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Sentinel Lymph Node Biopsy for Head and Neck Squamous Cell Carcinoma
N/A
Recruiting
Led By Alex Mlynarek, MD
Research Sponsored by Jewish General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Immunocompromised
Size more than 2 cm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years post intervention
Awards & highlights
Study Summary
This trial is investigating whether sentinel lymph node biopsy (SLNB) should be routine practice for people with a type of skin cancer called cutaneous squamous cell carcinoma (cSCC).
Who is the study for?
This trial is for individuals with a type of skin cancer called cutaneous Squamous Cell Carcinoma (cSCC) on the head or neck. Eligible participants must have tumors deeper than 6mm, poorly differentiated cells, nerve invasion over 0.1mm, extensive vessel invasion, tumors larger than 2cm, or be immunocompromised. Those with known lymph node metastases, prior surgeries affecting neck lymph drainage, or who are pregnant/breastfeeding cannot participate.Check my eligibility
What is being tested?
The study is testing Sentinel Lymph Node Biopsy (SLNB) in patients with high-risk cSCC to see if it's effective and when it should be used. Currently there's no consensus on using SLNB routinely; this research could lead to new guidelines for treating regional lymph nodes in these patients.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks associated with surgical biopsies like SLNB may include pain at the biopsy site, infection risk from the incision made during surgery and potential complications related to anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Your immune system is weakened or not working properly.
Select...
The size of the condition being studied is larger than 2 centimeters.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years post intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
predictive value of sentinel lymph node biopsy in cutaneous squamous cell carcinoma
Secondary outcome measures
disease free five year survival
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sentinel Lymph Node BiopsyExperimental Treatment1 Intervention
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.
Group II: Standard of CareActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sentinel Lymph Node Biopsy
2004
Completed Phase 3
~330
Find a Location
Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
437 Previous Clinical Trials
158,923 Total Patients Enrolled
Jewish General HospitalLead Sponsor
137 Previous Clinical Trials
271,946 Total Patients Enrolled
Alex Mlynarek, MDPrincipal InvestigatorJewish General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The size of the condition being studied is larger than 2 centimeters.You are currently pregnant or breastfeeding.Your immune system is weakened or not working properly.
Research Study Groups:
This trial has the following groups:- Group 1: Sentinel Lymph Node Biopsy
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is participation in this experiment widespread?
"Yes, the information hosted on clinicaltrials.gov indicates that this experiment is currently seeking participants. It was first posted in November 26th 2020 and recently updated on April 2nd 2022; it aims to enroll 100 people from one site."
Answered by AI
Are there any availabilities for individuals to join this clinical experiment?
"According to clinicaltrials.gov, this research is actively scouring for appropriate candidates; the original post date was November 26th 2020 and it has been updated most recently on April 2nd 2022."
Answered by AI
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