Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

18. august 2026 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

142

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Spania
    • Barcelona
      • Badalona, Barcelona, Spania, 08916
        • Rekruttering
        • Germans Trias i Pujol Universitary Hospital
        • Ta kontakt med:
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: 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.
Eksperimentell: 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.
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall survival
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Disease-free time
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 5 years since intervention
reappearance of the lesion in the same location once treated
Up to 5 years since intervention

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Germans Trias i Pujol Hospital

Samarbeidspartnere

Fundació Institut Germans Trias i Pujol

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. juli 2014

Primær fullføring (Antatt)

1. januar 2028

Studiet fullført (Antatt)

1. april 2028

Datoer for studieregistrering

Først innsendt

28. juli 2026

Først innsendt som oppfylte QC-kriteriene

30. juli 2026

Først lagt ut (Faktiske)

5. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. august 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CECRE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere