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

Stopped early

Conditions studied: Cutaneous Squamous Cell Carcinoma of the Head and Neck

In brief

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.

Key facts

Study ID

NCT05956795

Run by

Johns Hopkins University

People needed

1

Starts

2024-02-01

Expected to finish

2025-05-14

Last updated by the study team

2026-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All cSCC must be on the head or neck
• All cSCC must be primary tumors.
• BWH stage T2a tumors in patients who are on chronic immunosuppression (organ transplant, hematologic malignancy, autoimmune disease)
• All BWH T2b or T3 tumors with a negative CT of the nodal basin AND a negative SLNB

You may not qualify if…

• Recurrent tumors
• Patients who are BWH T2b/T3 who have a positive CT of the nodal basin or positive lymph node biopsy

Where it is running

• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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