Testing Whether Skin Cancer Has Spread to Nearby Lymph Nodes

NCT07746258 | Recruiting

• 1 other identifier: CECRE
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

This study is about a type of skin cancer called high-risk cutaneous squamous cell carcinoma (HRcSCC). Although most people with this type of skin cancer are successfully treated, some patients have a higher chance that the cancer will spread to nearby lymph nodes. When this happens, treatment becomes more difficult and the chances of recovery are lower. The aim of this study is to find out whether looking for cancer spread at a very early stage can improve patients' health and survival. The study focuses on the sentinel lymph node, which is the first lymph node that fluid from the skin tumour reaches. If cancer cells begin to spread, this is usually the first place where they are found. By examining this lymph node, doctors may be able to detect cancer spread before it can be seen on scans or felt during a physical examination. A total of 142 participants with high-risk skin cancer who have no signs of cancer spread at the time of diagnosis will take part in this study. Participants will be randomly assigned (like flipping a coin) to one of two groups: Sentinel lymph node biopsy group: Participants will have the usual surgery to remove the skin cancer, together with a small operation to remove the sentinel lymph node. If cancer cells are found in this lymph node, doctors may recommend further treatment, such as surgery to remove additional nearby lymph nodes. Standard care group: Participants will receive the current standard treatment, which includes surgery to remove skin cancer followed by regular follow-up visits. Further treatment will only be given if there are later signs that the cancer has spread. Both groups will receive the same regular follow-up care for five years, including medical examinations and imaging tests to check for any signs that the cancer has returned or spread. Researchers will compare the two groups to determine whether examining the sentinel lymph node helps doctors detect cancer spread earlier, reduces the chance of the cancer returning, and improves long-term survival. The study will also help identify which patients are most likely to benefit from this approach.

Conditions

Cutaneous Squamous Cell Carcinoma (CSCC)

Keywords

Cutaneous squamos Carcinoma; Sentinel nodul

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Time (days) elapsed between diagnosis and death of the patient attributable to the disease before the end of the follow-up period.

  Up to 5 years since intervention

Secondary Outcomes (4)

• Disease-free time

  Up to 5 years since intervention

• Regional metastases

  Up to 5 years since intervention

• Remote metastases

  Up to 5 years since intervention

• Local recurrence

  Up to 5 years since intervention

Study Arms (2)

early treatment of subclinical metastases

EXPERIMENTAL

Lymphadenectomy will be practiced when the selective biopsy of sentinel node (SBSN) is positive (SBSN +). In patients with T3 or higher N0 and lip carcinoma (since the current protocol indicates performing cervical lymphadenectomy), SBSG will be performed and at the same time of surgery, elective cervical lymphadenectomy.

Procedure: Lymphadenectomy

Conventional treatmeng

NO INTERVENTION

Patients with high risk cutaneous squamous cell carcinoma who do not perform SBSG and do not present N1 at the time of diagnosis.

Interventions

Lymphadenectomy PROCEDURE

1. Lymphogampigraphy. A planar lymphogampigraphy will be performed, and Single Photon Emission Computed Tomography (SPECT) study if necessary, to study the location of the lymph node or sentinel node. Approximate cutaneous marking with a permanent marker will be performed to facilitate the intraoperative location of the node. 2. Surgical intervention will begin with tumor exeresis to prevent interference that hinders the posterior location of the sentinel node. The sentinel node will then be detected with the help of a portable gammagraphic probe. The surgeon will practice a small cutaneous incision through which we will introduce the probe, performing a tracing from more superficial planes to deeper planes. Once located, the sentinel node will be biopsied and is counted on ex vivo radioactivity. In those patients where it is indicated to perform elective cervical lymphadenectomy.

early treatment of subclinical metastases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with HRcSCC according to the criteria established in the following table.
• Diagnosis of HRcSCC will be made if it complies:
• major criteria
• major criteria and 2 minor criteria
• major criteria and 4 minor criteria.
• Major clinical criteria: Major histological criteria:
• Dystrophic epidermolysis ampollosa
• Epidermodysplasia verruciforme
• Congenital dyskeratosis Major tumor thickness of 6 mm.
• Pigmentose xeroderm
• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead
• Fundació Institut Germans Trias i Pujol: collaborator

Study Sites (1)

Germans Trias i Pujol Universitary Hospital

Badalona, Barcelona, 08916, Spain

RECRUITING

MeSH Terms

Interventions

Lymph Node Excision

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 5, 2026
• Study Start: July 25, 2014
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: August 19, 2026

Record last verified: 2026-07

Locations

ES (1)