Can a targeted biopsy replace full neck surgery for High-Risk skin cancer?

NCT ID NCT06990737

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether sentinel lymph node biopsy (SLNB) can safely guide treatment for people with high-risk squamous cell carcinoma of the head and neck that has not spread to lymph nodes. Participants receive either SLNB or a more extensive lymph node removal, and researchers compare how long they stay free of cancer. The goal is to see if the less invasive procedure works as well and causes fewer side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sentinel lymph node biopsy (SLNB), a surgical procedure to remove and check the first lymph nodes that drain the tumor area, compared with standard lymph node removal (lymphadenectomy).
What this could lead to
If SLNB proves effective, it could become a standard, less invasive way to guide treatment for high-risk head and neck skin cancer, potentially improving survival and reducing unnecessary surgery.
What could go wrong
This is a phase 2 trial at one site, so results may not apply broadly. SLNB may miss cancer spread, and surgery carries risks like infection or nerve damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Started

Jun 2025

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Must have histologically and/or biochemically confirmed head and neck cSCC 2. Must have head and neck cSCC categorized as high risk: 1. Location in the ear or the lip, 2. Diameter greater than 2 cm, 3. Depth greater than 4 mm, 4. Perineural invasion, 5. Poorly differentiated, and/or 6. Recurrent disease 3. Lymph-node negative (cN0) status confirmed by computed tomography (CT) imaging. 4. Candidate for surgical intervention with sentinel lymph node biopsy (SLNB) and potential lymphadenectomy for treatment of cSCC. 5. Zubrod Performance Status 0-2 6. Age ≥18 years at time of consent. 7. Provision of signed and dated informed consent form. 8. Stated willingness to comply with all study procedures and availability for the duration of the study. Exclusion Criteria: 1. Other active cancers. 2. Definitive clinical or radiologic evidence of regional (cervical) and/or distant metastatic disease. 3. Prior non-head and neck invasive malignancy (except non-melanomatous skin cancer, including effectively treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix) unless disease free for ≥ 2 years. 4. Diagnosis of head and neck mucosal SCC. 5. Prior systemic chemotherapy for head and neck mucosal SCC; note that prior chemotherapy for a different cancer is allowable. 6. Prior radiotherapy to the head and neck that would result in overlap of radiation therapy fields. 7. Patient with severe, active co-morbidity that would preclude a lymphadenectomy. 8. Pregnant or breast-feeding persons. 9. Prior surgery involving the lateral neck, including neck dissection or gross injury to the neck that would preclude surgical dissection for this trial. Prior thyroid and central neck surgery is permissible; biopsy is permitted. Prior surgery for confirmation of tumor pathology is permitted. Note: Borderline suspicious nodes that are ≥1 cm with radiographic finding suggestive of NOT malignant should be biopsied using U/S-guided fine-needle aspirate (FNA) biopsy. 10. Underlying or documented history of hematologic malignancy (e.g., chronic lymphocytic leukemia) or other active disease capable of causing lymphadenopathy (sarcoidosis or untreated mycobacterial infection). 11. Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte, or immunomodulatory therapy. 12. Currently participating in another investigational therapeutic trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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