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

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

NCT ID: NCT05956795

Condition: Cutaneous Squamous Cell Carcinoma of the Head and Neck

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of 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

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Ultrasound
Description: Sonographic imaging will be performed of lymph node basins
Arm group label: BWH stage T2a tumors in patients who are on chronic immunosuppression
Arm group label: BWH stage T2b
Arm group label: BWH stage T3

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.

Criteria for eligibility:

Study pop:
Patients will be recruited from outpatient general dermatology clinics and surgical clinics in The Johns Hopkins system. Patients who are referred to the The Johns Hopkins system for research purposes will also be considered.

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Sibley Memorial Hospital

Address:
City: Washington
Zip: 20016
Country: United States

Status: Recruiting

Contact:
Last name: Kristin Bibee, MD PhD

Facility:
Name: Johns Hopkins Hospital

Address:
City: Baltimore
Zip: 21287
Country: United States

Status: Recruiting

Contact:
Last name: Kristin Bibee, MD PhD

Start date: February 1, 2024

Completion date: December 31, 2028

Lead sponsor:
Agency: Johns Hopkins University
Agency class: Other

Source: Johns Hopkins University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05956795