Recruiting

Observational Study

Sponsor:

Jewish General Hospital

Code:

NCT04664582

Conditions

Cutaneous Squamous Cell Carcinoma

Sentinel Lymph Node

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sentinel Lymph Node Biopsy

Study Details

Brief summary:

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.

Conditions

Cutaneous Squamous Cell Carcinoma

Sentinel Lymph Node

Study ID

NCT04664582

Start date

Nov 26, 2020

Status verified date

Apr, 2022

Completion date

Dec 30, 2023

Anticipated

Primary completion date

Dec 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sentinel Lymph Node Biopsy

Lymphoscintigraphy will be ordered alongside usual pre-operative investigations. Intra-operatively, the excision of the primary tumor will be done with the aim of histologically clear margins and appropriate closure as per routine practice at the operating surgeon's discretion. The patients are injected with technicium 99 pre-operatively and a sentinel lymph node biopsy will be performed with a handheld gamma probe.

no intervention: Standard of Care

These patients will be treated with standard of care, which is wide local excision of the primary tumor without performance of sentinel lymph node biopsy, if not indicated.

Interventions

Sentinel Lymph Node Biopsy

see intervention group description

Primary outcome measure

  • predictive value of sentinel lymph node biopsy in cutaneous squamous cell carcinoma [ Time Frame: 1 month after feasibility recruitment completed (anticipated Dec 2021) ]

Central Contacts and Locations

Central contacts

Sena Turkdogan, MD

5147308461sena.turkdogan@mail.mcgill.ca

Locations

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Sena Turkdogan

5147308461senatn@hotmail.com

More Information

Sponsor

Jewish General Hospital

Last update posted

Apr 5, 2022

Last verified

Apr, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jewish General Hospital on 2022-04-05.