
NCT07513389 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07513389 about?
NCT07513389 is a clinical study titled "Omission of Postoperative Radiation in HPV-Associated Oropharyngeal Cancer Using ctHPVDNA Surveillance (OPERATION)". This single-arm Phase II trial evaluates whether omission of postoperative radiotherapy is feasible and oncologically safe in select patients with HPV-associated oropharyngeal squamous cell carcinoma (HPV-OPSCC). Eligible patients undergo transoral robotic surgery (TORS) and are observed without adj...
What is the current status of trial NCT07513389?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2026-10-01. Estimated completion is 2030-07-01.
What interventions are being tested in trial NCT07513389?
The interventions under investigation include: Active Surveillance With ctHPVDNA (NavDx®) (OTHER).
Who is sponsoring clinical trial NCT07513389?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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