Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Seeing if the first lymph node helps detect skin cancer spread earlier

Official title: Sentinel Lymph Node Biopsy in High-Risk Cutaneous Squamous Cell Carcinoma

Run by Germans Trias i Pujol Hospital · NCT07746258 · Data updated 2026-11-12

They are testing whether checking the sentinel lymph node early can help see if high-risk skin squamous cell cancer has started to spread.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment142 (estimated)
SponsorGermans Trias i Pujol Hospital
Academic / other
Locations1 site (Badalona, Barcelona)
StatusRecruiting
StartedJuly 25, 2014
Main results expectedJanuary 2028
Study endsApril 2028
Registry record updatedAugust 19, 2026
Trial IDNCT07746258 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with high-risk HRcSCC without known distant metastases and meeting the specified diagnostic criteria.

Probably not a fit

Patients whose cancer does not spread to the sentinel node or who have contraindicating conditions may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study looks at high-risk cutaneous squamous cell carcinoma and whether proactive examination of the sentinel lymph node can improve outcomes. The study will use lymphadenectomy to remove the sentinel node in participants without evident metastasis. Enrollment targets 142 participants diagnosed with HRcSCC who have no visible spread at baseline. The approach aims to detect spread earlier than imaging or physical exam might reveal. Results could influence how early lymph node assessment is used in managing HRcSCC.

Why it matters

Potential benefit: If successful, patients may benefit from earlier detection of spread and potentially improved survival.

How similar studies have gone: Other studies have explored sentinel node assessment in skin cancer, with mixed but promising signals about early detection.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Germans Trias i Pujol Universitary Hospital
    Badalona, Barcelona, Spain
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.