TerminatedNot Applicable

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

Stopped: Expired in IRB

United States1 participantsStarted 2024-02-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Recurrent tumors * Patients who are BWH T2b/T3 who have a positive CT of the nodal basin or positive lymph node biopsy

What they're measuring

Number of participants with Nodal metastasis

Timeframe: From diagnosis up to 2 years

Trial details

NCT IDNCT05956795

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-05-14