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NCT Number: NCT07746258

Testing Whether Skin Cancer Has Spread to Nearby Lymph Nodes

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.

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Key information

Conditions

Cutaneous Squamous Cell Carcinoma (CSCC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lymphadenectomy

Procedure
  • 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.
  • Surgical intervention will begin with tumor exeresis to prevent interference that hinders the posterior location of the sentinel ganglion. The sentinel ganglion 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 ganglion will be biopsied and is counted on ex vivo radioactivity. In those patients where it is indicated to perform elective cervical lymphadenectomy.

Primary outcomes

  1. Overall survival

    Time frame: Up to 5 years since intervention

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

Secondary outcomes

  1. Disease-free time

    Time frame: Up to 5 years since intervention

    Disease free time: Time (days) elapsed between the end of treatment and the appearance of disease in the form of local, regional and/or remote recurrence.

  2. Regional metastases

    Time frame: Up to 5 years since intervention

    Clinical and/or radiological presence of adenopathies in the territory of tumor drainage including metastases in transit since intervention to 5 years later

  3. Remote metastases

    Time frame: Up to 5 years since intervention

    clinical and/or radiological presence of metastases outside the lymphatic drainage territory

  4. Local recurrence

    Time frame: Up to 5 years since intervention

    reappearance of the lesion in the same location once treated

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Collaborators

  • Fundació Institut Germans Trias i Pujol

Registry information

Official study title

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

Acronym: CECRE

Important dates

Study start
2014
Primary completion
2028
Study completion
2028
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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