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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cutaneous Squamous Cell Carcinoma of the Head and Neck

Intervention / Treatment
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* Diagnostic Test: Ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BWH stage T2a tumors in patients who are on chronic immunosuppression<br>Patient's whose cutaneous squamous cell carcinoma is BWH stage T2a and also have a history of organ transplant, hematologic malignancy, autoimmune disease. After these participants are diagnosed, the participants are entered into the study without any further imaging or sentinel lymph node biopsy. The participants will have ultrasound surveillance every 6 months and regular visits every 3 months throughout the duration of the study (2 years). | Diagnostic Test: Ultrasound<br>* Sonographic imaging will be performed of lymph node basins<br>|
| BWH stage T2b<br>Participants whose cutaneous squamous cell carcinoma is BWH stage T2b. Participants will initially undergo CT imaging of the nodal basin immediately after diagnosis. If the CT is positive, the participants will be excluded from the study. If the CT is unremarkable, patients will undergo sentinel lymph node biopsy (SLNB), which has a higher sensitivity to detect occult micro-metastases. If the SLNB is negative, the participants are entered into the study. The participants will have ultrasound surveillance every 6 months and regular visits every 3 months throughout the duration of the study (2 years). | Diagnostic Test: Ultrasound<br>* Sonographic imaging will be performed of lymph node basins<br>|
| BWH stage T3<br>Participants whose cutaneous squamous cell carcinoma is BWH stage T3. Participants will initially undergo CT imaging of the nodal basin immediately after diagnosis. If the CT is positive, The participants will be excluded from the study. If the CT is unremarkable, patients will undergo sentinel lymph node biopsy (SLNB), which has a higher sensitivity to detect occult micro-metastases. If the SLNB is negative, the participants are entered into the study The participants will have ultrasound surveillance every 6 months and regular visits every 3 months throughout the duration of the study (2 years). | Diagnostic Test: Ultrasound<br>* Sonographic imaging will be performed of lymph node basins<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From diagnosis up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | From diagnosis up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasound, Brigham and Women's Hospital Staging, high risk cutaneous squamous cell carcinoma, head and neck, lymph node basins, immunosuppressed, BWH