Cutaneous Squamous Cell Carcinoma of the Head and Neck
Conditions
Keywords
ultrasound, Brigham and Women's Hospital Staging, high risk cutaneous squamous cell carcinoma, head and neck, lymph node basins, immunosuppressed, BWH
Brief 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.
Interventions
DIAGNOSTIC_TESTUltrasound
Sonographic imaging will be performed of lymph node basins
Sponsors
Johns Hopkins University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Nodal metastasis | From diagnosis up to 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with local recurrence of squamous cell carcinoma | From diagnosis up to 2 years | 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 |
| Disease specific death | From diagnosis up to 2 years | 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. |
| Overall survival rate | From diagnosis up to 2 years | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKristin Bibee, MD
Johns Hopkins University
Outcome results
None listed