Clinical trial NCT05956795: Surveillance of Regional Nodal Basins in Patients With Primary High Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck
Official title: Surveillance of Regional Nodal Basins in Patients With Primary High Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cutaneous Squamous Cell Carcinoma of the Head and Neck
Keywords: ultrasound
Brigham and Women's Hospital Staging
high risk cutaneous squamous cell carcinoma
head and neck
lymph node basins
immunosuppressed
BWH
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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

Primary outcomes:
measure: Number of participants with Nodal metastasis
timeFrame: From diagnosis up to 2 years
Secondary outcomes:
measure: Number of participants with local recurrence of squamous cell carcinoma
timeFrame: From diagnosis up to 2 years
measure: Disease specific death
timeFrame: From diagnosis up to 2 years
measure: Overall survival rate
timeFrame: From diagnosis up to 2 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kristin Bibee, MD
role: PRINCIPAL_INVESTIGATOR
References:
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