NCT05956795

Surveillance of Regional Nodal Basins in Patients With Primary High Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this prospective cohort study, investigators will conduct ultrasound surveillance of the nodal basins of patients with head and neck cutaneous squamous cell carcinoma (cSCC) whose tumors are considered high risk and staged by the Brigham and Women's Hospital (BWH) tumor staging system. The study will enroll patients with tumors staged T2a and who are also immunosuppressed (from solid organ transplant, hematologic malignancy or autoimmune disease), T2b (sentinel lymph node negative), and T3 (sentinel lymph node negative). After two years of surveillance, outcomes regarding local recurrence, nodal metastasis, disease specific death, and overall survival will be compared with historical controls with the overall hypothesis that ultrasound surveillance will detect subclinical disease earlier and help improve outcomes.

Conditions

• Cutaneous Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ultrasound	Sonographic imaging will be performed of lymph node basins

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-05-14
• Completion: 2025-05-14
• First posted: 2023-07-21
• Last updated: 2026-03-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study