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.
Study Type
OBSERVATIONAL
Enrollment
470
Sonographic imaging will be performed of lymph node basins
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Number of participants with Nodal metastasis
Metastatic squamous cell carcinoma to lymph node basins will be assessed through regular US surveillance of each cohort group along with review of respective medical records for any subsequent studies that were performed to confirm metastasis during routine care. Review of medical records will be conducted for historical controls. Investigators will then compare time to nodal metastasis between the US surveillance group and the historical controls using Kaplan-Meier estimates of the survivor function and a log-rank test. The investigators will also use Cox proportional-hazards regression to estimate the hazard ratio of nodal metastasis between these two group while adjusting for the covariates of age, sex, stage, etc.
Time frame: From diagnosis up to 2 years
Number of participants with local recurrence of squamous cell carcinoma
Recurrent squamous cell carcinoma in the original excision site will be confirmed by review of respective medical records/charts for subsequent confirmation studies performed during routine care. Investigators will use Kaplan-Meier estimates, a log-rank test, and Cox proportional-hazards to compare time to local recurrence between groups
Time frame: From diagnosis up to 2 years
Disease specific death
Death from cutaneous squamous cell carcinoma will be determined by review of medical records. Investigators will compare two-year disease-specific mortality rates between groups using a test of two proportions followed by logistic regression to allow adjustment for covariates.
Time frame: From diagnosis up to 2 years
Overall survival rate
The percentage of participants in each cohort who are still alive at the end of the study. Investigators will compare two-year overall mortality rates between groups using a test of two proportions followed by logistic regression to allow adjustment for covariates
Time frame: From diagnosis up to 2 years
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