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Procedure
Sentinel Lymph Node Biopsy for Head and Neck Squamous Cell Carcinoma
N/A
Recruiting
Led By Jessica Yesensky, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to undergo general anesthesia for sentinel lymph node biopsy
Clinically and radiographically regional node-negative (no evidence of regional lymph node metastasis or distant metastasis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 1 year
Awards & highlights
Study Summary
This trial will test if SLNB can help find tumors in patients with node-negative cutaneous squamous cell carcinoma of the head or neck.
Who is the study for?
This trial is for adults over 18 with a specific skin cancer on the head or neck that hasn't spread to lymph nodes or elsewhere. They must be able to have general anesthesia, undergo certain scans with contrast, and consent to the study's procedures.Check my eligibility
What is being tested?
The study tests if sentinel lymph node biopsy (SLNB) can detect hidden tumor cells in patients with cutaneous squamous cell carcinoma of the head or neck who don't show signs of cancer in their lymph nodes.See study design
What are the potential side effects?
Potential side effects from SLNB may include pain, swelling, bruising at the biopsy site, allergic reactions to injected substances used for mapping lymph nodes, and very rarely nerve damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can safely be put under general anesthesia for a biopsy.
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My scans show no cancer spread to nearby lymph nodes or distant areas.
Select...
My skin cancer is in the head or neck area and is moderately to very advanced.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of metastasis
Secondary outcome measures
Evaluate the gene profile of tumor
Evaluate the gene profile via validated 40-gene expression profile (40-GEP) to identify common mutations associated with high-risk tumors characteristics.
Evaluate the tumor variables
Trial Design
1Treatment groups
Experimental Treatment
Group I: Procedure/SurgeryExperimental Treatment1 Intervention
Mohs micrographic surgery followed by sentinel lymph node biopsy
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
989 Previous Clinical Trials
1,093,604 Total Patients Enrolled
Jessica Yesensky, MDPrincipal InvestigatorIndiana University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have surgery that requires being put to sleep.I have a confirmed skin cancer diagnosis from a biopsy.My cancer has spread to nearby lymph nodes or other parts of my body.I cannot receive or am allergic to a specific diagnostic dye.I can safely be put under general anesthesia for a biopsy.I had surgery to remove a tumor within the last 4 weeks.My scans show no cancer spread to nearby lymph nodes or distant areas.My skin cancer is in the head or neck area and is moderately to very advanced.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Procedure/Surgery
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.
What is the participant quota for this clinical trial?
"Affirmative. Clinicaltrials.gov data demonstrate that this investigation is currently recruiting test subjects. This research project, which was first published on October 25th 2021, seeks 94 volunteers from a single medical facility."
Answered by AI
Are there any vacancies for potential volunteers in this trial?
"Affirmative. The clinical trial details hosted on clinicaltrials.gov verify that this medical study, first posted on October 25th 2021, is presently recruiting patients. 94 participants need to be sourced from a single clinic location."
Answered by AI
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