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

Johns Hopkins University

Status: Active, not recruiting

Conditions: Cutaneous Squamous Cell Carcinoma of the Head and Neck

Treatments: Diagnostic Test: Ultrasound

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05956795

IRB00270545

Details and patient eligibility

About

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.

Enrollment: 470 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

470 participants in 3 patient groups

BWH stage T2a tumors in patients who are on chronic immunosuppression

Description:

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).

Treatment:

Diagnostic Test: Ultrasound

BWH stage T2b

Description:

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).

Treatment:

Diagnostic Test: Ultrasound

BWH stage T3

Description:

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).

Treatment:

Diagnostic Test: Ultrasound