Sentinel Lymph Node Clinical Trial
Official title:
Sentinel Lymph Node Biopsy for Cutaneous Squamous Cell Carcinoma of the Head and Neck - A Multi-Institutional Prospective Study
Current guidelines in management of regional lymph node metastases for cSCC patients include surgical resection with or without adjuvant therapy as well as chemotherapy and interdisciplinary management; in advanced disease, supportive and palliative care is recommended. These guidelines also define the role of SLNB in management of high-risk cSCC as unclear and suggest further studies need to determine its utility and indications11. Currently, routine practice of performing SLNB in cSCC varies across Quebec and within Canada. At many institutions, SLNB is not routinely performed on patients with cSCC. The current standard of treatment is to observe closely when a patient is deemed to have a high-risk cancer, and if they have clinical or radiological findings of lymphadenopathy, a formal surgical neck dissection is performed. Given the comorbidities and risks involved in treatment of regional lymph nodes in cSCC, the role of SLNB in cSCC patients needs further clarification. This multicentre prospective study aims to better clarify this role and formulate suggested criteria for its indications.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 30, 2023 |
Est. primary completion date | December 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: high risk features rendering the patient eligible for SLNB in this study will include two or more of the following clinical or pathological features: - Immunocompromised - Size more than 2 cm - Depth more than 6 mm - Poorly differentiated histology - Perineural invasion > 0.1mm - Extensive lymphovascular invasion Exclusion Criteria: - Evidence of lymph node metastasis (clinical, radiological, or pathological) - Previous surgery altering lymphatic drainage of the head and neck, such as a prior neck dissection or prior neck irradiation - Pregnancy of breast-feeding |
Country | Name | City | State |
---|---|---|---|
Canada | Jewish General Hospital | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Jewish General Hospital | McGill University Health Centre/Research Institute of the McGill University Health Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | predictive value of sentinel lymph node biopsy in cutaneous squamous cell carcinoma | 1 month after feasibility recruitment completed (anticipated Dec 2021) | ||
Secondary | disease free five year survival | 5 years post intervention |
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