Testing Whether Skin Cancer Has Spread to Nearby Lymph Nodes

Official title

Selective Biopsy of Sentinel Ganglion in High-risk Cutaneous Squamous Carcinoma

Overview

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.

Interventions

• Procedure Lymphadenectomy
  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 ganglia. Approximate cutaneous marking with a permanent marker will be performed to facilitate the intraoperative location of the ganglion. 2. Surgical intervention will begin with tumor exeresis to prevent interference that hinders the posterior location of the sentinel ganglion. The sentinel ganglion w

Primary outcome measures

• Overall survival [Time frame: Up to 5 years since intervention]

Secondary outcome measures (4)

• Disease-free time [Time frame: Up to 5 years since intervention]
• Regional metastases [Time frame: Up to 5 years since intervention]
• Remote metastases [Time frame: Up to 5 years since intervention]
• Local recurrence [Time frame: Up to 5 years since intervention]

Eligibility 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:

• 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 1 center

• Germans Trias i Pujol Universitary Hospital — Badalona

Identifiers

NCT: NCT07746258 · CECRE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗