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Can a tiny biopsy outsmart skin Cancer's spread?

NCT ID NCT07746258

Disease control Sponsor: Germans Trias i Pujol Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 05, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This trial tests whether removing and examining the sentinel lymph node—the first node a skin cancer might spread to—can catch metastasis earlier than standard monitoring. Half of the 142 participants with high-risk cutaneous squamous cell carcinoma will receive the biopsy plus standard surgery, while the other half gets standard care alone. Researchers will compare survival and recurrence rates over five years to see if this early detection strategy improves outcomes.

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 procedure
What this could lead to
If successful, this approach could detect cancer spread earlier, potentially improving survival and guiding more effective treatment for high-risk skin cancer patients.
What could go wrong
The trial is relatively small and early-stage. The biopsy may not improve outcomes, could cause surgical complications, or may not benefit all patients equally.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 142 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2014

Expected to finish

Apr 2028

An estimate. End dates often move.

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: Patients with HRcSCC according to the criteria established in the following table. Diagnosis of HRcSCC will be made if it complies: * 3 major criteria * 2 major criteria and 2 minor criteria * 1 major criteria and 4 minor criteria. Major clinical criteria: Major histological criteria: 1. Dystrophic epidermolysis ampollosa 2. Epidermodysplasia verruciforme 3. Congenital dyskeratosis Major tumor thickness of 6 mm. 4. Pigmentose xeroderm 5. Oculocutaneous albinism * Immunosuppression by: Perineural invasion Pulmonary transplantation to heart Hematological disease * Location: lip, anogenital, atrial pavilion Bone infiltration * Tumor recurrence * Major tumor diameter of 5 cm. * Sign informed consent Exclusion Criteria: * \- Presence of clinically obvious metastases (N1) * Concomitan pathologies with high risk of lethality. * Concomitan pathologies that contraindicate the test. * Pregnancy * Breastfeeding * T3 or T4 of lip are excluded. These patients will be performed cervical lymphadenectomy by protocol.

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Conditions

The condition(s) this trial relates to.

skin squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cutaneous squamous cell carcinoma (CSCC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Germans Trias i Pujol Universitary Hospital

    RECRUITING

    Badalona, Barcelona, 08916, Spain

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