Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Testing Whether Skin Cancer Has Spread to Nearby Lymph Nodes (CECRE)

18 augusti 2026 uppdaterad av: Germans Trias i Pujol Hospital

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

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

142

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Spanien
    • Barcelona
      • Badalona, Barcelona, Spanien, 08916
        • Rekrytering
        • Germans Trias i Pujol Universitary Hospital
        • Kontakt:
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Conventional treatmeng
Patients with high risk cutaneous squamous cell carcinoma who do not perform SBSG and do not present N1 at the time of diagnosis.
Experimentell: early treatment of subclinical metastases
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.
Procedur: 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 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall survival
Tidsram: 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.
Up to 5 years since intervention

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Disease-free time
Tidsram: 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.
Up to 5 years since intervention
Regional metastases
Tidsram: 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
Up to 5 years since intervention
Remote metastases
Tidsram: Up to 5 years since intervention
clinical and/or radiological presence of metastases outside the lymphatic drainage territory
Up to 5 years since intervention
Local recurrence
Tidsram: Up to 5 years since intervention
reappearance of the lesion in the same location once treated
Up to 5 years since intervention

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Germans Trias i Pujol Hospital

Samarbetspartners

Fundació Institut Germans Trias i Pujol

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 juli 2014

Primärt slutförande (Beräknad)

1 januari 2028

Avslutad studie (Beräknad)

1 april 2028

Studieregistreringsdatum

Först inskickad

28 juli 2026

Först inskickad som uppfyllde QC-kriterierna

30 juli 2026

Första postat (Faktisk)

5 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 augusti 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CECRE

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera